Designing for implementation: planning and evaluation of a clinical exercise oncology program

doi:10.21203/rs.3.rs-2987205/v1

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Designing for implementation: planning and evaluation of a clinical exercise oncology program

https://doi.org/10.21203/rs.3.rs-2987205/v1

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Purpose

This project aimed to design and evaluate an exercise oncology intervention with a long-term goal of integration into standard practice in a local healthcare system.

Methods

This two-phase study used a mixed-methods approach. First, qualitative measures were used to understand the context for exercise integration into oncology care by clinicians and administrators in the healthcare system. Next, the Reach, Effectiveness, Adoption, Implementation, Maintenance (RE-AIM) framework guided a comprehensive evaluation of the exercise service. Reach and Adoption were measured via number of patients enrolled in the program relative to those treated. Adoption was measured via referrals from stakeholders. Implementation was described using the program structure and delivery. Maintenance was described using hospital funding decisions. Effectiveness was assessed using the Bellarmine Norton Assessment Tool (BNAT) and Functional Assessment of Cancer Therapy – Fatigue Scale.

Results

Phase 1 qualitative data suggested critical elements to guide program delivery, including limiting participants to post-primary treatment (surgery, chemotherapy and radiation and streamlining referral process. The Phase 2 evaluation demonstrated suboptimal program reach (2%); significant program effectiveness (improvemed physical function (BNAT; p = 0.05 ) and decreased fatigue (p < 0.05)); receptiveness to program adoption (75%); and strong potential for program maintenance.

Conclusion

Traditional approaches to exercise oncology research trials are not easily integrated into healthcare systems. Designing an exercise program for meaningful integration and sustainment requires understanding the context where the program will be delivered, followed by intentional and continuous engagement with key stakeholders to ensure the program continues to meet the needs of the system.

Implementation

cancer rehabilitation

resistance training

Bellarmine Norton assessment tool

exercise oncology

A mounting body of evidence demonstrating the benefits of exercise on a variety of cancer health-related outcomes (fatigue, quality of life, and physical function) has resulted in governing bodies across the world developing evidence-based exercise guidelines for individuals with cancer.[1–3] As a result, there have been numerous calls to integrate exercise as a part of standard care for individuals with cancer, particularly as a result of evidence demonstrating the association with exercise and reduced recurrence/mortality. [1, 4–7] Despite this, there remains a paucity of effectively implemented evidence-based exercise oncology programs in clinical and community settings. This is supported by the recognition that efficacy studies alone are insufficient to improve public health, and that strategies that identify barriers and facilitators of implementation in real-world settings are critical to moving research into practice.[4, 8–12]

The study of dissemination and implementation of exercise oncology interventions/programs is a critical component for increasing our understanding on how to increase the access to care for people with cancer, and ultimately increase the number of individuals engaging in regular exercise.[4, 6–8] Implementation of interventions in real-world settings requires careful consideration of the intervention components (who delivers it, how are they trained, what is the structure, etc.), the setting in which it will be employed (culture, resources, infrastructure, etc.), along with contextual factors (funding, readiness, attitudes, etc.) influencing the long-term viability for integration and sustainability in practice. [4, 8, 11–15]

The use of implementation science strategies in exercise oncology can complement the research supporting the efficacy of exercise for various cancer treatment-related impairments, and accelerate the translation of exercise oncology evidence into practice. [8, 11] However, while this is a burgeoning area of research, few studies to date have specifically reported on the implementation of exercise oncology interventions in real-world settings. [8] Additionally, to ensure equitable access, it is important to utilize implementation strategies across a variety of settings in cancer care (i.e. academic medical centers, urban vs rural hospital settings) to understand how to develop and deliver exercise oncology initiatives safely to all individuals with cancer. [10, 16]

The Midlands of South Carolina represents a unique model of cancer care to understand factors surrounding the implementation of exercise oncology interventions in community-based, private hospital settings. The majority of cancer care in the Midlands region is split between a large hospital system, Prisma Health – Midlands (PHM), (providing diagnostics and surgery) and a private cancer center, South Carolina Oncology Associates (SCOA) (providing chemotherapy, radiotherapy, hormone therapy, immunotherapy, and allied health services). Though there was interest for an exercise service at PHM, there was no infrastructure to run clinical trials for exercise oncology when this study began. Therefore, the aim of this study was to design and evaluate an exercise oncology intervention with the potential to provide an exercise solution for people receiving oncology care in the Midlands healthcare community, with a long-term goal of integrating it into standard practice.

