The 5-year survival rates for female survivors of breast cancer have increased from 63% in the 1960s to 90% currently, with >3.6 million survivors of breast cancer in the United States today [1]. There is a large body of evidence on the benefits of aerobic exercise to alleviate sequelae of cancer treatments when conducted with onsite supervision, as well as home-based programs [2-6]. Hence, the American College of Sports Medicine [7] and the American Cancer Society (ACS) [8] recommend that survivors participate in aerobic exercise at moderate to vigorous intensity for at least 150 minutes per week. However, only 24% to 44% of survivors meet these guidelines [8].

The literature suggests that leveraging peer support may help improve moderate to vigorous physical activity (MVPA) adoption among survivors of breast cancer [9]. Sociocultural and communication theories suggest that people are more receptive to assistance when it is delivered by someone perceived as similar to oneself (eg, of comparable age and life experiences) [10]. Peer support for health is used to maximize impact, sustainability, and scale-up of successful interventions while facing limited resources and contextual constraints. With the growing evidence of the key role that physical activity (PA) can play in cancer recovery, we are one of the first teams to extend these research findings into the “real world” by training community volunteers to encourage survivors to adopt MVPA [11-13].

We chose to test the dissemination potential at the ACS, a not-for-profit community-based organization. Specifically, ACS’ Reach to Recovery peer mentors provide emotional support and information to patients with cancer. Hence, it was a “natural fit” to test the effects of these peer coaches encouraging sedentary survivors to become more physically active to enhance their recovery from cancer treatment. Our prior randomized controlled trial (RCT) showed that this peer-delivered intervention (Moving Forward Together [MFT]) was effective in increasing survivors’ MVPA [12]. Coaches who were trained and supervised to provide MVPA counseling via telephone calls to other survivors of breast cancer effectively helped them significantly increase their MVPA to a mean of 129 minutes per week at 12 weeks (P<.05).

The telephone counseling component of our evidence-based MVPA intervention is based on the Transtheoretical Model (TTM) [14,15] and Social Cognitive Theory (SCT) [16] of behavior change that have been applied to exercise behavior. Key constructs from the TTM (motivational readiness) and SCT (self-efficacy and beliefs about the importance of MVPA in reducing fatigue etc) underlie the telephone counseling that coaches delivered to survivors in our prior work [12]. We plan to extend these individual-level theories with frameworks from the field of dissemination and implementation science to assess contextual and organizational-level factors that are critical to planning for large-scale implementation of our evidence-based intervention. We will use the expanded Reach, Effectiveness, Adoption, Implementation, Maintenance (RE-AIM) framework of implementation outcome dimensions that includes a model of key contextual determinants of successful implementation, that is, the Practical, Robust Implementation and Sustainability Model (PRISM) [17,18]. RE-AIM has been in use since 1999 and has been applied widely to plan and evaluate the translation of many interventions in primary care and community settings, including smoking cessation interventions, diabetes management, and MVPA promotion [19,20]). As PRISM operationalizes the organizational staff and survivor domains that influence implementation success, we will use PRISM to identify contextual and organizational factors that influence RE-AIM outcomes [18].

To address the gap in the literature of limited real-world translation of MVPA promotion among survivors of cancer, our study objective is to develop and test the implementation of Mentor1to1 web platform adapted for MFT (webMFT) as a scalable intervention to effectively increase MVPA among survivors of breast cancer. The study has 2 phases: phase 1, which includes aims 1 and 2, and phase 2 which includes aim 3.

The study will consist of 2 phases: phase 1 will involve the adaptation and user-centered testing of Mentor1to1 for MFT. We will recruit coaches from past studies who have previously delivered the MFT program. These coaches have experience with intervention content and delivery and thus will be able to provide informed feedback. In phase 2, we will test webMFT using a randomized controlled design.

