Digital Cognitive Behavioral- and Mindfulness-Based Stress-Management Interventions for Survivors of Breast Cancer: Development Study

Background Psychosocial stress-management interventions can reduce stress and distress and improve the quality of life for survivors of cancer. As these in-person interventions are not always offered or accessible, evidence-informed digital stress-management interventions may have the potential to improve outreach of psychosocial support for survivors of cancer. Few such digital interventions exist so far, few if any have been developed specifically for survivors of breast cancer, and few if any have attempted to explore more than 1 distinct type of intervention framework. Objective This study aimed to develop 2 digital psychosocial stress-management interventions for survivors of breast cancer; 1 cognitive behavioral therapy-based intervention (CBI), and 1 mindfulness-based intervention (MBI). Methods The development of the CBI and MBI interventions originated from the existing StressProffen program, a digital stress-management intervention program for survivors of cancer, based on a primarily cognitive behavioral therapeutic concept. Development processes entailed a multidisciplinary design approach and were iteratively conducted in close collaboration between key stakeholders, including experts within psychosocial oncology, cancer epidemiology, stress-management, and eHealth as well as survivors of breast cancer and health care providers. Core psychosocial oncology stress-management and cancer epidemiology experts first conducted a series of workshops to identify cognitive behavioral and mindfulness specific StressProffen content, overlapping psychoeducational content, and areas where development and incorporation of new material were needed. Following the program content adaptation and development phase, phases related to user testing of new content and technical, privacy, security, and ethical aspects and adjustments ensued. Intervention content for the distinct CBI and MBI interventions was refined in iterative user-centered design processes and adjusted to electronic format through stakeholder-centered iterations. Results For the CBI version, the mindfulness-based content of the original StressProffen was removed, and for the MBI version, cognitive behavioral content was removed. Varying degrees of new content were created for both versions, using a similar layout as for the original StressProffen program. New content and new exercises in particular were tested by survivors of breast cancer and a project-related editorial team, resulting in subsequent user centered adjustments, including ensuring auditory versions and adequate explanations before less intuitive sections. Other improvements included implementing a standard closing sentence to round off every exercise, and allowing participants to choose the length of some of the mindfulness exercises. A legal disclaimer and a description of data collection, user rights and study contact information were included to meet ethical, privacy, and security requirements. Conclusions This study shows how theory specific (ie, CBI and MBI) digital stress-management interventions for survivors of breast cancer can be developed through extensive collaborations between key stakeholders, including scientists, health care providers, and survivors of breast cancer. Offering a variety of evidence-informed stress-management approaches may potentially increase interest for outreach and impact of psychosocial interventions for survivors of cancer. International Registered Report Identifier (IRRID) RR2-10.2196/47195

A recently developed user-centered, feasibility-and efficacy tested digital stress-management intervention for survivors of cancer, StressProffen [22], has been described by survivors of cancer as an appreciated and easily accessible stress-management tool [23].A randomized controlled trial (RCT) showed survivors of cancer (ie, 48% survivors of breast cancer) receiving StressProffen over 12 months, compared to usual care controls, to experience reduced anxiety, depression and self-regulatory fatigue, and improved health related QoL [24,25].StressProffen is considered a cognitive-behavioral stress-management intervention [22][23][24][25], but does, as with other established cognitive behavioral stress-management interventions [26], also include aspects of additional theoretical psychosocial approaches, including mindfulness.
While both CBT and mindfulness have indications of being effective psychosocial interventions for survivors of cancer, reviews examining interventions to improve psychological well-being and QoL in patients with cancer have pointed to CBT as the gold standard intervention with evidence of effect, and the evidence of MBIs being more mixed [27], with existing mindfulness-based studies potentially experiencing methodological limitations [27,28].For example, a systematic review of systematic reviews examining a number of rehabilitation interventions following breast cancer, found convincing material (ie, several meta-analyses and systematic reviews) of CBT interventions having positive impact on anxiety, depression, QoL, mood disturbance, body image, sleep disturbances, and self-esteem.However, only 1 meta-analysis indicated that mindfulness-based stress reduction could also improve anxiety, depression, stress, and overall QoL [29].Other reviews, for example, examining impact of CBT and mindfulness on sleep disturbances in survivors of cancer, have found both CBT and mindfulness for insomnia to be effective [30], although with CBT often being pointed to as having the strongest effect and the findings for MBIs being somewhat more inconsistent [28].There are however studies pointing to MBIs as effective in coping with chronic health disorders including cancer [11,12,31], and a recent systematic review found mindfulness-based stress reduction interventions to be less costly and more effective when compared with the usual care of CBT among patients with health challenges including breast cancer [32].
To date, digital self-management interventions examining and comparing asynchronous cognitive behavioral and mindfulness intervention approaches for survivors of cancer are at best scarce, even though the preference and suitability of these interventions may vary for the potential end users.