This study was conducted in collaboration with two local oncology institutions, PHM and SCOA that comprise the majority of cancer care for adults in the Midlands region of South Carolina. Exercise participants signed a written consent prior to study activities. The study was comprised of two phases, 1) pre-integration and 2) evaluation. The first provided insight into the design of the program with an aim to create a sustainable partnership. The second evaluated key points of the program’s implementation and effectiveness. All study activities were reviewed and approved by Prisma Health Midlands Institutional Review Board (Pro00109975).

Stakeholder Advisory Group

A stakeholder advisory group (SAG) was established to develop and guide the project. The SAG included four members: exercise oncology researchers from University of South Carolina (n = 2; authors CF, SH), a rehabilitation clinician and the operations manager of the physical therapy department at the partner oncology organization. SAG members were chosen to provide a mix of people knowledgeable about exercise oncology programming and those familiar with the needs of the local oncology organizations. The SAG met monthly throughout the development phase of the program and at the conclusion of each intervention wave during the implementation phase. (Fig. 1).

Phase 1: Pre-integration

Participants

The SAG members identified key people (n = 5) within the PHM and SCOA to provide perspective on the organizational needs and logistical realities of creating an exercise service for people with cancer. Participants included potential referrers and administration staff with decision making abilities.

Data collection

Qualitative data was collected using semi-structured interviews with the previously identified key stakeholders. Interview questions were designed using the Consolidated Framework for Implementation Research (CFIR) to elicit the stakeholders’ perspectives on the essential contextual factors that may influence implementation outcomes for the service.[17, 18] Participants received an email invitation to participate, with a one-page description of the study and background about the study team. Author CF conducted the interviews via telephone, which lasted ~ 20–35 minutes and were digitally recorded (Zoom, San Jose, CA) and transcribed (Descript, San Francisco, CA). A total of five one-on-one interviews were conducted by one of the PIs (CF).

Phase 2: Evaluation

Participants

The cancer exercise program was offered to individuals who were actively receiving or had completed their primary treatments for cancer. Specifically, intial eligibility criteria included males and females who had completed treatment for any cancer type at either PHM or SCOA, ≥ 18 years of age, stage I-IV. Participants were excluded if they: 1) were unwilling to come to the on-site clinic for exercise sessions 2) had any neuromuscular, cardiovascular, or psychological condition precluding safe exercise; and 3) were unable to read/understand English.

Data Collection

Quantitative Outcomes

Outcomes were selected considering limitations in space, participant burden, and operating in a fully operational physical therapy clinic. Assessments were completed within one week of program initiation and completion, respectively. All assessments (Table 1) have been previously validated within the oncology literature. [19, 20] Participants also completed health information questionaires regarding their demographic, medical and cancer related history, along with source of referral.

Table 1

Battery of Measurements and Techniques Used during Assessments
Measure	Method	Outcomes
Physical function	Bellarmine Norton Assessment Tool (BNAT)	BNAT composite score (sum of scores of 2-minute step test, 30 second sit-stand, timed arm curl and timed up and go).
Self-Reported Fatigue	Self-administered FACIT-Fatigue scale	Self-reported scores across 13-items relating to fatigue and energy in the past 7 days. Lower scores indicate greater fatigue.

Qualitative Outcomes

SAG meeting minutes

The SAG met seven times during the study. Meeting minutes were recorded by study author CF and formed a data set.

