Integrating and adapting three evidence-based interventions to enhance physical activity and reduce psychosocial distress among rural breast cancer survivors: the Mind Your BEAT study

Abstract

Background

Rural cancer survivors are less likely to meet physical activity (PA) recommendations and report higher psychosocial distress than urban cancer survivors due to social, financial, and geographical barriers. Previous PA interventions have been largely unsuccessful because they do not consider unique barriers to PA present in rural communities.

Purpose

Mind Your BEAT (MYB) used a community-engaged approach to adapt an evidence-based intervention for implementation in rural communities and to address psychosocial distress alongside PA. This study describes the information gathering and adaptation process and the study protocol for the feasibility trial of the adapted MYB intervention.

Methods and Results

First, interviews with rural breast cancer survivors and community partners (N = 7) were completed to adapt core components from three evidence-based interventions. Themes from interviews with rural breast cancer survivors and community partners focused on making the program accessible, partnering with trusted community organizations and leaders, and ensuring PA is tailored to physical and emotional needs of cancer survivors. Adaptations were integrated into the MYB intervention. Next, we conducted a feedback session with community scientists to refine intervention protocols prior to implementation of the feasibility trial. Once adaptations were made, we worked with Kourage Health, an existing community- and evidence-based exercise program, to test the feasibility, acceptability, and effects of the intervention. The adapted MYB intervention combined aerobic exercise, group education, and mind-body strategies to increase PA and reduce distress in rural breast cancer survivors. Participants were recruited through Kourage Health and randomized to participate in MYB or usual care. Study evaluation was guided by the RE-AIM framework and the consolidated framework for implementation research (CFIR).

Conclusions

This study underscores the importance of community input in the adaptation of evidence-based interventions to improve reach and implementation in rural community settings and aims to accelerate the translation of evidence-based programs to underserved communities to reduce the research-practice gap.

• A known effective strategy to increase physical activity was systematically adapted for use in rural breast cancer survivors and delivered in rural community settings.

• A community engaged approach to adapting an effective intervention tailored the program to meet the physical and emotional needs of rural cancer survivors.

• Adaptations to the program were made with the goal of improving accessibility and reach among rural breast cancer survivors.

Implications.

• Practice: Community-based physical activity programs that are designed with input from community partners and rural cancer survivors residing in rural areas are needed and can lead to better reach and uptake.

• Policy: Funding and policy makers should encourage the evaluation of implementation of evidence-based programs to move beyond effectiveness and to better understand why programs succeed or fail in diverse settings and populations.

• Research: Findings from this study contribute to our understanding of how to adapt and implement evidence-based interventions effectively to improve psychosocial wellbeing and physical activity among cancer survivors residing in rural areas.

Background

There are more than 18 million cancer survivors in the United States, and the number of people living with and beyond cancer continues to grow due to advances in early detection and cancer treatment [1]. As the number of cancer survivors increases and the population ages, there is a greater risk of cancer recurrence and developing comorbidities [2–4]. Physical activity (PA) reduces the risk of cancer recurrence and comorbidities [5] and improves aerobic fitness, strength, flexibility, quality of life, and psychosocial well-being after cancer diagnosis [6, 7]. Yet, less than 20% of cancer survivors are sufficiently active [8–10]. High levels of psychosocial distress, including fear of recurrence, anxiety and depression, are common in cancer survivors and contribute to physical inactivity [11–13]. Position statements and guidelines from the Institute of Medicine and National Comprehensive Cancer Network (NCCN) have urged for monitoring and addressing the unmet psychosocial needs of cancer survivors. In particular, the NCCN guidelines highlight the need for interventions to reduce distress and improve quality of life in cancer survivors who may not meet the criteria for full clinical psychiatric diagnosis of anxiety, depression, posttraumatic stress disorder, and other forms of psychosocial distress [12].

In light of guidelines, some progress has been made to increase PA and decrease psychosocial distress in cancer survivors over the past several decades [14, 15]. In particular, yoga has been shown to reduce negative psychosocial side effects of cancer and its treatment in urban cancer survivors [16]. However, there is limited research on interventions that integrate PA promotion with mind-body strategies to reduce psychosocial distress in cancer survivors, including those living in rural areas [17, 18]. Rural cancer survivors have a higher prevalence of psychosocial distress and physical inactivity compared to urban cancer survivors due to geographical barriers, financial burden, social isolation, and lack of physical and psychosocial support and services [8, 18–22]. Previous interventions to promote PA among rural cancer survivors were translated from urban settings and populations have been largely unsuccessful because they do not consider the barriers to PA present in rural communities [17, 23]. Therefore, there is a need for PA programs that address the barriers unique to rural cancer survivors and rural settings, while addressing both PA promotion and reducing psychosocial distress.

In an effort to develop a community-based PA program for breast cancer survivors living in rural areas who are not meeting PA recommendations and report greater psychosocial distress, we adapted an evidence-based PA intervention. This study was conducted in two phases: information gathering and adaptation of an evidence-based intervention (Phase 1) and feasibility testing and evaluation of the adapted intervention (Phase 2). In Phase 1, we used a staged, community-engaged approach guided by the adaptome framework [24] to adapt an evidence-based intervention for rural breast cancer survivors and for implementation in a rural community setting [24, 25]. In Phase 2, we conducted a randomized controlled feasibility trial to evaluate community-based implementation of the adapted intervention guided by the Consolidated Framework for Implementation Research (CFIR) and RE-AIM framework [26, 27]. This study describes information gathering and the adaptation process used in Phase 1 and the study protocol for the feasibility trial conducted in Phase 2. Importantly, this study addresses a critical gap in knowledge related to the translation of evidence-based interventions into sustained practice within rural community settings and, if successful, could aid efforts to improve rural cancer prevention and control and reduce cancer disparities in rural communities.

