Breast Cancer SurvivorSDOTSNCT06671730
Self-Determination Theory-informed Occupational Therapy Program to Increase Physical Activity Among Survivors of Breast Cancer
A study testing 8-Week Telehealth-based Occupational Therapy Program in people with Breast Cancer Survivor, run by University of Oklahoma at 1 site in United States.
Trial summary
We will evaluate a novel 8-week telehealth-delivered occupational therapy (OT) program among breast cancer survivors that seeks to promote engagement in aerobic physical activity (PA) and muscle strengthening exercise (MSE). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Breast Cancer Survivor
- What is being tested?
- 8-Week Telehealth-based Occupational Therapy Program
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 99 participants
- Where
- 1 siteUnited States
- Study dates
- 27 Nov 2024to 29 May 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- ≥18 years old.
- Ability to speak/read English.
- Ability to provide informed consent.
- Having ever received a histologically confirmed diagnosis of invasive breast carcinoma.
- Having undergone breast conserving surgery or mastectomy for BC in the last 24 months.
- Owning a smartphone and/or computer with internet access.
- Willing to participate in once-weekly telehealth-delivered OT sessions for eight weeks.
Who cannot join
- Currently undergoing chemotherapy or radiation as primary cancer treatment.
- Planning or preparing for surgery as primary treatment or as a reconstruction procedure in the next 3 months.
- Presence of distant metastasis.
- Reporting a Physical Activity Readiness Questionnaire (2017 PAR-Q+) score that indicates PA may potentially be unsafe, unless the participant produces a signed doctor's note. We will define 2017 PAR-Q+ scores as indicating that PA may potentially be unsafe as responding "Yes" to any of the follow-up questions except [1] if the individual indicates that they have high blood pressure but subsequent responses indicate that both they do not have problems keeping it under control and that their resting blood pressure is less than 160/90 mmHg, and [2] if the individual indicates that they have a metabolic condition but subsequent responses indicate that they do not have problems controlling their blood sugar levels, do not any experience signs or symptoms of hypoglycemia, and do not have any signs of symptoms of listed diabetes complications).
- Already engaging in ≥ 75 min/week of vigorous-intensity PA, ≥ 150 min/week of moderate-intensity PA, or an equivalent combination of both over the last 3 months.
- Being a prisoner, pregnant, or planning to become pregnant.
- Currently participating in another PA- or OT-based study, or seeking physical therapy or occupational therapy treatment.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Oklahoma Health Sciences
Oklahoma City, Oklahoma, 73104
About this study
Official title: Digitally Mediated Occupational Therapy Program to Increase Physical Activity in Urban and Rural Breast Cancer Survivors Who Have Undergone Breast-conserving Surgery or Mastectomy
We will evaluate a novel 8-week telehealth-delivered occupational therapy (OT) program among breast cancer survivors that seeks to promote engagement in aerobic physical activity (PA) and muscle strengthening exercise (MSE). The telehealth-based delivery of this OT program circumvents some barriers to OT access and participation (e.g., time burden; distance to OT clinic) among breast cancer survivors- particularly important for Oklahoma given that 33% of residents live in rural areas. Additionally, the focus of this program is to promote the preferred aerobic PA and MSE choices of each individual survivor to increase the likelihood of long-term PA engagement. In turn, participants will be more likely to experience the longer-term benefits associated with PA such as improved physical functioning, reduced anxiety, depressive, and pain symptoms, better sleep, and better cardiorespiratory fitness.
Read the detailed description
Breast cancer (BC) survivors, defined as those ever diagnosed with BC through the end of life, totaled approximately 4 million people in the U.S. in 2022. While the 5-year survival rate across all races for BC is 90%, functional limitations associated with BC treatment often have considerable impacts on BC survivors' physical and mental health-related quality of life (HRQoL). Approximately 90% of women diagnosed with non-metastatic BC undergo breast-conserving surgery or mastectomy. These surgical interventions commonly lead to upper extremity impairment, decreased strength, and limited mobility, contributing to long-term declines in objectively measured physical function, one key determinant of HRQoL. Moreover, BC survivors' functional limitations can limit participation in health promoting behaviors (e.g., aerobic physical activity [PA]; muscle strengthening exercise [MSE])-limitations that have been shown to place this population at increased morbidity and premature mortality risk. It is therefore critical to develop accessible programs that allow BC survivors who have undergone breast-conserving surgery or mastectomy to reduce functional limitations and more readily engage in health promoting behaviors contributing to improved HQRoL.