Objectives
This study aimed to develop 2 distinct asynchronous digital psychosocial stress-management intervention programs for survivors of breast cancer, based on the existing StressProffen intervention; one cognitive behavioral therapy-based intervention (CBI) and one MBI.

Study Design
The development process contained a multidisciplinary design approach with elements from user-centered design.

The Original StressProffen Intervention Program
StressProffen is a digital evidence-based stress-management intervention program for survivors of cancer, delivered as an app, developed by the Department of Digital Health Research at Oslo University Hospital.The original StressProffen program was designed, developed, and tested (ie, feasibility and efficacy) in close collaboration between researchers, eHealth experts, privacy and security experts, psychosocial-oncology health care providers, and survivors of cancer [22][23][24][25].The program contains 10 primarily cognitive-behavioral stress-management based modules, with aspects from mindfulness.For details on design, development, and usability testing, please see Børøsund et al [22] 10) review and summary.Each module consist of separate steps (ie, 9 to 14 steps), and contains a combination of psychoeducational material, suggestions, words of wisdom and exercises (eg, diaphragmatic breathing, mindfulness, progressive muscle relaxation, and thought challenges).Users of the program can at any point choose between reading or listening (ie, written content spoken verbatim).To encourage reflection and practice there is a 3-day delay after the user has completed 1 module before being able to access the next module.To provide structure and allow for individualization, the 4 first modules are sequential, while the order of modules 5-9 can be individually chosen.Module 10 provides a review and suggestions for "the road ahead."

Overview
Aiming to use the existing StressProffen as a basis to develop 2 interventions, the goal was for the content of the interventions to be the main differing characteristic, developing and delivering the CBI and MBI versions in an identical format with relatively similar complexity.The core content development group (LSN, AM, HRE, and GU) met in biweekly to monthly workshops to examine and decide on specific content to include or exclude in the development of the new StressProffen versions.An expanded content development team (GU, LSN, AM, HRE, EB, and CMR) then continued to meet in biweekly to monthly workshops during the next phase to discuss content and adjustments needed for the new CBI-and MBI-versions.In addition, the larger project group, consisting of the expanded project content group, breast cancer experts, national and international psychosocial oncology-, CBT-and mindfulness-experts, a user representative (ie, representing women with breast cancer) and eHealth experts met twice and discussed aspects of the new interventions.The development process consisted of the steps described below.

