An mHealth Pain Coping Skills Training Intervention for Hematopoietic Stem Cell Transplantation Patients: Development and Pilot Randomized Controlled Trial

Background Pain is a challenge for patients following hematopoietic stem cell transplantation (HCT). Objective This study aimed to develop and test the feasibility, acceptability, and initial efficacy of a Web-based mobile pain coping skills training (mPCST) protocol designed to address the needs of HCT patients. Methods Participants had undergone HCT and reported pain following transplant (N=68). To guide intervention development, qualitative data were collected from focus group participants (n=25) and participants who completed user testing (n=7). After their input was integrated into the mPCST intervention, a pilot randomized controlled trial (RCT, n=36) was conducted to examine the feasibility, acceptability, and initial efficacy of the intervention. Measures of acceptability, pain severity, pain disability, pain self-efficacy, fatigue, and physical disability (self-report and 2-min walk test [2MWT]) were collected. Results Participants in the focus groups and user testing provided qualitative data that were used to iteratively refine the mPCST protocol. Focus group qualitative data included participants’ experiences with pain following transplant, perspectives on ways to cope with pain, and suggestions for pain management for other HCT patients. User testing participants provided feedback on the HCT protocol and information on the use of videoconferencing. The final version of the mPCST intervention was designed to bridge the intensive outpatient (1 in-person session) and home settings (5 videoconferencing sessions). A key component of the intervention was a website that provided personalized messages based on daily assessments of pain and activity. The website also provided intervention materials (ie, electronic handouts, short videos, and audio files). The intervention content included pain coping advice from other transplant patients and instructions on how to apply pain coping skills while engaging in meaningful and leisure activities. In the RCT phase of this research, HCT patients (n=36) were randomized to receive the mPCST intervention or to proceed with the treatment as usual. Results revealed that the mPCST participants completed an average of 5 out of 6 sessions. The participants reported that the intervention was highly acceptable (mean 3/4), and they found the sessions to be helpful (mean 8/10) and easy to understand (mean 7/7). The mPCST participants demonstrated significant improvements in pre- to post-treatment pain, self-efficacy (P=.03, d=0.61), and on the 2MWT (P=.03, d=0.66), whereas the patients in the treatment-as-usual group did not report any such improvements. Significant changes in pain disability and fatigue were found in both groups (multiple P<.02); the magnitudes of the effect sizes were larger for the mPCST group than for the control group (pain disability: d=0.79 vs 0.69; fatigue: d=0.94 vs 0.81). There were no significant changes in pain severity in either group. Conclusions Using focus groups and user testing, we developed an mPCST protocol that was feasible, acceptable, and beneficial for HCT patients with pain. Trial Registration ClinicalTrials.gov NCT01984671; https://clinicaltrials.gov/ct2/show/NCT01984671 (Archived by WebCite at http://www.webcitation.org/6xbpx3clZ)

1a-i) Identify the mode of delivery in the title Identify the mode of delivery. Preferably use "web-based" and/or "mobile" and/or "electronic game" in the title. Avoid ambiguous terms like "online", "virtual", "interactive". Use "Internet-based" only if Intervention includes non-web-based Internet components (e.g. email), use "computer-based" or "electronic" only if orine products are used. Use "virtual" only in the context of "virtual reality" (3-D worlds). Use "online" only in the context of "online support groups". Complement or substitute product names with broader terms for the class of products (such as "mobile" or "smart phone" instead of "iphone"), especially if the application runs on different platforms.
Does your paper address subitem 1a-i? * Copy and paste relevant sections from manuscript title (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briesy explain why the item is not applicable/relevant for your study "mHealth" subitem not at all important 1 2 3 4 5 essential subitem not at all important 1 2 3 4 5 essential 1a-ii) Non-web-based components or important co-interventions in title Mention non-web-based components or important co-interventions in title, if any (e.g., "with telephone support").
Does your paper address subitem 1a-ii?
Copy and paste relevant sections from manuscript title (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briesy explain why the item is not applicable/relevant for your study Your answer 1a-iii) Primary condition or target group in the title Mention primary condition or target group in the title, if any (e.g., "for children with Type I Diabetes") Example: A Web-based and Mobile Intervention with Telephone Support for Children with Type I Diabetes: Randomized Controlled Trial Does your paper address subitem 1a-iii? * Copy and paste relevant sections from manuscript title (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briesy explain why the item is not applicable/relevant for your study "Hematopoietic Stem Cell Transplantation Patients" 1b) ABSTRACT: Structured summary of trial design, methods, results, and conclusions subitem not at all important 1 2 3 4 5 essential Does your paper address subitem 1b-i? * Copy and paste relevant sections from the manuscript abstract (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briesy explain why the item is not applicable/relevant for your study This study aimed to develop and test the feasibility, acceptability, and initial ejcacy of a Web-based mobile pain coping skills training (mPCST) protocol designed to address the needs of HCT patients. To guide intervention development, qualitative data were collected from focus group participants (n=25) and participants who completed user testing (n=7). After their input was integrated into the mPCST intervention, a pilot randomized controlled trial (RCT, n=36) was conducted to examine the feasibility, acceptability, and initial ejcacy of the intervention. The Unal version of the mPCST intervention was designed to bridge the intensive outpatient (1 in-person session) and home settings (5 videoconferencing sessions). A key component of the intervention was a website that provided personalized messages based on daily assessments of pain and activity. The website also provided intervention materials (ie, electronic handouts, short videos, and audio Ules). The intervention content included pain coping advice from other transplant patients and instructions on how to apply pain coping skills while engaging in meaningful and leisure activities. The intervention, website and participant materials are all based on cognitive behavioral theory and social cognitive theory.
1b-ii) Level of human involvement in the METHODS section of the ABSTRACT Clarify the level of human involvement in the abstract, e.g., use phrases like "fully automated" vs. "therapist/nurse/care provider/physician-assisted" (mention number and expertise of providers involved, if any). (Note: Only report in the abstract what the main paper is reporting. If this information is missing from the main body of text, consider adding it) subitem not at all important 1 2 3 4 5 essential Does your paper address subitem 1b-ii?
Copy and paste relevant sections from the manuscript abstract (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briesy explain why the item is not applicable/relevant for your study Your answer 1b-iii) Open vs. closed, web-based (self-assessment) vs. face-toface assessments in the METHODS section of the ABSTRACT Mention how participants were recruited (online vs. orine), e.g., from an open access website or from a clinic or a closed online user group (closed usergroup trial), and clarify if this was a purely web-based trial, or there were face-to-face components (as part of the intervention or for assessment). Clearly say if outcomes were self-assessed through questionnaires (as common in web-based trials). Note: In traditional orine trials, an open trial (open-label trial) is a type of clinical trial in which both the researchers and participants know which treatment is being administered. To avoid confusion, use "blinded" or "unblinded" to indicated the level of blinding instead of "open", as "open" in web-based trials usually refers to "open access" (i.e. participants can self-enrol). (Note: Only report in the abstract what the main paper is reporting. If this information is missing from the main body of text, consider adding it) Does your paper address subitem 1b-iii?
Copy and paste relevant sections from the manuscript abstract (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briesy explain why the item is not applicable/relevant for your study