Phase 1: Information Gathering and Adaptations

Methods

To adapt BEAT cancer for rural breast cancer survivors and for implementation in a rural community, we first conducted one-on-one in-depth interviews with five community partners and clinicians and two rural breast cancer survivors. Inclusion criteria for community partners included: (i) Works with breast cancer survivors (e.g. oncologists, primary care physicians, oncology nurses, community health workers, nonprofit agency employees, cooperative extension agents and volunteers, pastors/reverends, community church leaders, etc.); (ii) place of engagement falls within a rural county in Texas; (iii) able to read, speak, and write in English; and (iv) at least 18 years old. Inclusion criteria for rural breast cancer survivors included: (i) Women ages 18–70; (ii) history of ductal carcinoma in situ or Stage I–IIIA breast cancer; (iii) ≥12 weeks but <5 years postsurgery and treatment; (iv) able to read, speak, and write in English; and (v) have access to a smartphone, tablet, or computer and willing to participate in interviews virtually. Semistructured interview guides were developed to identify community needs, PA program preferences, and barriers to address and overcome in the adapted intervention. Interviews took place August–November 2021 and were conducted via Zoom videoconference or in-person, digitally recorded, and transcribed. Rapid qualitative analysis methods were used to analyze transcripts and identify common themes, which were used to make initial adaptations to the study. Findings from interviews supplemented those from a previously reported study of multilevel barriers and PA program preferences among rural breast cancer survivors [28, 29] resulting in early saturation [30].

Next, we conducted a feedback session with the Community Scientist Program (CSP) in the Center for Community-Engaged Translational Research at The University of Texas MD Anderson Cancer Center. The CSP offers support to researchers on specific aspects of their study by connecting them with community members who have been trained to provide feedback on research. Additional adaptations were made to address feedback from community scientists and refine intervention protocols before implementation of the feasibility trial.

Results

Common themes identified in interviews with rural cancer survivors included providing a program that is more accessible to participants in terms of cost, location, and time, partnering with trusted community groups and members to advertise the program and recruit participants, and ensuring PA programs are fun and tailored to emotional needs and physical limitations. Findings from in-depth interviews are summarized in Table 1 and were used to make initial adaptations to the study.

Table 1.

Summary of findings from interviews with community stakeholders and clinicians

Questions/probes from interview guide	Key themes	Quotes
1. Please tell me about the changes that we would need to make to a physical activity program to deliver it in different settings in rural communities. What are some of the changes we would need to make to deliver it within your organization, whether it is a community clinic, church, community center, or other type of place? Probe for information on the culture related to physical activity and psychosocial distress	• Increased education on benefits of exercise/physical activity/wellness • Improved financial accessibility (low-cost or free programs) • Make more accessible based on location • Utilizing churches to get the word out about the program • Little discussion around feelings/emotions	• “I would say, more education on how important the exercise component is because I haven’t heard many people even discuss that with patients.” • “Getting someone to openly admit ‘I need help’ is a really big issue here.” • “We have those advocates that are very passionate about wellness and about movement and about physical activity, and then we have a good portion of the demographic that does not consider that to be important.”
2. What changes would we need to make to ensure participation in a physical activity program as part of a rural cancer survivors’ survivorship plans? Are there physical accommodations that need to be made? Group homogeny, scheduling, types of physical activity, etc.	• Overcoming barriers to insurance coverage and cost (make programs low-cost or free) • Discussions throughout the course of treatment on survivorship plans (physical activity and nutrition) • Increased availability -> greater location accessibility • Make sure that people know program exists • Use social media ads and community members to advocate for the program • Use existing exercise programs with modifications and encourage mind and body activities • Group homogeny can help to make almost anything fun and keep people accountable	• “If people feel a part of something, they’re more likely to return. If it’s fun, they’re more likely to participate. If they feel a sense of community, they’re more likely to advocate for it and be a part of it.” • “Exercise incognito…something that’s just going to not entertain you physically, but it’s also going to entertain you mentally as well.”
3. What do you think some of the barriers are to participation in a physical activity program in a community location? Safety concerns Scheduling Transportation	• Location/proximity • Financial barriers (e.g. time off work, transportation, gas $) • Mental health issues—overcoming negative feelings/emotions • Lack of knowledge about existing programs and/or benefits • Lack of childcare • Few public transit options in rural communities	• “[People] are either mask wearers and shot takers, or they don’t do any of it. There doesn’t seem to be an in-between. It’s either one way or the other. And, you know, that’s probably going to be a very big issue because, you know, for exercising, are you going to social distance everybody? Are you going to make everybody wear masks when they’re trying to exercise? I don’t know if people would do that.”
4. Based on your experience working in rural communities and with cancer survivors, what additional changes would be needed to address the unique physical and psychological needs of rural cancer survivors? Specific characteristics of the intervention Support groups Safety concerns	• Slower paced program • Encourage activities that are part of rural community members’ lives • Include training for team members around emotional components of being a cancer survivor • Provide modifications or adaptive equipment • Consistency in staff members helps with building relationships and leads to a greater feeling of safety	• “Rural communities move at a slower pace than urban communities”