Intervention Description

The exercise program was delivered 2 days per week for 8 weeks. The intervention was delivered by graduate and undergraduate exercise science students, under the supervision of one the principal investigators (CF) with extensive experience in the design and delivery of exercise programs for individuals with cancer. Students were required to complete a combination of theory-based learning and practical workshops for coaching individuals with cancer prior to delivering the program. Each session was supervised by a member of the study staff and lasted ~ 60 minutes. A combination of resistance exercise and cardiovascular exercise was tailored to each individual in accordance with their medical/cancer-related history, baseline assessments of physical function, and overall goals. Resistance exercise included 6–8 exercises targeting major muscle groups. The first week of the program was used to familiarize participants to the exercises of the program, provide coaching on safe and appropriate technique, and identifying initial load for 2 sets of 12 repetitions (equivalent to ~ 65% 1 repetition maximum), with a goal of working towards 4 sets of 8 reps. Loading was progressed throughout the program using the ‘2 for 2 rule’, whereby if a participant could complete two additional reps on the last set of an exercise for two consecutive sessions, the weight for an exercise (~ 5–10% for upper body; ~10–15% for lower body) will be increased. Additionally, participants were asked to perform 20–30 minutes of moderate-to-vigorous aerobic activity (approximately 60–85% age-predicted heart rate maximum) via walking, jogging, or cycling each session. A sample of the exercise programming and progression can be found in supplementary file 1. Three 8-week cycles of the exercise program were delivered over the 10-month study period and the program was adapted after each wave as described below (Fig. 1).

Data analysis

Descriptive statistics were used to describe demographic and medical characteristics of participants. Mean and standard deviations are reported for all exploratory outcomes at baseline and 8-week follow up for all participants. Pre-post changes were evaluated using paired t-tests and Cohens d effect sizes were calculated for each outcome. Effect sizes were interpreted as small (d = 0.2), medium (d = 0.5) and large (d = 0.8).[21] Data analyses were conducted using RStudio on a per protocol basis. Qualitative data from interviews and SAG meeting minutes were analyzed using a descriptive approach designed for practitioners and policy makers whereby standard language is used to describe facts without the need for abstract theorizing [25]. A deductive approach to analysis was used, focused on identifying common issues related to the relevant CFIR/RE-AIM construct. Descriptive summaries were created through interpretation of interview transcripts, and SAG meeting minutes. Data analysis was primarily undertaken by MAK with review and input from the other authors. Results are reported descriptively, in-line with each domain/construct of the CFIR and RE-AIM framework.

Phase 1: Pre-integration

Five participants from the partner oncology institutions were interviewed between May and August 2021. One representative from each of the following disciplines participated: social work, physician assistant, oncologist, administrator, data manager. Table 2 includes illustrative quotes from the interviews.

Inner Setting

Culture: Participants described the organization as having a strong commitment to improving the cancer care experience and a willingness to introduce new programs that support this goal.

Intervention

Relative advantage: Participants reported a strong interest in the program and noted that nothing similar was currently available within their organizations.

Design quality: Participants were supportive of the proposed model of exercise delivery (i.e., 8-week program, offered two times per week). Specific recommendations included the target patient population and referral strategies.

Patient population.

While all participants believed in the value of the program, concerns were expressed regarding offering the program to complex patients and those on treatment. A desire to build trust among referring clinicians with an initial focus on a low-risk patient population.

Referral strategies

Participants expressed interest and confidence in facilitating referrals to the program. Several points of referral were suggested (e.g., chemotherapy education nurses prior to treatment, offboarding process with social workers, consults with oncologists); however, all participants expressed the need for a streamlined process that clearly defined eligibility criteria and program details.

Outer Setting

Patient needs and resources: barriers

Cost

While participants were excited a research grant would cover costs of the exercise program for patients, they questioned the program’s potential as a long-term solution for integration without a clear funding stream.

