Smartphone-Based Psychotherapeutic Interventions in Blended Care of Cancer Survivors: Nested Randomized Clinical Trial

Background Cancer is related to not only physical but also mental suffering. Notably, body image disturbances are highly relevant to cancer-related changes often persisting beyond recovery from cancer. Scalable and low-barrier interventions that can be blended with face-to-face psychotherapy for cancer survivors are highly warranted. Objective The aim of the study is to investigate whether smartphone-based bodily interventions are more effective to improve the mood of patients with cancer than smartphone-based fairy tale interventions (control intervention). Methods We recruited patients with cancer in 2 Swiss hospitals and conducted daily, fully automated smartphone-based interventions 6 times a week for 5 consecutive weeks, blended with weekly face-to-face group body psychotherapy. We applied 2 types of smartphone-based interventions using a within-subject design, randomly assigning patients daily to either bodily interventions or fairy tales. Each intervention type was presented 3 times a week. For this secondary analysis, 3-level mixed models were estimated with mood assessed by the 3 Multidimensional Mood Questionnaire subscales for good-bad mood, wakefulness, and calmness as key indicators. In addition, the effects on experience of presence, vitality, and burden assessed with visual analog scales were investigated. Results Based on the data from s=732 interventions performed by 36 participants, good-bad mood improved (β=.27; 95% CI 0.062-0.483), and participants became calmer (β=.98; 95% CI 0.740-1.211) following smartphone-based interventions. Wakefulness did not significantly change from pre- to postsmartphone–based intervention (β=.17; 95% CI –0.081 to 0.412). This was true for both intervention types. There was no interaction effect of intervention type with change in good-bad mood (β=–.01; 95% CI –0.439 to 0.417), calmness (β=.22; 95% CI –0.228 to 0.728), or wakefulness (β=.14; 95% CI –0.354 to 0.644). Experience of presence (β=.34; 95% CI 0.271-0.417) and vitality (β=.35; 95% CI 0.268-0.426) increased from pre- to postsmartphone–based intervention, while experience of burden decreased (β=–0.40; 95% CI –0.481 to 0.311). Again, these effects were present for both intervention types. There were no significant interaction effects of intervention type with pre- to postintervention changes in experience of presence (β=.14; 95% CI –0.104 to 0.384), experience of vitality (β=.06; 95% CI –0.152 to 0.265), and experience of burden (β=–.16; 95% CI –0.358 to 0.017). Conclusions Our results suggest that both smartphone-based audio-guided bodily interventions and fairy tales have the potential to improve the mood of cancer survivors. Trial Registration ClinicalTrials.gov NCT03707548; https://clinicaltrials.gov/study/NCT03707548 International Registered Report Identifier (IRRID) RR2-10.1186/s40359-019-0357-1

Manuscript tracking number * If this is a JMIR submission, please provide the manuscript tracking number under "other" (The ms tracking number can be found in the submission acknowledgement email, or when you login as author in JMIR. If the paper is already published in JMIR, then the ms tracking number is the four-digit number at the end of the DOI, to be found at the bottom of each published article in JMIR) 1a) Does your paper address CONSORT item 1a? * I.e does the title contain the phrase "Randomized Controlled Trial"? (if not, explain the reason under "other") instead of "randomized controlled trial" we used "randomized clinical trial" as w 05.04.22,

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 offline 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.

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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 briefly explain why the item is not applicable/relevant for your study "Smartphone-Based Digital Interventions"

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 briefly explain why the item is not applicable/relevant for your study Meine Antwort 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

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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 briefly explain why the item is not applicable/relevant for your study Our target group was "Cancer Survivors" (post-treatment cancer patients)

1b-i) Key features/functionalities/components of the intervention and comparator in the METHODS section of the ABSTRACT
Mention key features/functionalities/components of the intervention and comparator in the abstract. If possible, also mention theories and principles used for designing the site. Keep in mind the needs of systematic reviewers and indexers by including important synonyms. (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)

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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 briefly explain why the item is not applicable/relevant for your study "(...) conducted daily, fully automated smartphone-based interventions six times a week for five consecutive weeks, blended with weekly face-to-face group psychotherapy. We applied two types of smartphone-based interventions, using a within-subject design, randomly assigning patients daily to either bodily interventions or to fairy tales."