During additional interviews with community partners and clinicians, we identified a trusted community organization and program, Kourage Health (previously known as FitSteps for Life) [31–33], that was already working to promote PA in ­cancer survivors in the Tyler and Northeast Texas area. Kourage Health prescribes medical exercise to patients as a vital part of their cancer care plans and works with physicians to ensure patients are provided a referral for medical exercise at the time of diagnosis to ensure better quality of life and prolonged survival [34–36]. To avoid competing with Kourage Health, we worked with leadership to enhance their existing exercise program to include behavioral skills training and mind-body sessions to better meet the needs of rural breast cancer survivors in the area.

Our feedback session with the CSP included five community scientists from the Tyler and Northeast Texas area, who provided specific feedback on recruitment strategies, working in their rural communities, and challenges our team may face. Additional adaptations and modifications were made to address recruitment challenges and enhance implementation in the Tyler and Northeast Texas area but did not require us to substantively change the intent or conceptual basis for the study. Adaptations made during Phase 1 are summarized in Table 2 by source of intervention adaptation, and the final integrated and adapted intervention was titled Mind Your BEAT (MYB). The final MYB intervention is described in Phase 2 section below along with Table 3 and Fig. 1.

Table 2.

Summary of adaptations made in response to challenges identified by source of intervention adaptation [24]

Source	Challenge identified	Key informantsa	Adaptations made to EBI
Service setting	Use existing programs	RBCS, CPC	Enhanced existing Kourage Health program with components from BEAT Cancer and Harmony and Health
Target audience	Program awareness and recruitment	RBCS, CPC, CSP	Partnered with trusted community organizations, groups, and members to advertise the program and recruit participants
	Modifications offered for exercises	RBCS	Exercise sessions offered a variety of activities (e.g. cardio, strength, core, balance) and modifications provided in exercise and mind-body sessions to accommodate individual needs
Mode of delivery	Group-based vs. individual	RBCS	Options for group-based and one-on-one supervised exercise provided
	Homogenous group	RBCS	Group discussions and mind-body sessions restricted to breast cancer survivors
Cultural adaptations	Program cost and financial barriers	RBCS	Kourage Health provided free of charge to participants from diagnosis through survivorship
	Location and accessibility	RBCS	Exercise sessions offered at 17 locations in the Tyler and Northeast Texas areas and virtually throughout the day to accommodate schedules; all locations have free and convenient parking; mind-body sessions offered at central community location following group-based exercise session
	Integration with rural community life	RBCS, CSP	Participants encouraged to start slow and build their activity over time; exercise sessions are offered at multiple times and locations to better integrate with participants’ schedules; group discussions and mind-body sessions incorporate strategies for integrating exercise and mind-body practices into one’s day
	Building trust with rural residents and community	RBCS, CPC, CSP	Partnered with trusted community organizations, groups, and members to advertise the program, recruit participants, and implement; maintained study presence at local church
Core components	Need increased education on benefits of physical activity and behavioral skills training	RBCS, CPC	Enhanced Kourage Health exercise sessions with group discussions and participant education materials from BEAT Cancer to increase PA
	Flexibility in exercise programming	RBCS	Exercise sessions offered a variety of activities (e.g. cardio, strength, core, balance); modifications provided in exercise and mind-body sessions to accommodate individual needs; options for group-based and one-on-one supervised exercise provided
	Need to address psychosocial wellbeing and distress and include mind-body strategies	RBCS	Enhanced Kourage Health exercise sessions with mind-body sessions (stretching, breathing, and guided relaxation) from Harmony & Health to reduce psychosocial distress

^aKey informants: RBCS, Rural breast cancer survivors; CPC, Community partners and clinicians

Table 3.

Mind Your BEAT group discussion schedule and topics

Week	Topics and theoretical targets	Exercise sessions/week (30 minutes each)	Group discussion and mind-body sessions/week (60 minutes each)	Home-based mind-body sessions/week (30 minutes each)
0	Orientation and introduction to study and participant notebook	0	1 (virtual)	0
1	Introduction to the intervention, goal setting and monitoring, developing an action plan	3	1	1
2		3	0	2
3	Time and stress management (Emotional coping; expectations; perceived barriers; self-efficacy; reciprocal determinism; goal setting)	3	1	1
4		3	0	2
5	Barriers, benefits and safety (Self-efficacy) (barriers); perceived barriers; expectations; social support; environment; enjoyment)	3	1	≥1
6		3	0	2
7	Guest speaker—peer model (Observational learning; self-efficacy)	3	1	≥1
8		3	0	≥2
9	Thinking as the basis for change, barriers, and relapse (Self-efficacy; expectations and value expectancies; environment; goal setting; perceived barriers)	3	1	≥1
10		3	0	≥2
11		3	0	≥2
12		3	0	≥2

Figure 1.

Core components of Mind Your BEAT intervention.