Transportation

Concerns were raised about patients’ ability to access the program due to transportation challenges.

Table 2

Quotes from interview participants
Domain	Quote	Participant type
Inner setting Culture	…always looking at new things, new services, how we can grow as a practice, and really looking at just the best way to service our patients and our members.	Clinician
Intervention Relative advantage	…a dedicated oncology exercise program would be, I think, really helpful. So I think this is a really good idea.	Clinician
	This is the first exercise program anyone has brought to us. It would be the first of its kind.	Administrator
Design quality Patient population	And there are certain populations of patients, um, that just have so many co-morbid conditions and that are stage four, you know? And when your prognosis is limited, Those folks are probably not going to be referred to something like this.	Clinician
	I think we're not going to have as much success recruiting [people on treatment] just because they're just under so much, you know, time, financial, emotional, and physical stress already. It's just hard.	Clinician
Design quality Referral strategies	you're going to have referral cards…you know, the name, your fax numbers so we can get notes to you guys, and then we'll pass those out to the physicians, the mid-level providers, and then the schedulers. So when that opportunity comes up, everything can be streamlined.	Clinician
Outer Setting Patient needs & resources: Cost	Who's going to pay you guys?…in my mind, the true goal would be to create an additional service line, you know, so that it is built into the USC school of medicine service…	Clinician
Patient needs & resources: Transportation	A lot of these patients…don't have rides or transportation… It's just really difficult. [Many] won't make it to the treatment, but then to add in something like [exercise], I just don't see those patients using that.	Clinician
	We have patients that have trouble getting here…if transportation is an issue for somebody who lives close to our facility, getting them to [proposed exercise location] is obviously going to be a problem if they can barely get themselves to treatment.	Administrator

Information gathered through the interviews informed the program’s referral practices and participant eligibility. Specifically, four referral sources were identified: chemotherapy education nurses, nurse practitioners and/or medical oncologists, social workers, and physical therapists. Each referral group received program flyers to post in their offices and provided contact details for the study staff to share with patients. Participant eligibility was initially limited to people who had completed primary treatment (surgery, chemotherapy and radiation) to account for concerns expressed by the clinicians in the interviews.

Phase 2: Evaluation

Reach

During the 9-month recruitment period, 1,275 people received a diagnosis at PHM. Of the 30 participants who were enrolled and completed baseline assessments, 23 completed the exercise program. This represents an overall reach of 2% and a retention rate of 70%. Reasons for withdrawal included personal reasons (3), travel time (1), and unrelated medical concerns (1). One participant withdrew due to muscle soreness following their first exercise session.

Key demographic and medical characteristics of the program participants are outlined in Table 3. The age of participants ranged from 38 to 76 years old. The majority (96%) of exercise participants were female and had a diagnosis of breast cancer (88%). Thirty-two percent (n = 8) of participants were Black and 8% (n = 2) were Asian.

Table 3

Participant Demographics
Demographic Characteristics	Total (N = 25)	Wave 1 (N = 9)	Wave 2 (N = 9)	Wave 3 (N = 7)
Biological Sex
Male	1 (4%)	0	1	0
Female	24 (96%)	9	8	7
Age	60.8 ± 11.5	62.1 ± 12.2	57.3 ± 11.7	63.6 ± 11.1
Height (in.)	64.3 ± 2.8	65.2 ± 2.2	64.7 ± 2.5	62.8 ± 3.6
Weight (lbs.)	169.7 ± 39.2	176.3 ± 45.5	164.7 ± 24.9	167.7 ± 49.6
Ethnicity
White, not of Hispanic origin	15 (60%)	5	6	4
Black / African American	8 (32%)	4	3	1
Asian	2 (8%)	0	0	2
Cancer Types
Breast	22 (88%)	8	8	6
Colorectal	1 (4%)	0	1	0
Cervical	1 (4%)	0	0	1
Melanoma	1 (4%)	1	0	0
Cancer Stage
I	13 (52%)	3	6	4
II	8 (32%)	4	1	3
III	4 (16%)	2	2	0
Treatment Characteristics
Surgery	25 (100%)	9	9	7
Chemotherapy	15 (60%)	6	7	2
Radiotherapy	13 (52%)	5	5	3
Immunotherapy	2 (8%)	1	0	1
Comorbidities
Cardiovascular disease	2 (8%)	0	1	1
Diabetes	4 (16%)	0	1	3
Osteoporosis / osteoarthritis	9 (36%)	2	2	5