2b) In INTRODUCTION: Specific objectives or hypotheses
Does your paper address subitem 2a-ii? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briesy explain why the item is not applicable/relevant for your study "Persistent pain is a major challenge for patients following hematopoietic stem cell transplantation (HCT). Psychosocial interventions that teach patients with chronic diseases skills to manage their pain can improve their abilities to cope with and reduce the pain. Psychosocial pain protocols are typically delivered inperson, require patients to travel to a medical center setting, and/or are not tailored to the unique challenges faced by HCT patients. Patients undergoing HCT face substantial burden resulting from the life-threatening, chronic illness that has led to HCT, invasive treatment regimens (including HCT), and interruptions to their normal routines and functioning. When undergoing HCT, patients are required to spend several days pre-and post-transplant in an inpatient or intensive outpatient setting. Then, patients and their caregivers transition to temporary housing that is in close proximity to the medical center to receive several weeks of daily outpatient care. Finally, after weeks of intense care in the medical center setting, they are discharged home as they continue to recover, often many miles from the clinic. These unique challenges can increase pain and make pain management particularly dijcult. Using mobile health (mHealth) technologies to deliver psychosocial pain interventions may increase the feasibility, acceptability, and ejcacy of these interventions for HCT patients." METHODS 3a) Description of trial design (such as parallel, factorial) including allocation ratio Does your paper address CONSORT subitem 2b? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briesy explain why the item is not applicable/relevant for your study "The objective of this line of research was to develop a mobile health pain coping skills training (mPCST) protocol, designed to address the speciUc pain and psychosocial challenges of HCT patients. We used an iterative development model to design the protocol; methods from grounded theory were followed.
First, we developed an initial mPCST intervention for HCT patients using our study team's expertise and experience in Pain Coping Skills Training (PCST), cognitive-behavioral pain interventions, mobile health technology, and the treatment of HCT. We then conducted focus groups with both HCT patients and providers to reUne and adapt the intervention. Following this, the enhanced intervention was delivered to a separate small group of patients who completed user testing. Qualitative data gathered from each stage of development were used to inform the subsequent modiUcation of the intervention. A pilot randomized controlled trial (RCT) was conducted to examine the feasibility, acceptability, and initial ejcacy of the Unal mPCST protocol. The Urst aim of the pilot RCT was to show that the mPCST protocol would be feasible (ie, accrual, attrition, and adherence) and acceptable. The second aim was to examine the initial ejcacy of the mPCST protocol (compared with a treatment as the usual condition) on pain severity, pain disability, pain self-ejcacy, fatigue, and physical disability (ie, self-report and 2-min walk test [2MWT])." 3b) Important changes to methods after trial commencement (such as eligibility criteria), with reasons subitem not at all important 1 2 3 4 5 essential Does your paper address CONSORT subitem 3a? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briesy explain why the item is not applicable/relevant for your study "Development: An initial mPCST protocol was developed that was informed by the investigators' expertise in several areas including PCST protocol development, mHealth applications, and observational studies of pain and other symptoms in HCT patients. Focus groups and user testing were conducted to guide investigators in tailoring and reUning the mPCST protocol, intervention website, and participant materials to meet the unique needs of HCT patients with pain. Pilot Randomized Controlled Trial: A separate group of participants (N=36) were randomized to either the mPCST or treatment-as-usual, control group." Does your paper address CONSORT subitem 3b? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briesy explain why the item is not applicable/relevant for your study No changes were made to the study methods after the RCT began.

3b-i) Bug Uxes, Downtimes, Content Changes
Bug Uxes, Downtimes, Content Changes: ehealth systems are often dynamic systems. A description of changes to methods therefore also includes important changes made on the intervention or comparator during the trial (e.g., major bug Uxes or changes in the functionality or content) (5-iii) and other "unexpected events" that may have insuenced study design such as staff changes, system failures/downtimes, etc. [2].