Phase 2: Feasibility Study Protocol for the Adapted Intervention

Methods

Study design and participants

MYB was a 2-arm pilot randomized controlled trial to test the feasibility and preliminary efficacy of a 3-month adapted PA intervention among rural breast cancer survivors. Participants were recruited to the study through the existing Kourage Health program via emails, social media, phone calls, and posted flyers at Kourage Health sites. Additionally, participants were recruited at other community events and venues, including health fairs, church services, breast cancer support groups, and businesses serving cancer survivors. Eligible participants completed written informed consent before completing study activities. All study activities, including assessments and intervention sessions, took place at First Christian Church in Tyler, Texas, and all study procedures and materials were reviewed and approved by the Institutional Review Boards at The University of Texas MD Anderson Cancer Center (protocol ID: 2020-0772) and The University of Texas at Tyler (study ID: 2021-034).

Cancer survivors were screened for eligibility by phone. Potential participants were given a detailed study description and asked for verbal informed consent before screening. Inclusion criteria included: (i) woman at least 18 years of age; (ii) history of ductal carcinoma in situ or Stage I–IIIA breast cancer; (iii) not currently receiving or planning to receive chemotherapy or radiation therapy; (iv) at least 12 weeks postsurgery and treatment; (v) physician clearance to participate in the study; (vi) not meeting PA recommendations (<150 minutes of moderate or greater PA per week during the past 6 months); and (vii) able to read, speak, and write in English. Cancer survivors who were less than 18 years old, had not received a breast cancer diagnosis, were meeting PA recommendations, were not willing to be randomized or attend in-person sessions, or were uncomfortable participating in English were excluded from the study. Potentially eligible participants were scheduled for an in-person baseline assessment and were required to submit physician clearance prior to their assessment or bring the clearance form to their assessment, at which point they were eligible to enroll and completed written informed consent.

Mind Your BEAT intervention

The MYB intervention integrated and adapted core components from three evidence- and theory-based programs, Kourage Health [31–33], BEAT Cancer [25, 37] and Harmony and Health [38, 39], to better meet the needs of rural breast cancer survivors and to aid implementation in a rural community setting. Core components of the intervention were informed by social cognitive theory and are shown in Fig. 1. Table 3 shows a timeline of intervention activities, including sessions and topics by week.

Exercise sessions

MYB participants were instructed to attend at least three 30-minute exercise sessions per week for 12 weeks. Kourage Health offers group-based exercise classes Monday through Friday from 7 a.m. to 3 p.m. Sessions include cardio, strength, core, and balance exercises led by an exercise specialist who has received cancer exercise training and is certified by the American College of Sports Medicine. Participants were also provided the option to attend a one-on-one supervised exercise session with a trained exercise specialist or to join an exercise session virtually via Zoom. Attendance at sessions was monitored by Kourage Health and reported to the study team.

Group discussions and participant education materials

MYB participants also attended six 30-minute in-person group-based discussions during the 12-week intervention period, as shown in Table 3. Sessions were led by a trained study team member and utilized participant education materials (slides, curriculum, and participant notebook) from the BEAT Cancer study [25, 37] and implementation toolkit [40]. Group discussion sessions focused on behavioral skills training and translating cancer specific PA information to cancer survivors. In addition to covering topics such as stress management, time management, and cognitive reframing, group discussions facilitated interactions and support among participants to support behavior change.

Participants were provided a notebook to further support their progress and participation in the discussions and study. Each notebook included the following sections: (i) welcome and role of the health education sessions; (ii) general information such as personnel contact list, locations, and schedules for intervention sessions; (iii) instructions for completing quality control feedback at the end of each session; (iv) exercise-specific information related to intervention goals, exercise safety, healthy nutrition for optimal physical energy, restarting exercise after relapse, stretching guide (photos and instructions), and exercise log sheets; (v) a quality control feedback sheet for each group session; (vi) instructional materials for each group session; (vii) supplemental literature and educational materials; (viii) citations; and (ix) decorative blank pages for journaling.

Mind-body sessions

Mind-body sessions were held in conjunction with the in-person group discussion sessions during the 12-week intervention period, as shown in Table 3. Each 30-minute session included 20 minutes of gentle yoga-based stretching and breathing and 10 minutes of guided relaxation. Participants learned stretches and relaxation strategies during Week 1 and were provided materials to support their home-based practice throughout the study, including a yoga mat, yoga block, yoga belt, list of stretches, detailed description of stretches with pictures, online videos, relaxation tips, daily scriptures, and music recommendations.

Usual care

Participants randomized to usual care were instructed to continue to participate in the Kourage Health program and attend exercise sessions as prescribed by their provider and exercise specialist. Exercise sessions were identical to those available to MYB participants, as described above, and attendance at sessions was monitored by Kourage Health and reported to the study team.

Assessments and randomization

Eligible participants completed in-person assessments at Weeks 0 (baseline), 6 (mid-intervention), 12 (postintervention), and 24 (follow-up). At each assessment, participants completed a physical health assessment, including measured height, weight, resting heart rate, blood pressure, and a 30-second sit-to-stand test, and web-based questionnaires via REDCap. At the end of their assessment, participants received a wrist-worn ActiGraph GT9X accelerometer and were instructed to wear the device during waking hours for 7 consecutive days and to return the device via mail in a self-addressed stamped envelope provided by the research team. Participants were compensated with a retail gift card at the end of each assessment and received additional compensation upon receipt of their accelerometer and verification of wear.