Effectiveness

The small sample size and lack of control group precludes any comprehensive analysis/interpretation on changes in the BNAT and fatigue score. However, participants who completed the program experienced significant improvements in cancer-related fatigue (pre: 35.35 ± 11.56, post: 41.78 ± 9.75, p < 0.05; d = 0.60), 2-minute step test (pre: 74.54 ± 19.29, post: 92.65 ± 25.59, p < 0.05; d = 0.80), 30-second sit to stand (pre: 10.88 ± 3.88, post: 13.09 ± 5.10, p = 0.002; d = 0.49), timed arm curl (pre: 13.21 ± 3.45, post: 16.57 ± 4.37, p = 0.000; d = 0.85) and timed up and go (pre: 8.87 ± 3.49, post: 6.79 ± 22.00, p = 0.007; d = 0.74) (Table 4).

Table 4

Effectiveness Outcomes
	Pre	Post	p-value	Cohen’s d
FACIT-F	35.35 ±11.56	41.78±9.75	0.000	0.60
BNAT
Physical Activity	2.79±2.62	3.95±2.20	0.008	0.48
Two-minute Step	74.5±19.29	92.65±25.59	0.000	0.80
30s STS	10.88±3.8	13.09±5.10	0.002	0.49
Arm Curl	13.21±3.45	16.57±4.37	0.000	0.85
TUG	8.87±3.49	6.79±2.00	0.007	0.73
BNAT Total	15.6±3.77	18.38±5.13	0.000	0.62
*BNAT: Bellarmine Norton Assessment Test; FACIT-F: Functional Assessment of Cancer Therapy- Fatigue

Adoption

Referral information revealed three of the four stakeholder groups initially identified adopted the program (i.e. the program received referrals from three of the four groups) (75%), with physical therapists as the most common pathway to the program, representing 60% (n = 18) of all referrals. Additional pathways included oncologists (20%; n = 6), flyers in their oncologist’s office (10%; n = 3), and “other” (10%; n = 3). Notably, the referral pathways became more diverse with each wave. Wave 1 participants (n = 9) were primarily referred by their physical therapist (n = 8; 89%), with only one participant reporting “other” (11%). Of the 11 participants enrolled and baselined during Wave 2, 73% (n = 8) were referred by their physical therapist, while the remaining 27% (n = 3) were referred directly by their oncologist. Ten participants were enrolled in Wave 3. Thirty percent (n = 3) were referred by their oncologist, 30% (n = 3) were recruited by flyers in their doctor’s office, 20% (n = 2) were referred by their physical therapist and the remaining 20% (n = 2) reported “other”.

Implementation

Program funding and delivery: The project was solely funded from a small grant funded through a partnership with the hospital and University. Program decisions were made by the SAG to ensure the program offerings were feasible within the financial constraints of the grant. Specifically, the program was offered using the existing infrastructure of the organization’s physical therapy facilities at two time points in the day: 6.30am – 7.30am and 5.30pm – 6.30pm, Monday through Thursdays. These time slots were chosen to minimize the impact of the program on current clinical operations in the physical therapy clinic.The capacity of this space allowed for four participants per hour. As mentioned above, the principal investigator of the grant (CF), designed and supervised the program. The program was delivered by undergraduate and graduate research assistants supervised by on of the PIs (CF), and who went through training in the area of exercise oncology were responsible for day-to-day program delivery with patients. The funding supported the program to be offered in 3-waves of 8-weeks across 9-months.