Phase 2 will be an RCT of webMFT wherein 10 to 12 coaches (naive to the MFT program, across the collaborating cancer care organizations that have peer mentoring programs) will be trained to deliver webMFT to survivors of breast cancer. We will recruit 56 survivors of breast cancer and randomize them to webMFT (assigned a coach to deliver intervention via the web platform) or an MVPA tracking group (independent MVPA tracking; refer to Figure 1). We will use multiple methods to examine the acceptability and feasibility of the coaches using webMFT and to gather data on the implementation and effects of webMFT on survivors’ MVPA (primary outcome), mood, QOL, physical functioning, and fatigue at baseline and 12 weeks. Finally, we will conduct individual interviews with multilevel stakeholders at the collaborating organizations to collect data, based on RE-AIM outcome dimensions and PRISM domains, to guide the implementation of webMFT on a larger scale.

Mentor1to1 is a web-based platform for coach and survivor enrollment; survivor-to-coach matching; one-on-one remote coach mentoring via phone, text, and smartphone messaging; automated MVPA tracking via Fitbit; and administrator oversight and support. Access to the system by both the coach and staff is password protected. Within the webMFT, the coach will be able to review information from prior calls (eg, a survivor’s MVPA recorded by a Fitbit activity tracker) and review information for the upcoming call (eg, counseling questions). When ready for a call to a webMFT participant, the coach will click a button on the computer to initiate the call. The system calls the survivor and connects the coach and survivor for a one-on-one telephone conversation. This avoids the need to exchange contact information. All calls are generated from a secure server, allowing the tracking of call frequency, length, and recording for quality control, safety, and training purposes, while respecting Health Insurance Portability and Accountability Act (HIPAA)–mandated security and privacy requirements. During the call, coaches will be expected to document their discussion for each specified counseling question; additional notes can be taken throughout the call within the platform. At the end of each call, coaches will collaboratively set MVPA goals with the participants, discuss strategies to achieve those goals in the upcoming week, and schedule the next call. As needed, the platform will assist with scheduling time zone differences between the coach and the participant. The system will send email or text reminders to the coach and the participant about their upcoming call.

We will work with cancer care organizations (eg, Cancer Hope Network and Pink Lemonade Project) to recruit coaches and survivors. In total, we will recruit 10 to 12 coaches across the organizations to be trained to deliver webMFT. Each coach will be asked to work with 4 to 5 survivors over the study duration. As in our prior work [12,13], the organizations will mail or email informational letters and brochures to peer mentors, offering them the opportunity to become a coach and receive training in the delivery of webMFT.

Eligibility criteria for coaches include that they must (1) be a current peer mentor (at least 1 year) at the organization; (2) have an email address, telephone access, and access to a tablet or computer with internet to use the web platform; (3) be willing to participate in group training via videoconference; (4) be willing to have calls recorded and reviewed; (5) be willing to be supervised; (6) have a baseline level of digital literacy for this health technology (ie, sufficient internet speed and proficient in typing); and (7) currently exercise for at least 60 minutes per week.

The collaborating cancer care organizations will be asked to send informational mailings or emails about the study to their lists consisting of survivors of breast cancer. Other recruitment avenues will include informational mailings from oncology practices, tumor registries, and community events. Interested survivors will be asked to contact the study’s research assistant who will explain the study and obtain verbal informed consent to conduct a telephone screen for eligibility. If eligible, the staff will send the survivor an informed consent document through REDCap (Research Electronic Data Capture; Vanderbilt University) [25,26]; once signed, participants will be sent a copy for their records. Participants will be mailed a physician consent form for their participation in the study. After the consent forms are obtained, all survivors will be mailed an Actigraph (GT3X; Actigraph LLC) accelerometer to monitor MVPA with instructions and a stamped envelope to return the Actigraph. In addition, they will receive instructions on completing baseline questionnaires within REDCap. After the baseline assessments are completed and the Actigraph has been reviewed for wear time and confirmation of a sedentary lifestyle, participants will be mailed a Fitbit Inspire 2 tracker. Participants will also receive a Fitbit manual and a study username and password to log in to the Fitbit app on their phone. Survivors randomized to the MVPA tracking arm will receive an identical Fitbit in the mail; their data will be tracked directly via the Fitbit Application Programming Interface.