Physical activity is safe and beneficial for most cancer survivors, and can improve HRQoL via increased self-efficacy and physical, emotional, social, and functional well-being. More specifically, aerobic PA has been shown to have a positive impact on multiple aspects of BC survivors' health, including cardiorespiratory fitness and fatigue levels. Recently, MSE has been established as a critical health-promoting behavior for reducing the functional limitations associated with BC treatment. MSE also contributes to improved cardiorespiratory fitness and overall metabolic health. However, less than 20% of BC survivors meet recommended aerobic PA and MSE guidelines. Qualitative research highlights that BC survivors who have undergone breast-conserving surgery or mastectomy are uncertain about integrating aerobic PA and MSE into their lives after transitioning out of formal care settings. Support is needed to help this population with lingering functional limitations transition into sustained, self-directed PA and MSE in community- and home-based settings.
Occupational therapy (OT) is uniquely capable of addressing the barriers to sustained PA faced by BC survivors who have undergone breast-conserving surgery or mastectomy. The goal of OT for cancer survivors is to return to activities of daily living following cancer treatment. As such, OT is a critical post-treatment component for BC survivors. Occupational therapists are trained in behavior change techniques, remediation of functional impairments, and modification of activities and environments. This training uniquely positions occupational therapists to provide the specialized aerobic PA and MSE programming that can support BC survivors' health behavior initiation and maintenance. Further, this skillset may be particularly conducive to promoting long-term adherence to aerobic PA and MSE, as OT emphasizes the primacy of building clients' capacity to engage in behaviors that are congruent with personally held values and preferences. Emerging evidence suggests that orienting health promotion efforts in this way supports sustained lifestyle behavior change.
OT-based PA programming for BC survivors can be grounded in Self-Determination Theory (SDT) to support sustained, self-directed PA. SDT posits that people are oriented toward growth and development, and that the satisfaction of people's core psychological needs (i.e., autonomy, competence, and relatedness) facilitates the formation of autonomous motivations for health-related behaviors (i.e., enjoyment, interest, identity, and values). It theorizes that changes in more autonomous motivations will yield longer-lasting behavioral changes than changes in less autonomous motivations. Autonomous motivations for PA are well established determinants of long-term physical activity maintenance in multiple populations, including BC survivors. Autonomous motivations for PA can be modified by targeting core psychological needs (i.e., increasing perceptions of autonomy, competence, and relatedness). Importantly, SDT has been proposed as an ideal theoretical framework for guiding OT. OT is centered on building client's capacity to engage in personally defined goals and occupations (targeting perceptions of autonomy). Occupational therapists scaffold learning and apply therapeutic techniques centered on helping clients experience incremental successes toward achieving their goals (competence); they also prioritize establishing an autonomy-supportive, therapeutic alliance with their clients (relatedness). It is through these mechanisms of action that we expect our program to yield sustained increases in aerobic PA/MSE for BC survivors.
Digitally mediated occupational therapy (OT) is uniquely suited to helping BC survivors transition to sustained community- and home-based physical activity after undergoing breast surgery dramatically increasing the accessibility of expert-provided PA/MSE programing. OT programs conducted in formal settings are often associated with low adherence and face marked barriers to implementation, including lack of access to care and transportation-related barriers. These barriers are most pronounced in rural BC survivors-particularly relevant to the target population of the current proposal; in 2020, 33% of Oklahomans lived in areas designated as 'rural' by the U.S. Department of Agriculture (USDA) Economic Research Service (ERS). The use of digital technologies, such as telehealth, can help rural and urban BC survivors circumvent these challenges to receiving OT programming. Emerging evidence suggests that technology-mediated OT is feasible for urban and rural BC survivors. Yet, more research is needed to understand if a telehealth-delivered OT program based on the tenets of SDT and focused on promoting post-surgery aerobic PA and MSE will be acceptable and feasible to urban and rural BC survivors. We propose to investigate the acceptability, feasibility, and safety of a novel 8-week OT program among urban and rural BC survivors (N = 30) that combines 1) 8 telehealth-delivered sessions with an occupational therapist and 2) self-regulatory strategies known to support PA adoption and maintenance.1 Study observations will contribute valuable insights regarding how to scale telehealth-delivered OT programs to improve PA adherence and PROs among urban and rural BC survivors-ultimately helping improve HRQoL.