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) 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 briefly explain why the item is not applicable/relevant for your study "(...) conducted daily, fully automated smartphone-based interventions six times a week for five consecutive weeks, blended with weekly face-to-face group psychotherapy." 1b-iii) Open vs. closed, web-based (self-assessment) vs. face-to-face assessments in the METHODS section of the ABSTRACT Mention how participants were recruited (online vs. offline), 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
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 briefly explain why the item is not applicable/relevant for your study "(...) conducted daily, fully automated smartphone-based interventions six times a week for five consecutive weeks, blended with weekly face-to-face group psychotherapy." https://docs.google.com/forms/d/e/1FAIpQLSfZBSUp1bwOc_Oim…&formkey=dGlKd2Z2Q1lNSGQ0THl1azM5MS1aWWc6MA&rm=full#gid=0 subitem not at all important 1 2 3 4 5 essential 1b-iv) RESULTS section in abstract must contain use data Report number of participants enrolled/assessed in each group, the use/uptake of the intervention (e.g., attrition/adherence metrics, use over time, number of logins etc.), in addition to primary/secondary outcomes. (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)
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 briefly explain why the item is not applicable/relevant for your study

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Does your paper address subitem 1b-v?
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 briefly explain why the item is not applicable/relevant for your study

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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 briefly explain why the item is not applicable/relevant for your study "Mobile mental health has become a topic of considerable interest for cancer patients to promote self-management of their chronic disease [8]. Previous studies indicated that smartphone-based interventions have the potential to reduce symptoms of mental disorders, such as anxiety and depression [9,10]. Notably, smartphone-based interventions allow supporting patients in their daily lives, thereby reducing personal and economic costs of mental health problems [11]. Also, in the field of cancer treatment, there is an increasing focus on the development of technological at-home interventions that aim to improve health outcomes [12]. Furthermore, there is evidence that online interventions can be successfully blended with face-to-face psychotherapy [13] and that the use of mobile technology can increase the effectiveness of psychotherapeutic interventions [14]. Yet, the effects of smartphone-based interventions embedded in a psychotherapeutic context as blended psychotherapy for cancer survivors remain to be elucidated. Hence, we set out to complement group body psychotherapy by daily smartphone-based digital interventions, aiming at investigating whether these had short-term effects on patients' mood. We provided digital interventions based on daily randomization: either providing an intervention specifically addressing bodily perceptions, consisting of bodily interventions, or providing an unspecific intervention, consisting of fairy tales, as comparator." METHODS 3a) Description of trial design (such as parallel, factorial) including allocation ratio 3b) Important changes to methods after trial commencement (such as eligibility criteria), with reasons 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 briefly explain why the item is not applicable/relevant for your study "The goal of this randomized trial was to explore changes in mood from pre-to postsmartphone-based intervention. We hypothesized that the mood of cancer survivors improves from pre-to post-intervention. Furthermore, we expected that mood improvement is greater, following bodily interventions as compared to fairy tales." 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 briefly explain why the item is not applicable/relevant for your study "Presented data originates from a nested randomized controlled trial, embedded in a nonrandomized study registered in ClinicalTrials.gov (NCT03707548)." We did not make important changes to methods after trial commencement.

3b-i) Bug fixes, Downtimes, Content Changes
Bug fixes, 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 fixes or changes in the functionality or content) (5-iii) and other "unexpected events" that may have influenced study design such as staff changes, system failures/downtimes, etc. [2].