Eligibility criteria for survivors include the following: (1) women aged >21 years; (2) diagnosis in the past 5 years with stage 0 to stage 3 breast cancer (completed surgery, radiation, or chemotherapy, and those currently receiving hormone therapy; physician consent for all study survivors will be obtained); (3) ability to read and speak English; (4) those with sedentary lifestyle (ie, <30 minutes per week of vigorous exercise or <90 minutes per week of moderate intensity exercise for the past 6 months); (5) ability to walk unassisted; and (6) access to a smartphone with Bluetooth and internet access. Women with more advanced disease (stage 4) and medical or psychiatric problems (eg, coronary artery disease, peripheral vascular disease, diabetes, and orthopedic problems) that may interfere with protocol adherence will not be included. These inclusion and exclusion criteria are similar to those used in our prior work [12,13]. Survivors will be asked to provide consent for medical chart review to extract disease and treatment history.

Phase 1 of the study was deemed exempt by the institutional review board of the University of South Carolina (Pro00117242), and phase 2 of the study was approved by the same institutional review board. All study participants and coaches will provide written informed consent to participate in the study.

Study data will be deidentified before analyses and dissemination.

Coaches taking part in phase 1 of the study will be provided with US $100 as an incentive. Coaches taking part in phase 2 will be paid US $30 upon completion of training. In addition, coaches will be provided US $25 on delivering the intervention to their first participant and US $25 during the holiday season. Study participants (survivors) in phase 2 will be paid US $25 for completing baseline assessments and US $25 for assessments at the postintervention time point.

Power calculations were based on data from our prior work with MFT [27], and data from the study by Cadmus-Bertram et al [28], who compared web-based tracking+Fitbit to pedometer alone among postmenopausal women. Comparing the effects of coach counseling [27] to web-based tracking+Fitbit [28] on changes from baseline in MVPA would yield a medium effect size, d=0.60. Assuming similar effect sizes and a 2-sided α=.05, we would have more than sufficient power to test intervention effects on changes in MVPA (minutes per week) at the end of intervention with 20 survivors per arm. However, given the risk of powering on pilot studies, we have conservatively inflated the sample size to 25 survivors per arm. On the basis of our prior work, we expect attrition to be ≤10% at 12 weeks, so we will recruit a total of 56 women (n=28 survivors per arm) to obtain complete data from 50 survivors.

The 2 phases of this work address the adaptation of a web platform for an effective MVPA intervention (webMFT) followed by an RCT to test the effectiveness of webMFT as well as the RE-AIM outcomes of Reach, Adoption, Implementation and Maintenance that will inform future approaches to scale up this intervention. By adapting an existing peer mentoring web-based platform, Mentor1to1 for MFT, an intervention that was proven effective when delivered by phone, we expect to be able to scale up our intervention with fidelity and reduce the costs of intervention delivery. The benefits of this web-based platform include an efficient infrastructure to support coaches to deliver all aspects of the webMFT intervention, including key process steps to accept coaching requests, initiate secure phone calls, send text messages, and view survivor data. Administrative staff will use the web platform to manage the entire program (eg, make coach-survivor matches, review call recordings, and track Fitbit data). By using webMFT, we expect that coaches can reach many more survivors to become physically active, with potential health and psychosocial benefits [7,49,50].