Program Content-Adaptation and Development
To ease the comparison of the content of each section, the StressProffen original content was first transferred to a Word (Microsoft Corp) document with the pages split in 2 separate columns.Identical text was included for each section in each column to allow for easy comparison of content.Further, 4 experts within stress-management, CBT, mindfulness, and cancer epidemiology (LSN, AM, HRE, and GU), the core content development group, first independently reviewed the text and placed the content in the CBI or MBI columns based on their personal evaluation of the content.All members of the group used the "track changes" function in Microsoft Word, and then met to discuss steps for further project progress.General psychoeducational content was discussed and primarily kept in both versions (ie, CBI and MBI).For the distinct CBI-version, mindfulness-based content was identified and discussed for potential deletion or adjustment.For the MBI-version, CBT-based content was identified and discussed for potential deletion or adjustment.Need for additional modifications or new material for either of the 2 distinct versions was also identified and a detailed plan for further development formed.
To ensure harmonized interventions related to module length, number of intervention or module steps and number of exercises, new material was developed (eg, when deleting mindfulness-based content from CBI or vice versa) by the 4 core experts (LSN, AM, HRE, and GU).The adjustment of existing and development of new CBI-based content was led by LSN and HRE, while the adjustment of existing and development of new mindfulness-based content was led by AM.To ensure easily understandable language and fit with the original StressProffen program, any new content was reviewed by members of the content editorial team at the Department of Digital Health Research, and uncertainties discussed within the expanded content development team (LSN, AM, HRE, GU, EB, and CMR) and with user representatives when deemed necessary.To calculate proportion of content retained, adjusted, or removed, module steps in the new versions were compared with module steps in the original StressProffen program.

User Testing of New Exercises
As the original StressProffen content has already been user tested by survivors of cancer as well as health care providers [22], only new, developed content was user tested in the 2 new versions.To ensure user-friendliness of particularly new exercises, women with breast cancer were invited to test any new exercises developed for the 2 distinct versions.The project user representative invited women in breast cancer groups (eg, local organizations) to participate in user testing, and women interested in participating were given oral and written information and provided written informed consent prior to participation.In addition, a project-related editorial team at the

Technical and Static Aspects and Adjustments
The original StressProffen program also contains static pages with reminders, "quotes of the day," and privacy and security information.To ensure that these static pages were in line with what is to be expected in the more "pure" CBI and MBI interventions, the core content development group (LSN, AM, HRE, and GU) reviewed the static text independently, applied the "track changes" function in Microsoft Word, met to discuss findings, and then reached decisions regarding removal, modification, or addition of content for the 2 versions.

Ethics Approval
The most recent version of the StressProffen technical platform, already approved by the hospital privacy and security protection committee, was used for the development of the StressProffen CBI-and MBI-versions, and the 2 new program versions were subsequently approved through the existing organizational StressProffen risk assessment.All user testing procedures were approved by the hospital privacy and security protection committee (18/13312).The participating women with breast cancer provided written informed consent prior to user testing, and received a gift card equivalent of US $30 as compensation for their time and for travel expenses involved.Data from user testing (written notes) were stored deidentified at a secure server at the hospital.

Program Content-Adaptation and Development
General psychoeducational content was discussed and primarily kept in both versions (ie, CBI and MBI), with the MBI-version incorporating additional material for more mindfulness-based psychoeducational content.Of total content (ie, psychoeducational material, exercises, suggestions, and words of wisdom), 69% (76/110 steps) of the original StressProffen content were retained in the StressProffen CBI-version and 23% (28/123 steps) in the StressProffen MBI-version.Minor therapeutic language adjustments were conducted to adhere to the distinct style commonly used by CBT and mindfulness practitioners, respectively 25% (27/110 steps) for the CBI-version and 44% (54/123 steps) for the MBI-version.In addition, 6% (7/110 steps) of the original content was removed for the new CBI-version and 33% (41/123 steps) removed for the MBI-version.Adhering to the structure of the original StressProffen intervention, development of new mindfulness-based content was led by AM in collaboration with the core content development group.In this context, some content and exercises from Carlson and Speca's MBIs [33] for coping with cancer was translated into Norwegian, adapted to the app format, and incorporated with permission from Carlson.Please see Figures 1 and 2 for an overview of program content adaptation and development.
To enable future program comparisons, both program versions were developed using the exact same StressProffen set-up and layout.The 2 final interventions therefore had the same basic structure and contained 10 modules with 9 to 16 steps each.While the MBI-version contained slightly more words (ie, total 33,020 vs total 30,134 for CBI) and lasted longer (approximately 6 hours compared to approximately 5 hours for CBI), the CBI-version contained more exercises (38 vs 30).These slight variances were deemed necessary for proper content presentation of each version and adhering to the basic tenants of CBT and mindfulness.MBIs typically revolve around fewer exercises than CBT, as excess variation could inhibit the development of mindfulness [31].The reason for including some more text in the MBI was related to the need to explain some of the mindfulness exercises.For example, user tests (see next section) indicated that mindfulness exercises involving sitting in silence needed more explanations than CBI exercises.
The team otherwise strived to balance the number and length of modules and subsections, exercises, and figures as much as possible, and both versions allowed for setting reminders, marking favorite exercises and educational content, and for choosing between reading or listening.Please see Table 1 for a detailed overview of modules and steps in the 2 program versions.c In 1 exercise, the participants could choose between spending 10 or 20 minutes on the exercise.This summary is based on a 10 minute exercise.