4a) Eligibility criteria for participants
subitem not at all important 1 2 3 4 5 essential Does your paper address subitem 3b-i?
Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briesy explain why the item is not applicable/relevant for your study Your answer Does your paper address CONSORT subitem 4a? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briesy explain why the item is not applicable/relevant for your study "All participants were recruited from the adult bone marrow transplant clinic (ABMT) at a major academic medical center. Eligible patients were >21 years old, had cancer that led to transplant, and had at least one clinical posttransplant pain score of ≥3/10. Exclusion criteria included cognitive impairment (eg, dementia, psychosis) and inability to converse in English. Eligible health care providers were recruited through ABMT administrators and included nurse practitioners, physician's assistants, and registered nurses." 4a-i) Computer / Internet literacy Computer / Internet literacy is often an implicit "de facto" eligibility criterion -this should be explicitly clariUed.
Does your paper address subitem 4a-i?
Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briesy explain why the item is not applicable/relevant for your study Your answer subitem not at all important 1 2 3 4 5 essential 4a-ii) Open vs. closed, web-based vs. face-to-face assessments: Open vs. closed, web-based vs. face-to-face assessments: Mention how participants were recruited (online vs. orine), e.g., from an open access website or from a clinic, and clarify if this was a purely web-based trial, or there were face-to-face components (as part of the intervention or for assessment), i.e., to what degree got the study team to know the participant. In online-only trials, clarify if participants were quasi-anonymous and whether having multiple identities was possible or whether technical or logistical measures (e.g., cookies, email conUrmation, phone calls) were used to detect/prevent these.
Does your paper address subitem 4a-ii? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briesy explain why the item is not applicable/relevant for your study "All participants were recruited in person from the adult bone marrow transplant clinic (ABMT) at a major academic medical center. Self-report assessments were completed via the study website; the 2MWT was conducted at the medical center face-to-face with a research study team member." "Participants randomized to mPCST completed the Urst session in person at the medical center following their baseline study assessment and before discharge home. Participants who did not have Internet access to participate in videoconferencing and Web-based assessments from home or who desired to have study-provided hardware were loaned a tablet computer (ie, iPad) equipped with 3G Internet access; most participants elected to use the study-provided iPad to complete the intervention. Participants randomized to treatment as usual were also loaned a tablet computer as needed to complete assessments." subitem not at all important 1 2 3 4 5 essential 4b) Settings and locations where the data were collected 4a-iii) Information giving during recruitment Information given during recruitment. Specify how participants were briefed for recruitment and in the informed consent procedures (e.g., publish the informed consent documentation as appendix, see also item X26), as this information may have an effect on user self-selection, user expectation and may also bias results.
Does your paper address subitem 4a-iii?
Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briesy explain why the item is not applicable/relevant for your study Your answer Does your paper address CONSORT subitem 4b? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briesy explain why the item is not applicable/relevant for your study "Self-report assessments were completed via the study website; the 2MWT was conducted at the medical center." "Participants randomized to mPCST completed the Urst session in person at the medical center following their baseline study assessment before discharge home." subitem not at all important 1 2 3 4 5 essential subitem not at all important 1 2 3 4 5 essential 5) The interventions for each group with sufficient details to allow replication, including how and when they were actually administered 4b-i) Report if outcomes were (self-)assessed through online questionnaires Clearly report if outcomes were (self-)assessed through online questionnaires (as common in webbased trials) or otherwise.
Does your paper address subitem 4b-i? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briesy explain why the item is not applicable/relevant for your study "Self-report assessments were completed online via the study website; the 2MWT was conducted at the medical center with a research study team member." 4b-ii) Report how institutional ajliations are displayed Report how institutional ajliations are displayed to potential participants [on ehealth media], as ajliations with prestigious hospitals or universities may affect volunteer rates, use, and reactions with regards to an intervention.(Not a required item -describe only if this may bias results) Does your paper address subitem 4b-ii?
Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briesy explain why the item is not applicable/relevant for your study Does your paper address subitem 5-i?
Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briesy explain why the item is not applicable/relevant for your study Your answer 5-ii) Describe the history/development process Describe the history/development process of the application and previous formative evaluations (e.g., focus groups, usability testing), as these will have an impact on adoption/use rates and help with interpreting results.
Does your paper address subitem 5-ii?
Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briesy explain why the item is not applicable/relevant for your study