Program structure: The program structure (8 weeks; 2 sessions/week) remained consistent across all three waves. However, the model of delivery was changed between waves 1 and 2 in response to participant feedback. The initial program model was delivered in a 1:1 format, with each participant working through their program individually with an exercise professional. Participants expressed a desire for more interaction with other participants. As a result, SAG meeting minutes note a decision to update the delivery model to a group format. Waves 2 and 3 employed a group exercise format, whereby participants were encouraged to exercise together, alternating exercises and stations. In waves 2 and 3, exercise prescription was still individualized and monitored by on-site exercise professionals.

Participant eligibility: Initial program eligibility required that participants had completed primary treatment for their cancer based on concerns raised by clinicians during the pre-implementation phase. SAG meeting minutes clarified that study staff were integrated into the breast tumor board meetings, which took place monthly during the intervention period. Updates about the exercise program were presented to medical oncologists and nurse practitioners at each meeting. Following the second meeting (November 2021), requests were made and subsequently actioned to extend program eligibility to people on primary treatment.

Maintenance

The grant funding support for the exercise program ended in June 2022, after completion of Wave 3. The program could not continue without additional funding. Meeting minutes from the SAG noted the results of a presentation by the study PI (CF) of the program’s preliminary findings to the breast tumor board on January 25th, 2022. The presentation resulted in a decision by the breast tumor board to fund a PhD student to ensure the program could continue. This funding is provided on an annual basis, pending progress reports to the tumor boards, and shifts in funding budget/priorities. Under the supervision of the study PI (CF), this funded PhD student would oversee a team of graduate and undergraduate students responsible for program delivery.

In this study, we used a two-phased approach to design and offer an exercise program for people receiving cancer care in the Midlands region of South Carolina. Our aim was to develop an exercise program that could integrate into standardizes care and be sustained beyond the research trial. In Phase 1, we conducted a needs assessment guided by the CFIR framework to understand the context for exercise integration. The results of the assessment were used to design an exercise program to align with the needs of our partner cancer care organizations. In Phase 2, we conducted an evaluation of the effectiveness and implementation of the exercise program. The evaluation was guided by the RE-AIM framework, spanned 9 months, and included three rounds of an 8-week exercise program. The combined focus on implementation and effectiveness from the start of the project emphasizes the opportunity researchers have to leverage funding to design sustainable solutions for integrating exercise into standard oncology cancer care.

Traditional approaches to clinical research trials are not sufficient to make exercise standard of care, in part because clinical trials have a limited capacity to serve people in the target population.[22, 23] Over nine months our 3-wave trial reached just 2% of the target population. This result is similar to efforts in Australia by Dennett et al [24] and Newton et al [25] where their exercise trials, similarly co-located within cancer treatment centers, achieved a reach of 10% and 12% respectively. A key reason for this low penetration is that trials are designed based on the needs of researchers, not clinicians or organisations. Traditional clinical research trial design requires strict eligibility criteria to ensure quality outcomes. The requirement to target only a select group of people automatically limits the population that can access an exercise service. Moreover, research trials are designed based on grant contracts. Grant limitations often do not allow researchers the funding or time necessary to perform the foundational steps of understanding the needs and capacity of an organization to adopt new programs or practices. As a result, research trials often result in one-off projects and the project groundwork laid is left unused.