User Testing of New Exercises
The newly developed exercises were audio-recorded prior to testing.User representatives (ie, 4 women with breast cancer) and 3 members of a project-related editorial team tested the new exercises in iterations.The user representatives stated that the opportunity to listen to the exercises, not only having to read, would be considered important, and that the type of voice (eg, calm and engaging) would be crucial for maintaining their interest for further program use.As the new mindfulness-based exercises also had silence (ie, quiet time) incorporated into the exercises, some of the users expressed experiencing some frustration with the silence, describing "loosing the flow" in the exercise when not hearing anything.Even a 5 second break was experienced as a long time for the users, and they stated that the silence could make thoughts occur related to their illness or situation.Silence is regarded an essential ingredient to receive the long term benefits of mindfulness, and could not be completely removed from the MBI version.However, this feedback from participants resulted in a more extended explanation before the exercises involving silence, and a shortening of some of the silent sections in the new mindfulness exercises.The users did describe silence in exercises focusing on bodily sensations (eg, "Silent body scan" and "Body scan") as easier to accept, and the silence parts of these exercises were kept.The participating end users also stated that some of the new mindfulness-based exercises appeared to have abrupt endings.This feedback resulted in both versions (ie, CBI and MBI) incorporating the original StressProffen "closing sentence" (eg, "The exercise is now completed, and you are ready to move on to the next part") at the end of all exercises.

Technical and Static Aspects and Adjustments
The original StressProffen has an option for reading a "quote of the day" (ie, 55 different quotes) through using a specific button when opening the app.In the CBI-version, all quotes of the day were kept and 1 additional quote (ie, "We can easily manage if we will only take, each day, the burden appointed to it.But the load will be too heavy for us if we carry yesterday's burden over again today, and then add the burden of the morrow before we are required to bear it"-John Newton) included.This quote was also added to the MBI-version.In the MBI-version, 11 original StressProffen quotes were removed, for example, to limit indications of self-judgement (eg, "Don't underestimate yourself by comparing yourself to others.It's our differences that make us unique" [Unknown]).
The original StressProffen also has 33 quotes or words of wisdom used as "additional reminders."Of these, 8 were removed from the CBI-version due to mindfulness-related content, (eg, "To be mindful is to be grateful," "To be mindful is to focus on the here and now"), and 5 were added (eg, "Don't let the past or the future guide you, concentrate on the here and now"; "Allow yourself to smile or laugh, even when things are difficult"; "Think about it, what are you grateful for?").In the MBI-version, 13 of the "additional reminders" were removed (eg, "Think of something that you can do before the day is over that gives meaning," "To live your life the way you want to can make you stronger in body, mind and soul") and 5 added (eg, "Can you observe your thoughts without evaluating them?"; "Take time to relax, or do something you like"; "Do things you like doing").