5-iii) Revisions and updating
Revisions and updating. Clearly mention the date and/or version number of the application/intervention (and comparator, if applicable) evaluated, or describe whether the intervention underwent major changes during the evaluation process, or whether the development and/or content was "frozen" during the trial. Describe dynamic components such as news feeds or changing content which may have an impact on the replicability of the intervention (for unexpected events see item 3b).
Does your paper address subitem 5-iii?
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5-iv) Quality assurance methods
Provide information on quality assurance methods to ensure accuracy and quality of information provided [1], if applicable.
Does your paper address subitem 5-iv?
Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briesy explain why the item is not applicable/relevant for your study Your answer subitem not at all important 1 2 3 4 5 essential subitem not at all important 1 2 3 4 5 essential 5-v) Ensure replicability by publishing the source code, and/or providing screenshots/screen-capture video, and/or providing sowcharts of the algorithms used Ensure replicability by publishing the source code, and/or providing screenshots/screen-capture video, and/or providing sowcharts of the algorithms used. Replicability (i.e., other researchers should in principle be able to replicate the study) is a hallmark of scientiUc reporting.
Does your paper address subitem 5-v?
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5-vi) Digital preservation
Digital preservation: Provide the URL of the application, but as the intervention is likely to change or disappear over the course of the years; also make sure the intervention is archived (Internet Archive, webcitation.org, and/or publishing the source code or screenshots/videos alongside the article). As pages behind login screens cannot be archived, consider creating demo pages which are accessible without login.
Does your paper address subitem 5-vi?
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5-vii) Access
Access: Describe how participants accessed the application, in what setting/context, if they had to pay (or were paid) or not, whether they had to be a member of speciUc group. If known, describe how participants obtained "access to the platform and Internet" [1]. To ensure access for editors/reviewers/readers, consider to provide a "backdoor" login account or demo mode for reviewers/readers to explore the application (also important for archiving purposes, see vi).
Does your paper address subitem 5-vii? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briesy explain why the item is not applicable/relevant for your study mPCST intervention participants accessed the study website from home and participated in video-conferencing sessions from home. They did not have to pay to access the study website. Participants were all set up with and account, including their own unique user ID and password, to access the study website and mobile health content. Does your paper address subitem 5-viii? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briesy explain why the item is not applicable/relevant for your study "An initial mPCST protocol was developed that was informed by the investigators' expertise in several areas including PCST protocol development, mHealth applications, and observational studies of pain and other symptoms in HCT patients. Focus groups and user testing were conducted to guide investigators in tailoring and reUning the mPCST protocol, intervention website, and participant materials to meet the unique needs of HCT patients with pain.
The intervention protocol, website, and participant materials were designed based on cognitive behavioral theory and social cognitive theory." "Patients are taught several skills (eg, relaxation training, cognitive-restructuring, activity pacing, pleasant activity planning, imagery, problem solving, and goal setting) to enhance their ability to cope with their pain by changing their thoughts, feelings, and behaviors. Sessions focus on reviewing content and skills practice from the previous session, learning a new skill, skill rehearsal, and home skills practice planning for the upcoming week." "The initial mPCST protocol we proposed included 6, 50-min sessions delivered over a period of 6-10 weeks. This protocol included several innovative features designed to address the unique challenges faced by HCT patients: it was brief, bridged the intensive outpatient (1 session) and home (5 sessions) settings, and used videoconferencing via an iPad for delivery in patients' homes. The initial mPCST session was designed to occur in-person in the medical center setting before discharge home to allow facilitation of a relationship between the therapist and patient, and to establish care that bridges intensive outpatient and home care. The subsequent 5 sessions were to be delivered to the patients in their home environment through the use of videoconferencing (iPad and Skype).
Videoconferencing (vs in-person and/or telephone delivery) provided the following important advantages: (1) it allowed patients who lived far from the medical center to engage in the intervention, (2) there is evidence that educational and psychosocial content is better communicated through videoconferencing than through telephone, and (3)  incorporate material from the session into daily life was also given to facilitate skill acquisition and generalization of skills use into their normal routine. Adherence was promoted by reviewing homework at the beginning of each session, developing action plans for skills use, and providing positive reinforcement. The study website provided patients with a place to have a daily connection with the mPCST intervention by recording their symptoms and skills use, accessing study materials, and receiving tailored feedback based on their daily assessment of skills practice."

5-ix) Describe use parameters
Describe use parameters (e.g., intended "doses" and optimal timing for use). Clarify what instructions or recommendations were given to the user, e.g., regarding timing, frequency, heaviness of use, if any, or was the intervention used ad libitum.
Does your paper address subitem 5-ix?
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5-x) Clarify the level of human involvement
Clarify the level of human involvement (care providers or health professionals, also technical assistance) in the e-intervention or as co-intervention (detail number and expertise of professionals involved, if any, as well as "type of assistance offered, the timing and frequency of the support, how it is initiated, and the medium by which the assistance is delivered". It may be necessary to distinguish between the level of human involvement required for the trial, and the level of human involvement required for a routine application outside of a RCT setting (discuss under item 21generalizability).
subitem not at all important 1 2 3 4 5 essential Does your paper address subitem 5-x?
Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briesy explain why the item is not applicable/relevant for your study Your answer 5-xi) Report any prompts/reminders used Report any prompts/reminders used: Clarify if there were prompts (letters, emails, phone calls, SMS) to use the application, what triggered them, frequency etc. It may be necessary to distinguish between the level of prompts/reminders required for the trial, and the level of prompts/reminders for a routine application outside of a RCT setting (discuss under item 21 -generalizability).
Does your paper address subitem 5-xi? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briesy explain why the item is not applicable/relevant for your study "One aspect of the website that was particularly popular with providers and participants was the Just for You feedback box designated for individualized therapist feedback for participants (See Figure 4)." The Just for You feedback box on the website included reminders/prompts/encouragement and overall personalized feedback.
Study therapists provided participants with reminders/prompts/encouragement to use the study website as well as the coping skills during each intervention session.
subitem not at all important 1 2 3 4 5 essential 6a) Completely defined pre-specified primary and secondary outcome measures, including how and when they were assessed 5-xii) Describe any co-interventions (incl. training/support) Describe any co-interventions (incl. training/support): Clearly state any interventions that are provided in addition to the targeted eHealth intervention, as ehealth intervention may not be designed as stand-alone intervention. This includes training sessions and support [1]. It may be necessary to distinguish between the level of training required for the trial, and the level of training for a routine application outside of a RCT setting (discuss under item 21 -generalizability. Does your paper address subitem 5-xii? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briesy explain why the item is not applicable/relevant for your study This item is not applicable/relevant for our study. A pilot RCT was conducted to examine the feasibility, acceptability, and initial ejcacy of the Unal mPCST protocol compared with a treatment as usual condition.
subitem not at all important 1 2 3 4 5 essential Does your paper address CONSORT subitem 6a? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briesy explain why the item is not applicable/relevant for your study "Feasibility was assessed by examining overall accrual, attrition, and adherence." "Acceptability was assessed with the client satisfaction questionnaire (CSQ), 10item version. CSQ was completed by participants in the mPCST intervention group at the post-treatment assessment. The measure was shown to have good reliability (Cronbach alpha=.96)." Initial ejcacy measures: "Pre-(before randomization) and postintervention assessments included measuring pain severity, pain disability, pain self-ejcacy, fatigue, and physical disability (ie, self-report, 2MWT). Self-report assessments were completed via the study website; the 2MWT was conducted at the medical center." 6a-i) Online questionnaires: describe if they were validated for online use and apply CHERRIES items to describe how the questionnaires were designed/deployed If outcomes were obtained through online questionnaires, describe if they were validated for online use and apply CHERRIES items to describe how the questionnaires were designed/deployed [9].
Does your paper address subitem 6a-i?