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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 briefly explain why the item is not applicable/relevant for your study 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 briefly explain why the item is not applicable/relevant for your study "Inclusion criteria for this study were: (i) age ≥ 18 years, (ii) sufficient knowledge of spoken German, (iii) having received curatively intended treatment for any malignant neoplasm, (iv) suffering from bodily disturbances, (v) primary treatment being completed at least 3 months prior to recruitment, (vi) an Eastern Cooperative Oncology Group (ECOG) performance score of 0-1 [16], (vii) an anticipated life expectancy of ≥ 12 months, and (vii) the anticipated capacity to participate in 6 group BPT sessions, 2 study assessments, and the smartphonebased interventions. For the participation in the smartphone-based parts of the study, patients were required to own a smartphone and to be able to access their email account through it. Exclusion criteria were (i) sign of progress or recurrence of malignancy at study inclusion, (ii) suffering from a severe current mental disorder, (iii) risk of current suicidality, (iv) participation in any other clinical trial with a psychosocial intervention, (v) receiving any other current psychotherapeutic treatment (with the exception of already existing therapies lasting ≥ 6 months), and (vi) inability to understand and speak German. All eligibility criteria are described in detail in the study protocol [15]. Patients were recruited at the study centres; additionally, they were approached via public advertisements."

4a-i) Computer / Internet literacy
Computer / Internet literacy is often an implicit "de facto" eligibility criterion -this should be explicitly clarified. Does your paper address subitem 4a-i?

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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 briefly explain why the item is not applicable/relevant for your study "Third, smartphone-based interventions were designed to be very intuitive and straightforward to use, not requiring high internet or smartphone literacy of patients, further facilitating uptake of the technology." 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. offline), e.g., from an open access website or from a clinic, and clarify if this was a purely webbased 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 confirmation, 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 briefly explain why the item is not applicable/relevant for your study "We recruited cancer patients at hospitals and conducted daily, fully automated smartphone-based interventions six times a week for five consecutive weeks, blended with weekly face-to-face group psychotherapy."

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.
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 briefly explain why the item is not applicable/relevant for your study The informed consent is available on request.
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 briefly explain why the item is not applicable/relevant for your study "We used online software Questback [17] to conduct the smartphone-based interventions, including instructions, presentation of the audio-clips, collection of the questionnaire data, and sending the invitational emails."

4b-i) Report if outcomes were (self-)assessed through online questionnaires
Clearly report if outcomes were (self-)assessed through online questionnaires (as common in web-based trials) or otherwise.

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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 briefly explain why the item is not applicable/relevant for your study "We assessed mood pre-and post-smartphone-based interventions via online questionnaires." (...) "The MDMQ is a well-established tool for the self-assessment of current mood, especially suited for repeated measures with short intervals, which has previously been successfully applied within the context of smartphone-based micro interventions [20]." (...) "Additionally, we applied three single item visual analogue scales (VAS) to self-assess experience of presence, vitality, and burden (e.g., How present do you feel right now? VAS ranging from 0="not at all" to 10="extremely strong")."

4b-ii) Report how institutional affiliations are displayed
Report how institutional affiliations are displayed to potential participants [on ehealth media], as affiliations 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) 5) The interventions for each group with sufficient details to allow replication, including how and when they were actually administered subitem not at all important 1 2 3 4 5 essential 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 briefly explain why the item is not applicable/relevant for your study Meine Antwort

5-i) Mention names, credential, affiliations of the developers, sponsors, and owners
Mention names, credential, affiliations of the developers, sponsors, and owners [6] (if authors/evaluators are owners or developer of the software, this needs to be declared in a "Conflict of interest" section or mentioned elsewhere in the manuscript).

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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 briefly explain why the item is not applicable/relevant for your study "We used online software Questback [17] to conduct the smartphone-based interventions, including instructions, presentation of the audio-clips, collection of the questionnaire data, and sending the invitational emails."

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.

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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 briefly explain why the item is not applicable/relevant for your study Not relevant for our study, as we only used an online survey tool to play audio-clips as an intervention.

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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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 briefly explain why the item is not applicable/relevant for your study Not relevant for our study, as we only used an online survey tool to play audio-clips as an intervention.

5-iv) Quality assurance methods
Provide information on quality assurance methods to ensure accuracy and quality of information provided [1], if applicable.
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 briefly explain why the item is not applicable/relevant for your study Not relevant for our study, as we only used an online survey tool to play audio-clips as an intervention.

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Does your paper address subitem 5-v?
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 briefly explain why the item is not applicable/relevant for your study Not relevant for our study, as we only used an online survey tool to play audio-clips as an intervention.

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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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 briefly explain why the item is not applicable/relevant for your study Not relevant for our study, as we only used an online survey tool to play audio-clips as an intervention.