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A functionality to allow participants to choose the length of a mindfulness exercise (ie, 10 or 20 minutes) was also included in the MBI-version.Finally, to ensure the new app versions met with all ethical, privacy, and security requirements (eg, General Data Protection Regulation and Apple or Google requirements), a legal disclaimer and privacy protection details was developed and included aspects such as description of data collection, storage, user rights, and study contact information in case of questions or technical issues.See Figure 3 for screenshots from the CBI-and MBI-versions.

Principal Findings
This study shows how theory specific digital stress-management interventions for survivors of breast cancer can be developed combining existing evidence and key stakeholder (eg, scientists, health care providers, and end user) input, centering around content adaptation and development, user testing and adjustment of technical, static, and privacy and security aspects.Findings show how the original StressProffen content was examined, overlapping content (ie, non-CBT or mindfulness specific) identified and retained.Mindfulness-based content was removed from the CBI-version, and cognitive behavioral content removed from the MBI-version, with varying degrees of new or adjusted content created for both versions, resulting in 2 distinct CBI and MBI interventions.

Providing Options for Personal Stress-Management Preferences
CBT as well as MBIs may provide effective psychosocial support for survivors of cancer [11,12,27,29].Studies comparing these types of digital self-management interventions are at best scarce, and this study provides a basis for conducting such comparisons.Presentation of content, controlling for format, display, content, and length, may as such allow for a true comparison of theoretical approaches (ie, CBT vs mindfulness).
Whether being able to choose between types of self-management interventions can in fact impact outcome remains to be seen, but people's preference for treatment type, for example, type of psychotherapy vary [34,35], and user input does suggest that personal choice can increase motivation to engage in self-management, strengthening adherence, and potentially also impacting outcome.Studies matching patients' treatment preferences with the intervention received, do not consistently impact treatment outcome however [36].For example, a study examining the outcome of CBT versus MBIs in an RCT with participants diagnosed with social anxiety disorder did not find being assigned to personally preferred treatment, or not, to significantly impact treatment outcome [37].Other studies have found the opposite to be the case.For example, 1 study comparing treatment program preferences in distressed survivors of breast cancer found a mindfulness-based cancer recovery intervention to be preferred over supportive expressive therapy or a 1-day stress-management seminar, and in an RCT found matching preference to treatment option, regardless of intervention received, to be effective when related to QoL and spiritual well-being [38].Distinguishing between having a choice and actually making a choice may also be of interest, as 1 study found having a choice to be associated with more positive patient outcomes in terms of mood, patient satisfaction, perceived control, and less desire to seek further information than if having only 1 choice [39].In the same study, actually making a choice appeared to have no impact on patient outcomes [39].
While CBT is often considered the "gold standard" for psychosocial stress-management interventions in cancer [27], a growing body of evidence supports the use of mindfulness for patients with cancer as well [11,12].Which types of interventions work the best for which types of people, demographic variables, or cancer groups, however, remains to be seen.For people already having knowledge of, or known preference for, 1 theoretical approach (eg, preference for mindfulness or preference for CBT), actually being able to engage in this type of intervention could be of benefit for motivation, engagement, and intervention adherence, and subsequently also for future impact and outcome.