7b) When applicable, explanation of any interim analyses and stopping guidelines
Does your paper address CONSORT subitem 6b? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briesy explain why the item is not applicable/relevant for your study No, no changes to trial outcomes after the trial commenced.
7a-i) Describe whether and how expected attrition was taken into account when calculating the sample size Describe whether and how expected attrition was taken into account when calculating the sample size.
Does your paper address subitem 7a-i?
Copy and paste relevant sections from manuscript title (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briesy explain why the item is not applicable/relevant for your study Your answer 8a) Method used to generate the random allocation sequence NPT: When applicable, how care providers were allocated to each trial group 8b) Type of randomisation; details of any restriction (such as blocking and block size) Does your paper address CONSORT subitem 7b? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briesy explain why the item is not applicable/relevant for your study Not applicable.
Does your paper address CONSORT subitem 8a? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briesy explain why the item is not applicable/relevant for your study Patients were randomly assigned with a 1:1 allocation using a computer generated code. Randomization occurred automatically with randomization program.
Does your paper address CONSORT subitem 8b? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briesy explain why the item is not applicable/relevant for your study Patients were randomly assigned with a 1:1 allocation using a computer generated code. Randomization occurred automatically with randomization program. 9) Mechanism used to implement the random allocation sequence (such as sequentially numbered containers), describing any steps taken to conceal the sequence until interventions were assigned 10) Who generated the random allocation sequence, who enrolled participants, and who assigned participants to interventions 11a) If done, who was blinded after assignment to interventions (for example, participants, care providers, those assessing outcomes) and how NPT: Whether or not administering co-interventions were blinded to group assignment Does your paper address CONSORT subitem 9? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briesy explain why the item is not applicable/relevant for your study Randomization occurred automatically with the randomization program.
Does your paper address CONSORT subitem 10? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briesy explain why the item is not applicable/relevant for your study Our data manager oversaw randomization which occurred automatically with the randomization program. Our clinical research coordinators enrolled participants and assigned participants to their intervention group.
subitem not at all important 1 2 3 4 5 essential subitem not at all important 1 2 3 4 5 essential 11b) If relevant, description of the similarity of interventions (this item is usually not relevant for ehealth trials as it refers to similarity of a placebo or sham intervention to a active medication/intervention) 11a-i) Specify who was blinded, and who wasn't Specify who was blinded, and who wasn't. Usually, in web-based trials it is not possible to blind the participants [1, 3] (this should be clearly acknowledged), but it may be possible to blind outcome assessors, those doing data analysis or those administering co-interventions (if any).
Does your paper address subitem 11a-i? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briesy explain why the item is not applicable/relevant for your study Not applicable.
11a-ii) Discuss e.g., whether participants knew which intervention was the "intervention of interest" and which one was the "comparator" Informed consent procedures (4a-ii) can create biases and certain expectations -discuss e.g., whether participants knew which intervention was the "intervention of interest" and which one was the "comparator".
Does your paper address subitem 11a-ii?
Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briesy explain why the item is not applicable/relevant for your study Your answer 12a) Statistical methods used to compare groups for primary and secondary outcomes NPT: When applicable, details of whether and how the clustering by care providers or centers was addressed Does your paper address CONSORT subitem 11b? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briesy explain why the item is not applicable/relevant for your study Does your paper address CONSORT subitem 12a? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briesy explain why the item is not applicable/relevant for your study "Analytic Strategy Focus groups were audio-recorded and 2 group leaders took Ueld notes. Audio Ules were transcribed by a member of the research study team; a second team member performed a quality check by replaying the audio Ule and editing the transcript as needed. Grounded theory methods were used to evaluate the data gathered from the focus groups. Audio recordings were reviewed using open coding (ie, in vivo) and memoing by 3 members of the study team to generate repeated concepts. These results were categorized into 5 major themes through selective coding methods.
For RCT, descriptive statistics were calculated for demographic, medical, feasibility, study self-report variables (ie, acceptability, pain severity, pain disability, pain self-ejcacy, fatigue, and physical disability), and 2MWT. Analysis of variance (ANOVA), chi-square, or Fisher exact tests were used, as appropriate, to examine baseline differences between groups on medical and demographic variables. Outcome analyses were conducted using both an intent-to-treat approach (last value carried forward) and complete case analysis. The results of both the analytic strategies were comparable. Results using the complete case analysis approach are presented below. Paired t tests were used to examine within group differences from baseline to follow-up on study outcome variables (ie, pain severity, pain disability, self-ejcacy for pain management, fatigue, and physical disability). The magnitudes of the effect sizes were deUned according to standard convention for Cohen d (small=0.2, medium=0.5, large=0.8)." subitem not at all important 1 2 3 4 5 essential 12b) Methods for additional analyses, such as subgroup analyses and adjusted analyses 12a-i) Imputation techniques to deal with attrition / missing values Imputation techniques to deal with attrition / missing values: Not all participants will use the intervention/comparator as intended and attrition is typically high in ehealth trials. Specify how participants who did not use the application or dropped out from the trial were treated in the statistical analysis (a complete case analysis is strongly discouraged, and simple imputation techniques such as LOCF may also be problematic [4]).
Does your paper address subitem 12a-i? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briesy explain why the item is not applicable/relevant for your study "Outcome analyses were conducted using both an intent-to-treat approach (last value carried forward) and complete case analysis. The results of both the analytic strategies were comparable. Results using the complete case analysis approach are presented below." Our imputation technique was last-value carried forward, but there were no differences between this technique and complete-case analyses in terms or results.
Does your paper address CONSORT subitem 12b? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briesy explain why the item is not applicable/relevant for your study