Following receipt of their accelerometer and data verification at baseline, participants were randomized to the MYB intervention or to participate in Kourage Health as usual (usual care) using a minimization randomization procedure, which considered age (<55 or ≥55 years) to reduce imbalances between groups and preserve statistical power [41]. Following randomization, participants were notified of their group assignment and start date via email. All participants were enrolled in the study for 6 months, consisting of a 12-week intervention period and 12-week follow-up period.

Feasibility and acceptability outcomes

The CFIR and RE-AIM Framework guided evaluation of the feasibility and implementation of MYB [26, 27]. A detailed description of indicators and measures mapped onto RE-AIM and CFIR domains and constructs is provided in Table 4. To evaluate the acceptability, appropriateness, feasibility, and adoption of the adapted MYB intervention, we reviewed administrative data, including eligibility, recruitment and retention rates, intervention fidelity, and intervention adherence. Additionally, we conducted in-depth interviews with a subsample of participants (n = 25) and community partners and key informants (n = 10) following the follow-up assessment (Week 24) to evaluate satisfaction with the adapted intervention and implementation outcomes. A semistructured interview guide was used to assess the following: (i) satisfaction with the adapted intervention; (ii) appropriateness of the adapted intervention for rural breast cancer survivors; (iii) feasibility of the adapted intervention in rural community settings; and (iv) perceived adoption of the intervention by delivery agents, organization representatives, and community leaders. Interviews were completed in-person or by phone, digitally recorded, and transcribed. Transcripts were managed using ATLAS.ti (Scientific Software Development GmbH, Berlin, Germany) and coded and analyzed for emergent themes by two independent coders using a thematic content analysis approach [42–44].

Table 4.

RE-AIM and CFIR domains, constructs, indicators and measures, and sources in the Mind Your BEAT study

RE-AIM and CFIR domains	Constructs	Indicators and measures	Data source(s)  a
Reach	Eligibility and exclusion	% screened eligible of those expressing interest; % excluded and characteristics	A
	Recruitment	% individuals who participate out of screened eligible; # contacted, method & yield	A, ICP
	Representativeness	Characteristics of participants compared to nonparticipants and target population	A
Efficacy	Physical activity and psychosocial distress	Changes in physical activity and psychosocial distress	Q, ICS
Adoption	Setting-level	% community orgs/churches approached that participate; characteristics of settings/orgs	A, ICP
	Staff-level	% community leaders interested/participate; characteristics of leaders/nonparticipants	A, ICP
	Delivery agent expertise	Descriptive report of training and experience	A, ICP
Implementation
Outer setting	Participant needs and resources	Awareness of perceived needs and resources available to cancer survivors	ICP
	Cosmopolitanism	The degree to which Kourage Health is networked with other external organizations	ICP
	External incentives	External guidelines and incentives for promoting physical activity among cancer survivors	ICP
Inner setting	Structural characteristics	Kourage Health organization characteristics (size, space, locations, etc.)	ICP
	Networks and communications	Social networks and communication within the organization	ICP
	Culture	The norms and values at Kourage Health	ICP
Characteristics of individuals	Knowledge and beliefs about the intervention	Cancer survivors’ knowledge and beliefs about physical activity	ICS
	Self-efficacy	Cancer survivors’ individua belief in their own capabilities to be physically active and engage in MYB	Q, ICS
	Other personal attributes	Other individual characteristics that may impact physical and emotional wellbeing	Q, ICS
Process	Planning and engaging	Identifying and addressing barriers and facilitators to implementing MYB	ICS, ICP
	Executing	Fidelity checklists to ensure MYB delivered as intended; adherence to reminder calls and % completed	A, C
	Reflecting and evaluating	Time and money costs associated with recruitment, training, and delivery	ICP
Maintenance	Behavior change	Maintenance of behavior change at Week 24	Q, ICS
	Retention and attrition	% retained of enrolled at Weeks 9 and 24; # lost to follow up & differential dropouts	Q, ICS
	Continuation of program	Requests to sustain intervention delivery or institutionalize the program	ICS, ICP

^aData Sources: A, Administrative data (e.g. participant tracking database, Kourage Health client database, Census); C, Checklists; ICS, Interviews with cancer survivors; ICP, Interviews with community partners; Q, Questionnaires.

PA and psychosocial distress outcomes

Changes in PA and psychosocial distress from baseline (Week 0) to postintervention (Week 12) were our primary outcomes of interest. PA is assessed using the Godin Leisure-Time Exercise Questionnaire (LTEQ). The Godin LTEQ includes four items to assess the frequency of strenuous (e.g. running, jogging, squash, and vigorous swimming), moderate (e.g. fast walking, easy bicycling, and dancing), and mild (e.g. yoga, golf, and easy walking) leisure-time exercise during a typical week and during one’s free time (e.g. not during work or for transportation). Although rural residents report greater occupational and household PA than urban residents [45], we chose to focus on leisure-time versus total PA since it is associated with improved health-related quality of life among cancer survivors [7]. The Godin LTEQ has been validated for use in cancer survivors, and weekly leisure-time activity (WLA) scores were used to classify participants as active (≥24) or inactive (<24) [46–48]. Psychosocial distress was assessed using the NCCN Distress Thermometer, which uses a 10-point scale to identify levels of distress, with a score of 0 indicating “no distress” and a score of 10 indicating “extreme distress.” NCCN Distress Thermometer scores were used to classify participants as having low distress (<4) or moderate-to-high distress (≥4) [49].