We will investigate the acceptability and feasibility of a novel 8-week OT program among 30 rural and urban BC survivors that features: 1) 8 weekly telehealth OT sessions, and 2) self-regulatory strategies known to support aerobic PA and MSE adoption and maintenance, emphasizing components of the SDT, and the provision of a wearable device (e.g., a fitness tracker) programmed to supplement individually tailored goals. We have the following Specific Aims, Hypotheses, and Milestones:
Aim 1: Assess participants' perceptions of the acceptability, usability, and usefulness of the SDT-grounded, OT-based PA/MSE program (hereafter 'program'). Hypothesis 1: Participants will report the program's components to be acceptable, useable, and useful. Milestone 1a: Thematic analyses of qualitative data will suggest the program was enjoyable and improved physical and mental well-being. Milestone 1b: Quantitative assessments of the program via the System Usability Scale will average scores >68-indicative of 'above-average' program usability and usefulness.
Aim 2: Evaluate program feasibility and safety. Hypothesis 2: The program will be feasible and safe as demonstrated by satisfactory participant retention and adherence to program components and no unexpected increases in adverse outcomes. Milestone 2a: At least 80% of participants who complete baseline measures will subsequently complete post-program measures Milestone 2b: Participants will average ≥80% attendance at OT sessions. Milestone 2c: Frequency of BC-related lymphedema, musculoskeletal injuries, and any adverse events will be below normative values-indicative of a safe program.
Exploratory Aims: Evaluate pre- to post-program changes in 1: SDT-related constructs as key mechanisms of action; 2: aerobic PA and MSE; and 3: patient-reported outcomes (PROs) and goal attainment. Exploratory Hypotheses: Pre- to post-program changes in SDT-related components, aerobic PA and MSE behaviors, and PROs/goal attainment will be favorable. Milestone 3a: Measures of perceived autonomy, competence, and relatedness-key SDT components in the context of PA/MSE-will improve from pre- to post-program. Milestone 3b: Participants will demonstrate aerobic PA increase of ≥10 minutes/day and will engage in at least two MSE bout per week by post-program. Milestone 3c: An average pre- to post-program change of 2-6 T-score points, dependent on the PRO being assessed, as measured by the Patient-Reported Outcomes Measurement Information System (PROMIS), with most participants achieving their pre-program goals by post-program.
- Conditions
- Breast Cancer Survivor
- Being tested
- 8-Week Telehealth-based Occupational Therapy Program
- Keywords
- Aerobic Physical Activity, Muscle Strengthening Exercise, Patient Reported Outcomes, Feasibility, Acceptability, Wearable Devices, Telehealth
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
8-Week Telehealth-based Occupational Therapy ProgramBehavioural
The telehealth-based OT program will be grounded in SDT. The program will be designed to help BC survivors transition from recovery after surgery to achieving levels of aerobic PA and MSE that are recommended according to each participants' specific treatment course and desired outcomes. Participants will engage in eight once-weekly OT sessions with a licensed occupational therapist via Zoom-lasting for up to about an hour. Each session will teach psychoeducational and skill-building techniques that support decreasing functional limitations associated with BC and BC treatment as well as improving behavioral skill sets necessary for maintenance of aerobic PA and MSE. Participants will receive study-provided exercise equipment and a fitness tracker (Fitbit Charge 6) for use engaging in greater amounts of aerobic PA and MSE (keeping these materials post-study)
| Study group | Role | What they receive |
|---|---|---|
| 8-Week Telehealth-delivered Occupational Therapy Program | Experimental | The telehealth-based OT program will be grounded in SDT. The program will be designed to help BC survivors transition from recovery after surgery to achieving levels of aerobic PA and MSE that are recommended according to each participants' specific treatment course and desired outcomes. Participants will engage in eight once-weekly OT sessions with a licensed occupational therapist via Zoom-lasting for up to about an hour. Each session will teach psychoeducational and skill-building techniques that support decreasing functional limitations associated with BC and BC treatment as well as improving behavioral skill sets necessary for maintenance of aerobic PA and MSE. Participants will receive study-provided exercise equipment and a fitness tracker (Fitbit Charge 6) for use engaging in greater amounts of aerobic PA and MSE (keeping these materials post-study). Receives: Behavioral: 8-Week Telehealth-based Occupational Therapy Program |
What is being measured
The primary outcome is the main question the study is designed to answer.