Integration of a new program or practice into organizational systems requires delibrate planning [26]. As this trial was the first introduction of exercise research to the Midlands cancer care organizations, several barriers needed to be addressed before patient recruitment could begin. The SAG [27] provided the research team ongoing access to organizational experts to help navigate the system, including identification of key stakeholders to include. The planned pre-integration phase of the project, guided by the CFIR framework [17], provided a comprehensive description of the most critical barriers to adopting exercise into the system. Recognizing the barriers at the outset allowed for the program design to address those challenges. For example, clinician interviews revealed hesitancy to refer specific groups of people (e.g., on active treatment, with co-morbidities) to exercise, which informed the initial study approach to focus on “acceptable” populations. Knowledge of this hesitancy prompted the research team to prioritize opportunities to overcome the noted trust gap between physicians and exercise professionals [28], such as incorporating the research team into tumor board meetings to provide regular updates about the exercise program. These meetings cultivated collective learning and mutual trust between the researchers and clinicians [29], resulting in diverse referrals to the program and set the research team up to secure organizational support to continue the program beyond the initial grant. Cultivating relationships between researchers and organizations offers the potential for long-term collaboration; however, it requires on-going efforts that can be difficult for researchers to prioritize as they are not typically a central focus of once-off projects/trials.

Incorporating implementation questions into traditional effectiveness trials (i.e., hybrid designs [30]) in exercise oncology provides an opportunity for researchers to think beyond the current trial and understand the potential for integration from the outset of a project. The effectiveness outcomes of this trial would have added to the evidence-base describing the positive impact of exercise for people living with and beyond cancer [1].However, the addition of preliminary implementation-focused questions allowed the research team to lay the foundation for future work within the organization. This hybrid approach is emerging within the field of exercise oncology. The first example was provided by Beidas et al. in 2014 [31], though implementation research in the field has gained momentum [10, 14] as calls to provide exercise as a routine part of cancer care have strengthened [6, 7, 32]. Incorporating implementation approaches in exercise oncology research can help researchers leverage short-term funding for longer-term, sustainable projects by providing an understanding of organizational needs [33]. This study is an exemplar. While integration was not achieved, the foundation was laid to develop future collaborations.

Not every exercise oncology research trial requires a dedicated implementation focus, nearly all projects can benefit from understanding the context where they are intended to be delivered. This hybrid approach will set a project up for potential implementation and dissemination. Researchers should include an implementation expert on the research team from the beginning of a project to achieve this goal [34].

A major strength of this study was its hybrid approach, which allowed for the integration of organizational needs into program planning. Additionally, the work was guided by the CFIR and RE-AIM frameworks and used a mixed-methods approach to provide context to the quantitative data. However, the results are limited to one healthcare setting. Important differences may be present in other settings (i.e. academic, community, rural etc.). Finally, consumers with lived experience were not included in the pre-integration phase, though their perspectives were included during the evaluation phase and incorporated into adaptations.

Traditional approaches to exercise oncology research trials are not suffient to close the research to practice gap preventing exercise from moving into standard practice. Integrating into healthcare systems requires deliberate planning. Hybrid implementation-effectiveness approaches to research design present an opportunity to leverage funding to design sustainable solutions.

Funding

This work was supported by the Prisma Health and University of South Carolina Transformative Seed Grant.

Financial Interests

All authors have no relevat financial or non-financial interests to disclose.

Author Contribution

CMF, SEH, MA and JK all contributed to the study conception and design. Material preparation, data collection and analysis were performed by CMF, ARB, ARS, MJ and SEH. The first draft of the manuscript was written by CMF and MAK, and all authors commented on previous versions of the manuscript. All authors read and approved the final manuscript.

Ethics Approval

Approval for this study was granted by Prisma Health Midlands Institutional Review Board (Pro00109975).

Consent to participate

Written informed consent was provided by all participants prior to any study activity.

Consent to publish

n/a

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No competing interests reported.

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Designing for implementation: planning and evaluation of a clinical exercise oncology program

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Abstract

Purpose

Methods

Results

Conclusion

Figures

INTRODUCTION

METHODS

Stakeholder Advisory Group

Phase 1: Pre-integration

Participants

Data collection

Phase 2: Evaluation

Participants

Data Collection

SAG meeting minutes

Intervention Description

Data analysis

RESULTS

Phase 1: Pre-integration

Inner Setting

Intervention

Referral strategies

Phase 2: Evaluation

DISCUSSION

LIMITATIONS

Conclusion

Declarations

References

Additional Declarations

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