RESULTS
13a) For each group, the numbers of participants who were randomly assigned, received intended treatment, and were analysed for the primary outcome NPT: The number of care providers or centers performing the intervention in each group and the number of patients treated by each care provider in each center X26-iii) Safety and security procedures Safety and security procedures, incl. privacy considerations, and any steps taken to reduce the likelihood or detection of harm (e.g., education and training, availability of a hotline) Does your paper address subitem X26-iii?
Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briesy explain why the item is not applicable/relevant for your study 13b) For each group, losses and exclusions after randomisation, together with reasons Does your paper address CONSORT subitem 13a? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briesy explain why the item is not applicable/relevant for your study "Ninety percent (36/40) of the intended participants were recruited during the proposed study timeframe. Of the 36 participants recruited, 92% completed the study (n=33). Of the 3 non completers, 2 were randomized to the intervention group and 1 was randomized to the control group. Reasons for noncompletion included patient illness and loss to follow-up. The Mann-Whitney U-test or Fisher exact test, whichever was appropriate, was used to determine if the baseline characteristics of noncompleters systematically differed from participants completing the study. There were no signiUcant differences in the baseline sociodemographic characteristics between individuals who completed the study and those who did not. However, noncompleters reported signiUcantly greater pain severity at baseline when compared with completers (M=6.17 vs 3.14; Mann-Whitney U=13.50, P=.03).
Out of all the patients accrued, 50% ( Does your paper address CONSORT subitem 13b? (NOTE: Preferably, this is shown in a CONSORT sow diagram) * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briesy explain why the item is not applicable/relevant for your study "The consort diagram for RCT is presented in Figure 5. Of the 3 non completers, 2 were randomized to the intervention group and 1 was randomized to the control group. Reasons for noncompletion included patient illness and loss to follow-up."

13b-i) Attrition diagram
Strongly recommended: An attrition diagram (e.g., proportion of participants still logging in or using the intervention/comparator in each group plotted over time, similar to a survival curve) or other Ugures or tables demonstrating usage/dose/engagement.

Does your paper address subitem 13b-i?
Copy and paste relevant sections from the manuscript or cite the Ugure number if applicable (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briesy explain why the item is not applicable/relevant for your study Your answer Does your paper address CONSORT subitem 14a? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briesy explain why the item is not applicable/relevant for your study This study was conducted from 09/10/13 to 08/31/15.
subitem not at all important 1 2 3 4 5 essential 14b) Why the trial ended or was stopped (early)

15) A table showing baseline demographic and clinical characteristics for each group
NPT: When applicable, a description of care providers (case volume, qualiUcation, expertise, etc.) and centers (volume) in each group 14a-i) Indicate if critical "secular events" fell into the study period Indicate if critical "secular events" fell into the study period, e.g., signiUcant changes in Internet resources available or "changes in computer hardware or Internet delivery resources" Does your paper address subitem 14a-i?
Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briesy explain why the item is not applicable/relevant for your study Your answer Does your paper address CONSORT subitem 14b? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briesy explain why the item is not applicable/relevant for your study The study was not stopped early. The trial ended when we completed our recruitment goal which coincided with the end of the grant award period.
Does your paper address CONSORT subitem 15? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briesy explain why the item is not applicable/relevant for your study "Focus Groups and User Testing Participants included 32 individuals with HCT pain who had undergone autologous (87%; n=28/32) or allogeneic (13%; n=4/32) stem cell transplant and reported having post-transplant pain. Participants were 50% female (n=16/32), 72% Caucasian (n=23/32), and were aged between 43 and 76 years (M=61).
Majority of the participants were married (84%; n=27/32) and 53% (n=17/32) had a college degree or higher. Participants were on average 20 (SD=14) months post-transplant. The provider intervention evaluation focus group consisted of 10 providers, all of whom were females and held a position within nursing care for HCT patients (5 nurses practitioners, 2 clinical nurse specialists, 1 registered nurse, 1 outpatient clinic nurse manager, and 1 clinical research nurse)."

"Pilot Randomized Controlled Trial Results
The pilot RCT participants (n=36; different than all previous participants) were on average 56 (SD=12) years old and 50% female (n=18/36 16) For each group, number of participants (denominator) included in each analysis and whether the analysis was by original assigned groups Does your paper address subitem 15-i? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briesy explain why the item is not applicable/relevant for your study "Focus Groups and User Testing Participants included 32 individuals with HCT pain who had undergone autologous (87%; n=28/32) or allogeneic (13%; n=4/32) stem cell transplant and reported having post-transplant pain. Participants were 50% female (n=16/32), 72% Caucasian (n=23/32), and were aged between 43 and 76 years (M=61). Majority of the participants were married (84%; n=27/32) and 53% (n=17/32) had a college degree or higher. Participants were on average 20 (SD=14) months post-transplant. The provider intervention evaluation focus group consisted of 10 providers, all of whom were females and held a position within nursing care for HCT patients (5 nurses practitioners, 2 clinical nurse specialists, 1 registered nurse, 1 outpatient clinic nurse manager, and 1 clinical research nurse)."
Participants reported 1 other medical comorbidity, on average, with hypertension (28%; n=10/36), osteoarthritis (14%; n=5/36), diabetes (11%; n=4/36), and sciatica (11%; n=4/36) being the most common. There were no signiUcant differences in medical or sociodemographic variables by the treatment group." subitem not at all important 1 2 3 4 5 essential subitem not at all important 1 2 3 4 5 essential 16-i) Report multiple "denominators" and provide deUnitions Report multiple "denominators" and provide deUnitions: Report N's (and effect sizes) "across a range of study participation [and use] thresholds" [1], e.g., N exposed, N consented, N used more than x times, N used more than y weeks, N participants "used" the intervention/comparator at speciUc pre-deUned time points of interest (in absolute and relative numbers per group). Always clearly deUne "use" of the intervention.
Does your paper address subitem 16-i? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briesy explain why the item is not applicable/relevant for your study "Ninety percent (36/40) of the intended participants were recruited during the proposed study timeframe. Of the 36 participants recruited, 92% completed the study (n=33). Out of all the patients accrued, 50% (18/36) were randomized to the intervention group. 50% (18/36) were randomized to the treatment as usual group." Taking into account drop-outs, 16 intervention participants were included in analyses and 17 control group participants were included.
Yes, analyses were done by original assigned groups.