Potential Impact for Future Research
The adaptation and development processes in this study strived to design the interventions in a way that the only differing factor would be whether a patient would be exposed to the active ingredients of CBT or mindfulness.Findings show how this goal was primarily achieved, despite the final MBI-version being slightly longer, with more steps and total words and auditory length compared to the final CBI-version, and the CBI-version having more exercises compared to the MBI-version.These variations are however minor, and could be justified in the differences of methodology (eg, necessity for more explanatory, guided exercises in CBT, and necessity for more elaborate wording related to "being present and nonjudgmental"-and the need for incorporating sections of silence in exercises-in mindfulness).Consequently, any future differential effects across the 2 interventions during comparison studies would likely be due to the mechanisms driving the effects of cognitive behavioral-and mindfulness-based methodology in survivors of cancer, rather than confounding factors such as design, layout, textual, or auditory length or other nontheoretical factors.Future research might also aim to incorporate other clinical therapeutic approaches in cancer, such as, for example, acceptance and commitment therapy [40], for exploration in digital interventions.Analysis of usage patterns could also add to knowledge about how the different programs are implemented and used over time.As various formats and visual presentations created across study teams could impact interest in, and actual use of, interventions, comparing result across studies and research teams might prove difficult, however.Future studies embarking on a similar challenge should nevertheless keep striving to make the interventions as similar as possible while retaining the differences in mechanisms.
The original StressProffen intervention is primarily CBT-based, but also contains options for reminders in the form of inspirational quotes, as well as the choice of sequence between modules 5 to 9, the possibility to register daily stress levels, and the option to mark favorite exercises in a "my page" section [22].These options were retained in both new versions, offering additional choices in support of personal preferences.Stakeholder input in this study, including from survivors of breast cancer and oncology health care providers, supported previous research underlining the importance of being able to choose between reading or listening [22,23].Findings also pointed to a need for clear explanations for sections that might not be self-explanatory, such as, for example, areas of silence in the mindfulness-based version, underlining the need for interventions to be tailored to the patients' needs [41].
Posttesting the asynchronous CBI and MBI versions in a clinical trial, future research could also consider building therapist-guided aspects into the interventions.As such, including synchronous components to asynchronous platforms could potentially enhance the effect and make the intervention more known to patients.Given the importance of health economic aspects in health care and health care research, health economy should also be evaluated to inform future implementation into regular practice.

Limitations
This study has a number of limitations.First, user testing was performed by only 4 survivors of breast cancer.However, the original StressProffen intervention was developed with user input, enabling user testing of primarily new exercises in the 2 new versions.In addition, project team members, including health care providers, also conducted extensive testing of the new CBI and MBI versions.
Second, although striving to keep the 2 interventions equal in structure and length, the MBI version ended up including somewhat more extensive content, with more steps and words, and the audio files subsequently lasting longer than those in the CBI version.Some of this can be explained by the nature of MBI, with more silence in the audio-files needing explanations, but a potential impact of this difference in length should be examined in future studies comparing the 2 distinct intervention versions.
Third, some of the adaption and development of program content were conducted during the COVID-19 pandemic, meaning that several workshops had to be conducted digitally due to pandemic restrictions.This could potentially have impacted the development process.However, the core and expanded content development groups had met in person several times prior to the pandemic, making the productivity and ease of digital meetings acceptable.Collaborating on text evaluation and progress was also easily conducted first through email and subsequently through digital discussions.

Future Directions
This study sought to describe a method for developing distinct digital psychosocial stress-management interventions based on an existing evidence-based, user-centered intervention.Future studies should examine whether distinct interventions based on CBT and mindfulness can have positive impact for survivors of breast cancer, and an RCT exploring such impact (ie, through

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RenderX the research project Coping After Breast Cancer, Principal Investigator Giske Ursin of the Norwegian Cancer Registry) is currently underway [42].In the future, if found to be of equivalent usefulness, potential, and impact, patients with cancer could opt to choose between CBT and mindfulness-based digital psychosocial stress-management programs, based on preferences.Potential impact of receiving the preferred intervention or not should however also be explored.

Conclusions
This study shows how theory specific digital stress-management interventions for survivors of breast cancer can be developed through extensive collaborations between key stakeholders with the right expertise.In this case, including scientists, health care providers, and survivors of breast cancer.Offering a variety of digital evidence-informed stress-management approaches may increase interest for, as well as outreach of, and potentially also impact of, psychosocial interventions for survivors of cancer.

Table 1 .
Overview of modules and steps in the CBI a and MBI b programs.