Program Acceptability
Semi-structured Interviews and face valid questionnaires will be used to determine whether BC survivors found the intervention acceptable. The semi-structured interviews will be evaluated via thematic analysis, and the questionnaires will be scored on a 7-point Likert scale (1: 'Not at all'; 7: 'Very'), with higher scores being better.
Measured: End of Study Week 8
Program Usability
Semi-structured interviews and face valid questionnaires will be used to determine whether BC survivors found the intervention useful as well as how it could be improved in the future. The semi-structured interviews will be evaluated via thematic analysis, and the questionnaires will be scored on a 7-point Likert scale (1: 'Not at all'; 7: 'Very'), with higher scores being better.
Measured: End of Study Week 8
Program Usefulness
Semi-structured Interviews and face valid questionnaires will be used to determine whether BC survivors found the intervention useful at helping them increase their ability to engage in PAs that they value most. The semi-structured interviews will be evaluated via thematic analysis, and the questionnaires will be scored on a 7-point Likert scale (1: 'Not at all'; 7: 'Very'), with higher scores being better.
Measured: End of Study Week 8
Secondary outcomes (4)
Feasibility: Program Recruitment
Recruitment rates will be reported as the proportion of BC survivors enrolled in the study divided by the number of BC survivors who complete the screening survey. Enrollment will be considered feasible if ≥70% of eligible and approached BC survivors consent and enroll.
Measured: From Baseline through Study Week 8
Feasibility: Program Retention
Study retention will be the number of BC survivors completing the program divided by the number that started. Retention will be considered feasible if ≥80% BC survivors who complete the baseline measures also complete measures post-program.
Measured: From Baseline through Study Week 8
Feasibility: Program Adherence
The number of weekly telehealth-delivered OT sessions (out of eight total sessions) that each participant attends will be used as the program adherence metric. Adherence will be considered feasible if participants average ≥80% attendance OT sessions.
Measured: From Baseline through Study Week 8
Program Safety: Incidence of Lymphedema Events, Musculoskeletal Injuries, and Adverse Events
Assessments of program safety will be assessed by tracking any BC-related lymphedema events, musculoskeletal injuries, and adverse events. The occupational therapist will track this information each week during each participant's telehealth-delivered OT session. The program will be considered safe if these events occur at or below published normative values.
Measured: From Baseline through Study Week 8
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Nov 2024
- Study start27 Nov 2024
- Primary completion29 May 2026
- Study completion29 May 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Breast Cancer SurvivorStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- We will investigate the acceptability and feasibility of a novel 8-week occupational therapy (OT) program among 38 rural and urban breast cancer (BC) survivors that features: 1) 8 weekly telehealth OT sessions, and 2) self-regulatory strategies known to support aerobic physical activity (PA) and muscle strengthening exercise (MSE) adoption and maintenance, emphasizing components of the Self-Determination Theory (SDT), and the provision of a wearable device (e.g., a fitness tracker) programmed to supplement individually tailored goals.
- Masking
- None (open label)
- Enrolment
- 99 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Oklahoma
- Sponsor type
- University, hospital or other
- Collaborators
- American Cancer Society, Inc.