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 specific 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).

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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 briefly explain why the item is not applicable/relevant for your study "Patients could freely choose the time of day they participated in the digital intervention. The time window started each day at 07.00h with the invitational email including the dayspecific hyperlink giving access to the intervention. This hyperlink expired at midnight of the same day. We used online software Questback [17] to conduct the smartphone-based interventions, including instructions, presentation of the audio-clips, collection of the questionnaire data, and sending the invitational emails." This intervention was free of charge for patients who were registered as study participants.

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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 briefly explain why the item is not applicable/relevant for your study "The detailed procedure of each smartphone-based intervention was as follows: (i) Participants used their own smartphones to get connected via Internet browser to the Questback server, using a day-specific personalized hyperlink provided in the daily invitational email. We instructed patients to log into their email once a day. (ii) We asked patients to enter their individual self-generated personal code, which allowed verifying subject identity. (iii) Participants replied to a questionnaire described in more detail below.
(iv) In order to start the session, patients were asked to click on the "play" button of the audio player.

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.
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 briefly explain why the item is not applicable/relevant for your study "Over the course of five consecutive weeks, participants were randomly assigned daily to either the bodily or fairy tale intervention."

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 21 -generalizability). Does your paper address subitem 5-x?

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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 briefly explain why the item is not applicable/relevant for your study "We recruited cancer patients at hospitals and conducted daily, fully automated smartphone-based interventions six times a week for five consecutive weeks, blended with weekly face-to-face group psychotherapy."

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).

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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 briefly explain why the item is not applicable/relevant for your study "The time window started each day at 07.00h with the invitational email including the dayspecific hyperlink giving access to the intervention." We did not implement any reminders.

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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 briefly explain why the item is not applicable/relevant for your study "We formed seven face-to-face psychotherapy groups, consisting of 5 to 7 patients each."

6a-ii) Describe whether and how "use" (including intensity of use/dosage) was defined/measured/monitored
Describe whether and how "use" (including intensity of use/dosage) was defined/measured/monitored (logins, logfile analysis, etc.). Use/adoption metrics are important process outcomes that should be reported in any ehealth trial.

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Does your paper address subitem 6a-ii?
Copy and paste relevant sections from manuscript text "These patients participated in 65.5% of the smartphone-based bodily interventions (n=354/540) and in 70% of the smartphone-based control interventions (n=378/540)." 6a-iii) Describe whether, how, and when qualitative feedback from participants was obtained Describe whether, how, and when qualitative feedback from participants was obtained (e.g., through emails, feedback forms, interviews, focus groups).

Does your paper address subitem 6a-iii?
Copy and paste relevant sections from manuscript text Meine Antwort 6b) Any changes to trial outcomes after the trial commenced, with reasons 7a) How sample size was determined NPT: When applicable, details of whether and how the clustering by care provides or centers was addressed subitem not at all important 1 2 3 4 5 essential 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 briefly explain why the item is not applicable/relevant for your study Item is not applicable: 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 briefly explain why the item is not applicable/relevant for your study 05.04.22, 14:54 CONSORT-EHEALTH (V 1.6.1) -Submission/Publication Form Seite 36 von 62 https://docs.google.com/forms/d/e/1FAIpQLSfZBSUp1bwOc_Oim…&formkey=dGlKd2Z2Q1lNSGQ0THl1azM5MS1aWWc6MA&rm=full#gid=0 7b) When applicable, explanation of any interim analyses and stopping guidelines 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 briefly explain why the item is not applicable/relevant for your study no interim analyses and stopping guidelines applied 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 briefly explain why the item is not applicable/relevant for your study "We applied two types of smartphone-based interventions, using a within-subject design. Over the course of five consecutive weeks, participants were randomly assigned daily to either the bodily or fairy tale intervention." 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 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 briefly explain why the item is not applicable/relevant for your study "We applied two types of smartphone-based interventions, using a within-subject design, randomly assigning patients daily to either bodily interventions or to fairy tales. Each intervention type was presented three times a week." 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 briefly explain why the item is not applicable/relevant for your study "The Clinical Trial Unit of the University Hospital Basel independently generated the random sequences, using the software R, applying a block-design to ensure that each patient received both interventions three times a week." 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 subitem not at all important 1 2 3 4 5 essential 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 briefly explain why the item is not applicable/relevant for your study "The Clinical Trial Unit of the University Hospital Basel independently generated the random sequences, using the software R, applying a block-design to ensure that each patient received both interventions three times a week."