This work is innovative because peer mentoring is relatively new in the PA literature, and to the best of our knowledge, our work in training cancer peer mentors (coaches) to support MVPA adoption in cancer survivors is unique. We plan to use user-centered iterative design for the adaptation and creation of webMFT, while retaining the same established principles and theories used in our previous work with additional technology-based enhancements. The updated web platform will streamline survivor and coach enrollment and will allow staff members to use real-time, multivariate matching between coaches and survivors. The current matching approach is manual, which is time-consuming and expensive. Our web platform–based intervention allows for the delivery of a multichannel (phone, SMS text messaging, and smartphone) peer mentoring approach in what we expect will be scalable, flexible, and low cost. All interactions will be recorded and tracked automatically through the platform, providing full oversight, detailed reports, and tracking of each coach’s time and effort. Finally, we expect that the web platform will integrate with a Fitbit activity tracker to provide automated MVPA data for the coach to review with the survivor during weekly calls. We expect that these features will reduce the need for investment in personnel to coordinate and collect data as well as facilitate intervention delivery.

Adapting our intervention to a web platform will require changes in the training program that we have provided the coaches. Our prior training required 4 in-person or videoconferencing group training sessions, each lasting about 2.5 hours. We will revise our training program extensively to include recorded training modules, a live internet-based group training focusing on training coaches to deliver the counseling content, and an individual training session to familiarize the coach with navigating the web platform while delivering the PA counseling. During the study implementation, we will also track any additional training and time spent by the research team to provide guidance and solve issues related to using the web platform. Careful attention to the changes required and adaptations in our training and supervision will allow the evidence-based intervention to be reliably implemented by cancer care organizations that have peer mentoring programs.

There is a large body of evidence to support the promotion of PA to facilitate the recovery and functioning of survivors of cancers, and numerous PA interventions (onsite, offsite, and hybrid) have been developed. Yet, these interventions have had limited applicability outside of research efforts. Much of the focus in implementing national PA guidelines for survivors of cancers [51-53] has been in health care settings. While there is considerable variation in the needs and challenges faced by survivors of cancers in adopting PA, there is a huge scope for community-based programs to meet the needs of those survivors who can safely become active outside of specialty care (eg, physical therapy and occupational therapy). There are numerous, well-established cancer support organizations in the United States focused on meeting the needs of their communities, especially patients or survivors, family members, and caregivers. Many of these organizations offer peer support programs. Our focus is to leverage the existing resources in these organizations, especially those which recognize the importance of PA in cancer recovery and make MFT more accessible to survivors.

To translate our research and build the capacity to improve survivors’ recovery, we do need to understand multilevel stakeholders’ perspectives on this partnership. By applying user-centered design principles and dissemination and implementation frameworks, we believe that we can design webMFT with dissemination and sustainability in mind from the beginning, thus improving the potential for adoption and sustainment. Key constructs measured with guidance from our expanded RE-AIM framework will inform future implementation efforts and improve our understanding of contextual factors at the levels of survivors, coaches, and organizations, which may influence future the adoption and maintenance of webMFT. Overall, these results will provide rich preliminary data to inform a future, large-scale pragmatic trial to involve multiple cancer care organizations in the delivery of webMFT to survivors of breast cancer across the country.

We have restricted the survivor sample to those who have smartphones. The use of smartphones has increased over time. We are designing for the future when the prevalence of communication technology will be higher; therefore, we anticipate that access will improve.

See Table 4 for the timeline and associated tasks.

The study goals are to gather data to prepare for a larger-scale implementation trial of webMFT in several cancer care organizations that have peer mentoring programs. On a local and regional level, the work will be disseminated at the University of South Carolina–sponsored conferences, journal clubs, and community-based cancer support groups and local hospitals that have oncology programs. In addition, the results will be disseminated via presentations at regional, national, and international scientific meetings. A summary of the study results will be shared with the stakeholders at the organizations that have collaborated on the trial so that they can use the study results to inform their own staff, volunteers, cancer survivors, and potential funders.

Survivors’ MVPA data from the RCT along with quantitative and qualitative data from coaches, survivors, and cancer organizations will provide the foundation for a large-scale implementation trial of the MFT program.