- Responsible party
- Sponsor
- Investigators
- Tara C Klinedinst, PhD, Principal investigator, University of Oklahoma Health SciencesMichael C Robertson, PhD, MPH, Principal investigator, University of Oklahoma Health SciencesZachary C Pope, PhD, Principal investigator, University of Oklahoma Health Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06671730
- Sponsor's protocol ID
- 16601P
- Other IDs
- IRG-23-1143225-04-IRG
- Acronym
- SDOTS
- Status last verified
- Aug 2026
- First submitted
- 31 Oct 2024
- Last updated
- 19 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Klinedinst TC, Pope ZC, Robertson MC, Stanley N, Wint A, Henson C, Kendzor DE. Digitally Mediated Occupational Therapy to Increase Physical Activity in Urban and Rural Breast Cancer Survivors: Protocol for a Single-Arm Feasibility Trial. JMIR Res Protoc. 2025 Sep 26;14:e73554. doi: 10.2196/73554.
PubMed 41004800
Study at a glance
From the registry record, last updated by the sponsor on 19 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Digitally Mediated Occupational Therapy Program to Increase Physical Activity in Urban and Rural Breast Cancer Survivors Who Have Undergone Breast-conserving Surgery or Mastectomy
- ClinicalTrials.gov ID
- NCT06671730
- Acronym / sponsor ID
- SDOTS / 16601P
- Conditions
- Breast Cancer Survivor
- Keywords
- Aerobic Physical Activity, Muscle Strengthening Exercise, Patient Reported Outcomes, Feasibility, Acceptability, Wearable Devices, Telehealth
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 99 participants (actual)
- Lead sponsor
- University of OklahomaUniversity, hospital or other
- Collaborators
- American Cancer Society, Inc.
- Study start
- 27 Nov 2024 (actual)
- Primary completion
- 29 May 2026 (actual)
- Study completion
- 29 May 2026 (actual)
- First posted
- 4 Nov 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
We will evaluate a novel 8-week telehealth-delivered occupational therapy (OT) program among breast cancer survivors that seeks to promote engagement in aerobic physical activity (PA) and muscle strengthening exercise (MSE). The telehealth-based delivery of this OT program circumvents some barriers to OT access and participation (e.g., time burden; distance to OT clinic) among breast cancer survivors- particularly important for Oklahoma given that 33% of residents live in rural areas. Additionally, the focus of this program is to promote the preferred aerobic PA and MSE choices of each individual survivor to increase the likelihood of long-term PA engagement. In turn, participants will be more likely to experience the longer-term benefits associated with PA such as improved physical functioning, reduced anxiety, depressive, and pain symptoms, better sleep, and better cardiorespiratory fitness.
Detailed description
Breast cancer (BC) survivors, defined as those ever diagnosed with BC through the end of life, totaled approximately 4 million people in the U.S. in 2022. While the 5-year survival rate across all races for BC is 90%, functional limitations associated with BC treatment often have considerable impacts on BC survivors' physical and mental health-related quality of life (HRQoL). Approximately 90% of women diagnosed with non-metastatic BC undergo breast-conserving surgery or mastectomy. These surgical interventions commonly lead to upper extremity impairment, decreased strength, and limited mobility, contributing to long-term declines in objectively measured physical function, one key determinant of HRQoL. Moreover, BC survivors' functional limitations can limit participation in health promoting behaviors (e.g., aerobic physical activity [PA]; muscle strengthening exercise [MSE])-limitations that have been shown to place this population at increased morbidity and premature mortality risk. It is therefore critical to develop accessible programs that allow BC survivors who have undergone breast-conserving surgery or mastectomy to reduce functional limitations and more readily engage in health promoting behaviors contributing to improved HQRoL.
Physical activity is safe and beneficial for most cancer survivors, and can improve HRQoL via increased self-efficacy and physical, emotional, social, and functional well-being. More specifically, aerobic PA has been shown to have a positive impact on multiple aspects of BC survivors' health, including cardiorespiratory fitness and fatigue levels. Recently, MSE has been established as a critical health-promoting behavior for reducing the functional limitations associated with BC treatment. MSE also contributes to improved cardiorespiratory fitness and overall metabolic health. However, less than 20% of BC survivors meet recommended aerobic PA and MSE guidelines. Qualitative research highlights that BC survivors who have undergone breast-conserving surgery or mastectomy are uncertain about integrating aerobic PA and MSE into their lives after transitioning out of formal care settings. Support is needed to help this population with lingering functional limitations transition into sustained, self-directed PA and MSE in community- and home-based settings.