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).

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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 briefly explain why the item is not applicable/relevant for your study "Trial participants were blinded to randomization up until the moment at which the intervention was provided; body psychotherapists were also blinded to randomization." Data analysts where not blinded. 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 briefly explain why the item is not applicable/relevant for your study "Furthermore, we could not blind participants with regard to the intervention. Hence, it is possible that patients were aware of what was the intervention of interest (bodily intervention) and what was the comparator (fairy tales). This may have resulted in biased mood assessments pre-and post-smartphone-based interventions. Nevertheless, we did not inform patients that the overall goal of the smartphone-based interventions was to compare the effects of bodily interventions with that of fairy tales on mood." 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 briefly explain why the item is not applicable/relevant for your study "Both types of interventions lasted about 10 minutes each." Both interventions were delivered as audio-clips and matched in length.
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 subitem not at all important 1 2 3 4 5 essential 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 briefly explain why the item is not applicable/relevant for your study "Hence, as we were interested in the effect of two different smartphone-based interventions (Level 2) on mood changes in cancer survivors from pre-to post-intervention, we applied mixed models as indicated in Figure 1." (...) "Further, main effect models included assessment time (pre-vs. post-smartphone-based intervention) as independent variable and interventions nested within individual participants as random intercepts."

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 briefly explain why the item is not applicable/relevant for your study "We excluded subjects that did not participate in the smartphone-based part of the study and handled further missing data by applying mixed models with maximum likelihood estimation." 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 briefly explain why the item is not applicable/relevant for your study We did not conduct subgroup analyses and adjusted analyses.

Does your paper address subitem X26-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 briefly explain why the item is not applicable/relevant for your study Meine Antwort

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)

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 13b) For each group, losses and exclusions after randomisation, together with reasons 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 briefly explain why the item is not applicable/relevant for your study

Meine Antwort
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 briefly explain why the item is not applicable/relevant for your study "We screened 171 patients, of whom 40 were scheduled to take part in the face-to-face group body psychotherapy (see Flow Chart, Figure 2). Thirty-nine of these patients met the inclusion criteria; one patient was included incorrectly. " (...) "Therefore, the results of the smartphone-based interventions are based on data from 36 participants." 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 briefly explain why the item is not applicable/relevant for your study "We formed seven face-to-face psychotherapy groups, consisting of 5 to 7 patients each. Of the 40 patients scheduled to take part in the face-to-face group psychotherapy interventions of the larger non-randomized study, four did not participate in the smartphone-based interventions conducted with the here reported nested randomized controlled trial. One of the non-participants was the patient who had been included by mistake, two were drop out patients, and one patient took part in the group sessions but did not participate in the digital smartphone interventions. Another patient could not participate in the group sessions, but agreed to take part in the smartphone-based intervention."

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 figures or tables demonstrating usage/dose/engagement.

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Does your paper address subitem 13b-i?
Copy and paste relevant sections from the manuscript or cite the figure 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 briefly explain why the item is not applicable/relevant for your study 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 briefly explain why the item is not applicable/relevant for your study "We recruited patients between September 3, 2018 and May 12, 2019 in two Swiss hospitals (University Hospital Basel and Cantonal Hospital Winterthur). "

14a-i) Indicate if critical "secular events" fell into the study period
Indicate if critical "secular events" fell into the study period, e.g., significant changes in Internet resources available or "changes in computer hardware or Internet delivery resources"

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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 briefly explain why the item is not applicable/relevant for your study 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 briefly explain why the item is not applicable/relevant for your study Our trial was not stopped early.
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 briefly explain why the item is not applicable/relevant for your study " Table 1 presents the sociodemographic and cancer-related characteristics of all patients participating in the nested randomized controlled trial, receiving the smartphone-based interventions."