Additional measures of PA and psychosocial distress along with other outcomes of interest measured at each time point are described in Table 5, and the survey was comparable in length to surveys used in our previous studies and found acceptable among rural cancer survivors [28, 29].

Table 5.

Measures included at each time point in the Mind Your BEAT (MYB) study

Measure	Description	Week 0	Week 6	Week 12	Week 24
Physical activity
Godin leisure-time exercise questionnaire (LTEQ) [47]	The Godin LTEQ includes four items to assess the frequency of strenuous, moderate, and mild leisure-time exercise during a typical week and during one’s free time (e.g. not during work or for transportation). The Godin LTEQ has been validated for use in cancer survivors, and weekly leisure-time activity (WLA) scores were used to classify participants as active (≥24) or inactive (<24) [46–48].	X	X	X	X
[primary outcome]
International physical activity questionnaire (IPAQ)—Long form
Accelerometer-measured physical activity	A wrist-worn ActiGraph GT9X accelerometer (ActiGraph, LLC, Pensacola, FL) was used to measure moderate-to-vigorous physical activity (MVPA). Participants were instructed to wear the device during waking hours for 7 consecutive days. Accelerometer data were collected using a 10 seconds epoch. The criterion for including accelerometer data in analyses was ≥3 days of valid wear, which was defined as ≥10 hours of valid wear time [58, 59] Valid wear time was determined by subtracting nonwear time, defined as ≥20 minutes of consecutive zero counts, from 24 hours. Persons without ≥3 valid days of data were not included in analyses; invalid days were not included in analyses. Raw activity counts were converted to minutes spent doing MVPA using an established cut point for adults [60].	X	X	X	X
Psychosocial distress
NCCN distress thermometer [49]	The NCCN Distress Thermometer uses a 10-point scale to identify levels of distress, with a score of 0 indicating “no distress” and a score of 10 indicating “extreme distress.” Scores were used to classify participants as having low distress (<4) or moderate-to-high distress (≥4) [49]	X	X	X	X
(primary outcome) and problem list
Perceived stress scale (PSS) [61]	Perceived stress was assessed using the 10-item PSS. Scores ranged from 0 to 36, with higher scores indicating greater perceived stress [61].	X	X	X	X
Hospital anxiety and depression scale (HADS) [62]	Anxiety and depression were assessed using the HADS. The HADS includes seven items to measure anxiety and seven items to measure depression, and scores for each subscale range from 0 to 21, with higher scores indicating greater anxiety or depressive symptoms [62]	X	X	X	X
36-item short-form health survey (SF-36) [63]	Health-related quality of life was measured using the 36-item short-form (SF-36), a multipurpose measure of health status [63] The SF-36 measured eight components of health status: physical functioning, role limitations due to physical problems, role limitations due to emotional problems, energy/fatigue, emotional wellbeing, social functioning, pain, and general health. Scores range from 0 to 100, with higher scores indicating a more favorable health status.	X	X	X	X
Potential covariates
Sociodemographics	Age, race, ethnicity, marital status, education, annual household income, and health literacy via the three-item Chew Health Literacy questionnaire [64]	X
Cancer and medical history	Cancer stage, hormone receptor (HR) status, treatment type, time since diagnosis, time since treatment, comorbidities	X
Physical assessment and anthropometrics	Resting heart rate, systolic and diastolic blood pressure, height, weight, calculated BMI, percent body fat via bioelectrical impedance analysis (BIA), 30-second sit-to-stand test [65]	X	X	X	X
Other health behaviors and outcomes or constructs of interest
Dietary intake	Dietary habits, including fruit and vegetable consumption and fat intake, will be assessed using the NIH/NCI Fruit and Vegetable and Fat Screeners. The 19-item Fruit and Vegetable Screener is used to measure daily fruit and vegetable consumption. Fruit and vegetable consumption are reported in terms of frequency and amount consumed over the last month. The 17-item National Cancer Institute’s Fat Screener is used to measure an individual’s usual dietary intake of percent calories from fat; it has good validity (r = 0.64 in men and 0.58 in women) in adults when compared to true intake.	X	X	X	X
Sleep quality	Sleep will be assessed using the Pittsburgh Sleep Quality Index (PSQI), which uses 19 self-rated questions to measure 7 components of sleep, including quality, duration and disturbances.	X	X	X	X
Smoking history and alcohol consumption	Tobacco use and alcohol consumption will be assessed using items from the Behavioral Risk Factor Surveillance System (BRFSS) Questionnaire. Participants will be asked if they have smoked 100 cigarettes in their lifetime, whether they currently smoke every day, some days, or not at all, if they’ve attempted to quit smoking previously, how long it’s been since their last cigarette, and whether they use any other tobacco products (e.g. chewing tobacco, snuff). To assess alcohol use, participants will be asked how many days they drink on average, average number of drinks per day, and binge drinking status.	X	X	X	X
Fatigue symptom inventory (FSI) [66, 67]	The FSI is a 13-item questionnaire designed to measure the intensity and duration of fatigue, one of the most debilitating symptoms of cancer survivors. It has been validated for breast cancer patients as well as healthy populations and has been expanded to male and female cancer patients [66, 67].	X	X	X	X
Satisfaction with life scape (SWLS) [68]	Global quality of life was assessed using the SWLS. The 5-item questionnaire asks individuals to agree or disagree using a 7-point Likert scale and has been validated in diverse populations and age groups [68].	X	X	X	X
Functional assessment of cancer therapy-breast (FACT-B)	The Functional Assessment of Cancer Therapy-Breast (FACT-B) measures health related quality of life in breast cancer patients and has been tested in oncological clinical trials and has been shown to have high validity and reliability.	X	X	X	X
Exercise self-efficacy	Self-efficacy was measured using the Exercise Self-Efficacy Scale, an 18-item scale with answer choices in 10-unit intervals, ranging from 0 (cannot do) to 100 (certainly can do) [69], which has demonstrated high reliability in women [70].	X	X	X	X
Barrier self-efficacy	Barriers self-efficacy (i.e. confidence in ability to overcome barriers) was measured utilizing a 9-item scale specifically designed for breast cancer survivors [71]. The scale asks about confidence overcoming frequently reported barriers to exercise (e.g. “How confident are you that you can exercise when you are tired?”).	X	X	X	X
Social support for physical activity (SSPA) from family and friends	Social support for physical activity was measured using the social support and exercise survey. The survey has 13 items to measure family support and 13 items to measure peer support and has shown high internal consistency and test re-test reliability [72]	X	X	X	X
12-item interpersonal support evaluation list (ISEL-12)	The 12-item Interpersonal Support Evaluation List–12 was used to assess overall perceived social support, which ranges from 0 to 36, with a higher score indicating greater perceived social support [73]	X	X	X	X
Positive and negative affect scale (PANAS)	The 20-item PANAS was used to assess positive and negative affect [74] and scores range from 10 to 50 on each scale. Higher scores on the PANAS indicate higher levels of positive affect and lower scores indicate lower levels of negative affect.	X	X	X	X
Perceived neighborhood environment	The Physical Activity Neighborhood Environment Survey (PANES) was used to measure participants’ self-reported perceptions of their neighborhood environment [75]. The PANES includes 17 items to assess perceptions of the neighborhood environment for walking and cycling, and items are categorized into the following constructs: land use mix, transit access, pedestrian infrastructure, bicycling infrastructure, proximity to recreational facilities, street connectivity, crime safety, traffic safety, pedestrian safety, and aesthetic qualities. The PANES has been shown to have high reliability and content and criterion validity with respective environmental attributes for physical activity [76].	X	X	X	X