16-ii) Primary analysis should be intent-to-treat
Primary analysis should be intent-to-treat, secondary analyses could include comparing only "users", with the appropriate caveats that this is no longer a randomized sample (see 18-i).
17a) For each primary and secondary outcome, results for each group, and the estimated effect size and its precision (such as 95% confidence interval) Does your paper address subitem 16-ii?
Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briesy explain why the item is not applicable/relevant for your study Your answer Does your paper address CONSORT subitem 17a? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briesy explain why the item is not applicable/relevant for your study See Table 2 for complete comparative pre-and post intervention data, including the estimated effect size and its precision (such as 95% conUdence interval).
At baseline, there were no signiUcant differences in outcome variables (ie, pain severity, pain disability, pain self-ejcacy, fatigue, and physical disability [ie, selfreport, 2MWT]) between randomization groups. Within-group comparisons from baseline to postintervention are presented in Table 2. Individuals in the intervention group saw improvements in all variables of interest. The pattern of effect sizes suggests that individuals in the intervention group showed greater improvements in pain disability (d=0.79 vs 0.69), pain self-ejcacy (d=0.61 vs 0.10), fatigue (d=0.94 vs 0.81), and on the 2MWT (d=0.66 vs 0.41), an objective assessment of physical disability. Although differences between the outcomes are fairly subtle, the largest relative difference between the intervention and control groups appears to be for pain self-ejcacy, which is a natural intermediate outcome that the intervention was designed to address directly. The magnitude of the effect sizes was greater for the control group with regard to self-reported physical disability and pain severity; however, both groups evidenced large and small-to-medium effect sizes, respectively, on these variables." subitem not at all important 1 2 3 4 5 essential 17b) For binary outcomes, presentation of both absolute and relative effect sizes is recommended 17a-i) Presentation of process outcomes such as metrics of use and intensity of use In addition to primary/secondary (clinical) outcomes, the presentation of process outcomes such as metrics of use and intensity of use (dose, exposure) and their operational deUnitions is critical. This does not only refer to metrics of attrition (13-b) (often a binary variable), but also to more continuous exposure metrics such as "average session length". These must be accompanied by a technical description how a metric like a "session" is deUned (e.g., timeout after idle time) [1] (report under item 6a).
Does your paper address subitem 17a-i?
Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briesy explain why the item is not applicable/relevant for your study 18) Results of any other analyses performed, including subgroup analyses and adjusted analyses, distinguishing pre-specified from exploratory subitem not at all important 1 2 3 4 5 essential Does your paper address CONSORT subitem 17b? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briesy explain why the item is not applicable/relevant for your study "The pattern of effect sizes suggests that individuals in the intervention group showed greater improvements in pain disability (d=0.79 vs 0.69), pain selfejcacy (d=0.61 vs 0.10), fatigue (d=0.94 vs 0.81), and on the 2MWT (d=0.66 vs 0.41), an objective assessment of physical disability. Although differences between the outcomes are fairly subtle, the largest relative difference between the intervention and control groups appears to be for pain self-ejcacy, which is a natural intermediate outcome that the intervention was designed to address directly. The magnitude of the effect sizes was greater for the control group with regard to self-reported physical disability and pain severity; however, both groups evidenced large and small-to-medium effect sizes, respectively, on these variables." Does your paper address CONSORT subitem 18? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briesy explain why the item is not applicable/relevant for your study Not applicable.

18-i) Subgroup analysis of comparing only users
A subgroup analysis of comparing only users is not uncommon in ehealth trials, but if done, it must be stressed that this is a self-selected sample and no longer an unbiased sample from a randomized trial (see 16-iii). Does your paper address subitem 19-ii?

19) All important harms or unintended effects in each group
Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briesy explain why the item is not applicable/relevant for your study Your answer 22-i) Restate study questions and summarize the answers suggested by the data, starting with primary outcomes and process outcomes (use) Restate study questions and summarize the answers suggested by the data, starting with primary outcomes and process outcomes (use).
Does your paper address subitem 22-i? * Does your paper address subitem 22-i? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briesy explain why the item is not applicable/relevant for your study "Study Objectives The objective of this line of research was to develop a mobile health pain coping skills training (mPCST) protocol, designed to address the speciUc pain and psychosocial challenges of HCT patients. We used an iterative development model to design the protocol; methods from grounded theory were followed [22]. First, we developed an initial mPCST intervention for HCT patients using our study team's expertise and experience in Pain Coping Skills Training (PCST), cognitive-behavioral pain interventions, mobile health technology, and the treatment of HCT. We then conducted focus groups with both HCT patients and providers to reUne and adapt the intervention. Following this, the enhanced intervention was delivered to a separate small group of patients who completed user testing. Qualitative data gathered from each stage of development were used to inform the subsequent modiUcation of the intervention.
A pilot randomized controlled trial (RCT) was conducted to examine the feasibility, acceptability, and initial ejcacy of the Unal mPCST protocol. The Urst aim of the pilot RCT was to show that the mPCST protocol would be feasible (ie, accrual, attrition, and adherence) and acceptable. The second aim was to examine the initial ejcacy of the mPCST protocol (compared with a treatment as the usual condition) on pain severity, pain disability, pain self-ejcacy, fatigue, and physical disability (ie, self-report and 2-min walk test [2MWT]).