15-i) Report demographics associated with digital divide issues
In ehealth trials it is particularly important to report demographics associated with digital divide issues, such as age, education, gender, social-economic status, computer/Internet/ehealth literacy of the participants, if known. 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 briefly explain why the item is not applicable/relevant for your study " Table 1 presents the sociodemographic and cancer-related characteristics of all patients participating in the nested randomized controlled trial, receiving the smartphone-based interventions." Our smartphone-based interventions were designed to be very intuitive and straightforward to use, not requiring high internet or smartphone literacy of patients.

16-i) Report multiple "denominators" and provide definitions
Report multiple "denominators" and provide definitions: 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 specific pre-defined time points of interest (in absolute and relative numbers per group). Always clearly define "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 briefly explain why the item is not applicable/relevant for your study "We screened 171 patients, of whom 40 were scheduled to take part in the face-to-face group body psychotherapy (see Flow Chart, Figure 2). " https://docs.google.com/forms/d/e/1FAIpQLSfZBSUp1bwOc_Oim…&formkey=dGlKd2Z2Q1lNSGQ0THl1azM5MS1aWWc6MA&rm=full#gid=0 subitem not at all important 1 2 3 4 5 essential 17a) For each primary and secondary outcome, results for each group, and the estimated effect size and its precision (such as 95% confidence interval)

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).
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 briefly explain why the item is not applicable/relevant for your study 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 briefly explain why the item is not applicable/relevant for your study "Results for our primary outcome variable MDMQ indicate that post-intervention positive affectivity improved [b=0.27; 95% confidence interval (CI) 0.062-0.483] and that patients became calmer (b=0.98; 95%CI 0.740-1.211) following smartphone-based interventions (see Table 2). However, participants did not experience significant changes in wakefulness pre-, compared to post-smartphone-based intervention (b=0.17; 95%CI -0.081-0.412). This was irrespective of the type of smartphone-based intervention. As depicted in Table 3, we did not find any interaction effect between the type of smartphone-based intervention and the change from pre-to post-assessment for positive affectivity ( Table 4). Again, these effects were independent of the type of smartphone-based intervention. As indicated in Table 5, there were no significant interaction effects between the type of smartphone-based intervention and the comparison of pre-and post-assessment for the experience of presence (b=0.14; 95%CI -0.104-0.384), the experience of vitality (b=0.06; 95% CI -0.152-0.265), and the experience of burden (b=-0.16; 95%CI -0.358-0.017). Furthermore, by calculating separate models for the two intervention types (see Table 6), we found evidence that there was a significant increase in wakefulness in the bodily intervention (b=0.25; 95%CI 0.050-0.442), but not in the fairy tales intervention (b=0.09; 95%CI -0.109-0.290). In contrast, we found no significant pre-to post-changes of experience of presence, vitality, and burden when calculating separate models for the two intervention types (see Table 7). The results of the effects related to the face-to-face BPT intervention will be reported elsewhere (personal communication by Grossert and colleagues, 2022)." 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 definitions 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 defined (e.g., timeout after idle time) [1] (report under item 6a).

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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 briefly explain why the item is not applicable/relevant for your study "These patients participated in 65.5% of the smartphone-based bodily interventions (n=354/540) and in 70% of the smartphone-based control interventions (n=378/540). The frequency distribution of interventions per category over all patients is depicted in Online Supplement Figure 1." 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 briefly explain why the item is not applicable/relevant for your study 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 briefly explain why the item is not applicable/relevant for your study Not applicable: no subgroup or adjusted analyses.

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 18-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 briefly explain why the item is not applicable/relevant for your study

19-i) Include privacy breaches, technical problems
Include privacy breaches, technical problems. This does not only include physical "harm" to participants, but also incidents such as perceived or real privacy breaches [1], technical problems, and other unexpected/unintended incidents. "Unintended effects" also includes unintended positive effects [2].

Does your paper address subitem 19-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 briefly explain why the item is not applicable/relevant for your study Restate study questions and summarize the answers suggested by the data, starting with primary outcomes and process outcomes (use).