Statistical analysis

Preliminary efficacy (proportion of participants reporting low distress on the NCCN Distress Thermometer and classified as active on the Godin LTEQ) was the primary outcome of interest. Separate analyses were completed to assess the proportion of participants reporting low distress and classified as active at postintervention. Intent-to-treat analyses were used, with missing data imputed using modern multiple imputation procedures [50, 51]. NCCN Distress Thermometer scores were used to classify participants as having low distress (<4) or high distress (≥4) [49] and weekly moderate-to-strenuous leisure-time activity scores from the Godin LTEQ were used to classify participants as active (≥24) or inactive (<24) [52–54]. Other measures of PA (e.g. accelerometer-measured minutes of MVPA, self-reported WLA, steps) and psychosocial distress and wellbeing (e.g. perceived stress, anxiety, depression, and quality of life) were examined as secondary outcomes. Primary analyses utilized logistic regression models for the postintervention PA (active, inactive) and distress (low, high) outcomes with the primary predictor being intervention condition (MYB intervention vs. usual care), controlling for selected covariates including demographics and baseline PA or psychosocial distress. Descriptive statistics were used to summarize other outcomes of interest by intervention group. Multiple regression models, repeated measures and mixed effects models were used to examine changes in outcomes over the 6-month study period (Weeks 0–24) and to compare changes between groups.

Sample size and power analysis

The target recruitment goal for this study was 50 rural breast cancer survivors. We aimed to recruit and screen 500 individuals who were interested in participating, anticipating this would yield a final sample size of 50 eligible participants (25 per group). Based on previous data [55], we conservatively expected 7% of participants to drop out before the postintervention assessment (Week 12) and 12% of participants to drop out before the 3-month follow-up assessment (Week 24).

Our sample size justification was based on the precision of the primary analysis of estimating the difference in PA and psychosocial distress between groups (MYB intervention vs. usual care) at postintervention (Weeks 0–12). Based on previous findings [37], we expected to be able to detect a medium effect size of 0.40. An a priori power analysis, assuming a medium effect and a 0.05 two-tailed alpha level, determined that 18 participants per group were needed to achieve 81.5% power. Thus, our sample size of 50 ensured at least 80% power to detect a medium effect.

Results

Recruitment began in June 2022 and was completed in August 2023. The study enrolled and randomized 43 participants to the MYB intervention (n = 22) or usual care (n = 21). Figure 2 shows the study CONSORT diagram through completion of enrollment and randomization. Analyses for feasibility, acceptability, and intervention effects are ongoing and will be reported separately.

Figure 2.

Mind Your BEAT CONSORT diagram.