Pilot Randomized Controlled Trial Results
Feasibility & Acceptability: Ninety percent (36/40) of the intended participants were recruited during the proposed study timeframe. Of the 36 participants recruited, 92% completed the study (n=33). Of the 3 non completers, 2 were randomized to the intervention group and 1 was randomized to the control group. Reasons for noncompletion included patient illness and loss to follow-up. The Mann-Whitney U-test or Fisher exact test, whichever was appropriate, was used to determine if the baseline characteristics of noncompleters systematically differed from participants completing the study. There were no signiUcant differences in the baseline sociodemographic characteristics between individuals who completed the study and those who did not. However, noncompleters reported signiUcantly greater pain severity at baseline when compared with completers (M=6.17 vs 3.14; Mann-Whitney U=13.50, P=.03).
Out of all the patients accrued, 50% (18/36) were randomized to the intervention group. Patients in the intervention group completed an average of 5 of the 6 sessions offered to them. A total of 14 participants completed all 6 sessions (1 in-person and 5 via videoconferencing); on average, these participants completed the intervention in 34 days (SD=5). Following the Unal session, 85% of participants reported using the skills they had learned on several days of the week. Participants reported the sessions to be helpful (M=8/10), easy to understand (M=7/7), and highly acceptable (M=4/4). Overall, 75% participants rated the intervention as excellent and 25% rated it as good.
Initial Ejcacy: At baseline, there were no signiUcant differences in outcome variables (ie, pain severity, pain disability, pain self-ejcacy, fatigue, and physical disability [ie, selfreport, 2MWT]) between randomization groups. Within-group comparisons from baseline to postintervention are presented in Table 2. Individuals in the intervention group saw improvements in all variables of interest. The pattern of effect sizes suggests that individuals in the intervention group showed greater improvements in pain disability (d=0.79 vs 0.69), pain self-ejcacy (d=0.61 vs 0.10), fatigue (d=0.94 vs 0.81), and on the 2MWT (d=0.66 vs 0.41), an objective assessment of physical disability. Although differences between the outcomes are fairly subtle, the largest relative difference between the intervention and control groups appears to be for pain self-ejcacy, which is a natural intermediate outcome that the intervention was designed to address directly.
The magnitude of the effect sizes was greater for the control group with regard to self-reported physical disability and pain severity; however, both groups evidenced large and small-to-medium effect sizes, respectively, on these variables.
Our pilot RCT found that the developed intervention was highly feasible and acceptable to HCT patients with pain. Preliminary data suggest that the developed mPCST intervention likely improves patients' abilities to manage their pain (ie, pain self-ejcacy), decrease pain-related disability, and decrease symptoms of fatigue." Does your paper address subitem 22-ii?
Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briesy explain why the item is not applicable/relevant for your study Your answer

20-i) Typical limitations in ehealth trials
Typical limitations in ehealth trials: Participants in ehealth trials are rarely blinded. Ehealth trials often look at a multiplicity of outcomes, increasing risk for a Type I error. Discuss biases due to non-use of the intervention/usability issues, biases through informed consent procedures, unexpected events.

21) Generalisability (external validity, applicability) of the trial findings
NPT: External validity of the trial Undings according to the intervention, comparators, patients, and care providers or centers involved in the trial subitem not at all important 1 2 3 4 5 essential Does your paper address subitem 20-i? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briesy explain why the item is not applicable/relevant for your study "This study has several limitations. First, this work was completed through the use of iPads, which require either a data plan or Internet connection to be able to videoconference with the therapist. The intervention itself is scalable for use on either a personal computer or mobile phone; the number of individual's access to a personal computer, tablet, or mobile phone is greater than 50%, and future work should be designed to be inclusive of all possible technology devices. Second, the RCT was relatively small (N=36), conducted in a single medical center, and had a short follow-up period; future work should expand the study size, consider using multiple sites, and examine longer term outcomes."

21-i) Generalizability to other populations
Generalizability to other populations: In particular, discuss generalizability to a general Internet population, outside of a RCT setting, and general patient population, including applicability of the study results for other organizations Does your paper address subitem 21-i?
Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briesy explain why the item is not applicable/relevant for your study Discuss if there were elements in the RCT that would be different in a routine application setting (e.g., prompts/reminders, more human involvement, training sessions or other co-interventions) and what impact the omission of these elements could have on use, adoption, or outcomes if the intervention is applied outside of a RCT setting.
Does your paper address subitem 21-ii?
Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briesy explain why the item is not applicable/relevant for your study Your answer Does your paper address CONSORT subitem 23? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briesy explain why the item is not applicable/relevant for your study Does your paper address CONSORT subitem 24? * Cite a Multimedia Appendix, other reference, or copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briesy explain why the item is not applicable/relevant for your study The full trial protocol is not available. Clinicaltrials.gov has a summary of the trial protocol.
Does your paper address CONSORT subitem 25? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briesy explain why the item is not applicable/relevant for your study "Funding for this project (Grant Number: 1R21CA173307-01A1) was provided by National Institute of Health (NIH) to Tamara J. Somers, PhD." X27-i) State the relation of the study team towards the system being evaluated In addition to the usual declaration of interests (Unancial or otherwise), also state the relation of the study team towards the system being evaluated, i.e., state if the authors/evaluators are distinct from or identical with the developers/sponsors of the intervention.