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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 briefly explain why the item is not applicable/relevant for your study "Our study aimed at evaluating the potential of smartphone-based interventions, focusing on related mood changes from pre-to post-intervention in cancer survivors with body image disturbances. We applied two types of smartphone-based interventions, using a withinsubject design. Over the course of five consecutive weeks, participants were randomly assigned daily to either the bodily or fairy tale intervention. We blended face-to-face psychotherapy with this smartphone-based intervention. Results indicate that posttreatment cancer patients' mood improved following smartphone-based interventions, irrespective of the type of intervention." 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 briefly explain why the item is not applicable/relevant for your study "Finally, it is yet to be determined for how long the observed mood improvements following smartphone-based intervention persist in cancer survivors."

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.

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05.04.22, 14:54 CONSORT-EHEALTH (V 1.6.1) -Submission/Publication Form Seite 56 von 62 https://docs.google.com/forms/d/e/1FAIpQLSfZBSUp1bwOc_Oim…&formkey=dGlKd2Z2Q1lNSGQ0THl1azM5MS1aWWc6MA&rm=full#gid=0 21) Generalisability (external validity, applicability) of the trial findings NPT: External validity of the trial findings according to the intervention, comparators, patients, and care providers or centers involved in the trial 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 briefly explain why the item is not applicable/relevant for your study "Limitations of this study include a rather small number of included patients, which was only partially compensated by the up to 30 smartphone-based intervention sessions per patient. Our study was also limited by the fact that women with breast cancer were overrepresented. Although our group BPT was open to all post-treatment cancer patients with any malignant neoplasm, only four men participated. This should be taken into consideration, when generalizing our findings. Furthermore, we could not blind participants with regard to the intervention. Hence, it is possible that patients were aware of what was the intervention of interest (bodily intervention) and what was the comparator (fairy tales). This may have resulted in biased mood assessments pre-and post-smartphone-based interventions. Nevertheless, we did not inform patients that the overall goal of the smartphone-based interventions was to compare the effects of bodily interventions with that of fairy tales on mood. Importantly, we measured changes in mood but not in bodily disturbances in relation to the smartphone-based interventions. Changes in bodily wellbeing were merely assessed at baseline (T0) and pre-(T1) and post-(T2) group face-to-face BPT intervention [15]. Thus, it remains unclear whether there were differences in effectiveness between the two smartphone-based interventions in terms of changing bodily disturbances or body mindfulness. It was not possible to verify whether patients actually performed the smartphone-based bodily interventions or whether they just listened to the audio instructions. Thus, we could not distinguish between potential effects on mood which resulted from merely listening to audio guided bodily interventions and potential effects from performing the exercises."

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

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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 briefly explain why the item is not applicable/relevant for your study "Our study was also limited by the fact that women with breast cancer were overrepresented. Although our group BPT was open to all post-treatment cancer patients with any malignant neoplasm, only four men participated. This should be taken into consideration, when generalizing our findings."

21-ii) Discuss if there were elements in the RCT that would be different in a routine application setting
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. 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 briefly explain why the item is not applicable/relevant for your study

Meine Antwort
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 briefly explain why the item is not applicable/relevant for your study "Trial Registration: ClinicalTrials.gov NCT03707548" 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 briefly explain why the item is not applicable/relevant for your study "Grossert A, Meffert C, Hess V, Rochlitz C, Pless M, Hunziker S, Wössmer B, Geuter U, Meinlschmidt G, Schaefert R. A clinical trial of group-based body psychotherapy to improve bodily disturbances in post-treatment cancer patients in combination with randomized controlled smartphone-triggered bodily interventions ( 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 briefly explain why the item is not applicable/relevant for your study "This study was funded by the Swiss Cancer League (Grant-No: KLS-4304-08-2017). The funding source was not involved in the design or conduct of the study, in the collection, management, analysis or interpretation of the data, or the preparation, review or approval of the manuscript.

X27-i) State the relation of the study team towards the system being evaluated
In addition to the usual declaration of interests (financial 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.
Does your paper address subitem X27-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 briefly explain why the item is not applicable/relevant for your study

Meine Antwort
As a result of using this checklist, did you make changes in your manuscript? * What were the most important changes you made as a result of using this checklist?