Discussion

Advances in early detection and cancer treatment combined with more people living longer have resulted in a large and growing number of cancer survivors, which is expected to continue to grow over time [56]. Cancer survivors residing in rural areas have unique physical and psychological needs and fewer programs or options for engaging in PA. Regular PA can help address needs to improve cancer survivorship outcomes and quality of life among rural cancer survivors, but most rural cancer survivors do not meet PA recommendations due to social and environmental contextual barriers. Thus, community-based PA interventions that are tailored to rural cancer survivors’ needs and adapted to address and overcome barriers are needed.

The MYB study was designed to confirm the feasibility of an adapted, community-based intervention and test effects of the adapted intervention on psychosocial distress and leisure-time PA among rural breast cancer survivors. The core intervention components were drawn from three evidence- and theory-based programs, Kourage Health [31–33]. BEAT Cancer [25, 37] and Harmony and Health [38, 39] and were adapted to better meet the needs of rural breast cancer survivors and to aid implementation in a rural community. The intervention was designed with dissemination and implementation in mind, engaging rural breast cancer survivors and trusted clinicians and community leaders in the adaptation process and working with an established community organization to implement the adapted intervention in the community, filling a critical gap in the field on the adaptation and implementation of evidence-based interventions to promote healthy living and improve cancer survivorship in rural communities.

Strengths of the MYB intervention included the use of a staged, community engaged approach to integrate and adapt three evidence-based interventions for rural breast cancer survivors and for implementation in a rural community setting, thereby meeting cancer survivors where they are. This staged process incorporated feedback from a diverse group of community partners and key informants, including medical oncologists, oncology nurses, cooperative extension agents, and rural breast cancer survivors, and ensured that the intervention retained evidence-based core components but was culturally and contextually relevant to the target population. Although the study was designed with dissemination and implementation in mind, the study was not without limitations. We included rural breast cancer survivors residing in Northeast Texas who had access to transportation and were willing to attend in-person sessions at a community location. Therefore, our sample may not have been representative of breast cancer survivors from other rural and remote areas across the United States who may face additional barriers to transportation and access. Most participants in this study were already enrolled in the Kourage Health program. Although enrollment does not guarantee engagement or adoption of the program, they may be more motivated to change their PA behavior than the general cancer survivor population. Lastly, recruitment efforts yielded over 300 interested individuals, but only 25.0% were screened for eligibility. Despite recruiting through trusted community partners and organizations and multiple contact attempts via phone, email, and text, 27.2% of those who expressed initial interest were no longer interested or declined screening and 47.5% were unreachable. Additional work is needed to enhance recruitment efforts among rural cancer survivors to ensure representativeness.

Conclusion

A previous review identified only seven interventions globally that described or evaluated a PA program designed for rural cancer survivors, specifically [57]. MYB aimed to fill this gap by adapting an evidence-based PA behavior change intervention to meet the unique physical and psychosocial needs of rural breast cancer survivors. Adaptation and evaluation of MYB were guided by the combination of the RE-AIM and CFIR frameworks. While the RE-AIM framework was helpful for evaluating effective implementation, in combination with the CFIR, we were also able to identify why implementation succeeded or failed. If successful, findings from this study will contribute to our understanding of how to adapt and implement evidence-based interventions effectively to improve psychosocial distress and PA among rural cancer survivors in rural community settings and will inform a larger randomized controlled trial to confirm intervention efficacy. Furthermore, upon confirming effectiveness, MYB can easily be scaled to other Kourage Health locations across Texas and disseminated to other community centers and settings across the United States. to improve cancer survivorship outcomes and reduce cancer health disparities among rural residents.

Funding Source

This study was funded by the National Institutes of Health, National Cancer Institute (K07CA222335 and P30CA016672). Additional support was provided through a Rising STARs (Science and Technology Acquisition and Retention) Award to Dr Scherezade Mama from The University of Texas System. The funders had no role in the design and conduct of the study; collection, management, analysis, and interpretation of the data; preparation, review, or approval of the manuscript; or decision to submit the manuscript for publication.

Conflicts of Interest

Scherezade K. Mama, Megha Bhatia, Jenna Shia, Kathryn H. Schmitz, Laura Q. Rogers, Trevor Davis, Jennifer Selman, Brittany Murley, Barbara Haas, Joshua M. Smyth, Christopher N. Sciamanna, Stephanie T. Lanza, and Lorna H. McNeill, PhD declare that they have no conflicts of interest.

Human Rights

All procedures performed in studies involving human participants were in accordance with the ethical standards of the institutional and/or national research committee and with the 1964 Helsinki declaration and its later amendments or comparable ethical standards. All study procedures and materials were reviewed and approved by the Institutional Review Boards at The University of Texas MD Anderson Cancer Center (protocol ID: 2020-0772) and The University of Texas at Tyler (study ID: 2021-034).

Informed Consent

Informed consent was obtained from all individual participants included in the study.

Welfare of Animals

This article does not contain any studies with animals performed by any of the authors.

Transparency Statements

Study Registration

This study was not formally registered.

Analytic Plan Pre-Registration

The analysis plan was not formally preregistered.

Analytic Code Availability

There is not analytic code associated with this study.

Materials Availability

Materials used to conduct the study are not publicly available but may be requested by emailing the corresponding author.

Data Availability

De-identified data from this study are not available in a public archive. De-identified data from this study will be made available (as allowable according to institutional IRB standards) by emailing the corresponding author.

Use of AI

Artificial intelligence was not used in the development of this manuscript.