Occupational therapy (OT) is uniquely capable of addressing the barriers to sustained PA faced by BC survivors who have undergone breast-conserving surgery or mastectomy. The goal of OT for cancer survivors is to return to activities of daily living following cancer treatment. As such, OT is a critical post-treatment component for BC survivors. Occupational therapists are trained in behavior change techniques, remediation of functional impairments, and modification of activities and environments. This training uniquely positions occupational therapists to provide the specialized aerobic PA and MSE programming that can support BC survivors' health behavior initiation and maintenance. Further, this skillset may be particularly conducive to promoting long-term adherence to aerobic PA and MSE, as OT emphasizes the primacy of building clients' capacity to engage in behaviors that are congruent with personally held values and preferences. Emerging evidence suggests that orienting health promotion efforts in this way supports sustained lifestyle behavior change.
OT-based PA programming for BC survivors can be grounded in Self-Determination Theory (SDT) to support sustained, self-directed PA. SDT posits that people are oriented toward growth and development, and that the satisfaction of people's core psychological needs (i.e., autonomy, competence, and relatedness) facilitates the formation of autonomous motivations for health-related behaviors (i.e., enjoyment, interest, identity, and values). It theorizes that changes in more autonomous motivations will yield longer-lasting behavioral changes than changes in less autonomous motivations. Autonomous motivations for PA are well established determinants of long-term physical activity maintenance in multiple populations, including BC survivors. Autonomous motivations for PA can be modified by targeting core psychological needs (i.e., increasing perceptions of autonomy, competence, and relatedness). Importantly, SDT has been proposed as an ideal theoretical framework for guiding OT. OT is centered on building client's capacity to engage in personally defined goals and occupations (targeting perceptions of autonomy). Occupational therapists scaffold learning and apply therapeutic techniques centered on helping clients experience incremental successes toward achieving their goals (competence); they also prioritize establishing an autonomy-supportive, therapeutic alliance with their clients (relatedness). It is through these mechanisms of action that we expect our program to yield sustained increases in aerobic PA/MSE for BC survivors.
Digitally mediated occupational therapy (OT) is uniquely suited to helping BC survivors transition to sustained community- and home-based physical activity after undergoing breast surgery dramatically increasing the accessibility of expert-provided PA/MSE programing. OT programs conducted in formal settings are often associated with low adherence and face marked barriers to implementation, including lack of access to care and transportation-related barriers. These barriers are most pronounced in rural BC survivors-particularly relevant to the target population of the current proposal; in 2020, 33% of Oklahomans lived in areas designated as 'rural' by the U.S. Department of Agriculture (USDA) Economic Research Service (ERS). The use of digital technologies, such as telehealth, can help rural and urban BC survivors circumvent these challenges to receiving OT programming. Emerging evidence suggests that technology-mediated OT is feasible for urban and rural BC survivors. Yet, more research is needed to understand if a telehealth-delivered OT program based on the tenets of SDT and focused on promoting post-surgery aerobic PA and MSE will be acceptable and feasible to urban and rural BC survivors. We propose to investigate the acceptability, feasibility, and safety of a novel 8-week OT program among urban and rural BC survivors (N = 30) that combines 1) 8 telehealth-delivered sessions with an occupational therapist and 2) self-regulatory strategies known to support PA adoption and maintenance.1 Study observations will contribute valuable insights regarding how to scale telehealth-delivered OT programs to improve PA adherence and PROs among urban and rural BC survivors-ultimately helping improve HRQoL.
We will investigate the acceptability and feasibility of a novel 8-week OT program among 30 rural and urban BC survivors that features: 1) 8 weekly telehealth OT sessions, and 2) self-regulatory strategies known to support aerobic PA and MSE adoption and maintenance, emphasizing components of the SDT, and the provision of a wearable device (e.g., a fitness tracker) programmed to supplement individually tailored goals. We have the following Specific Aims, Hypotheses, and Milestones:
Aim 1: Assess participants' perceptions of the acceptability, usability, and usefulness of the SDT-grounded, OT-based PA/MSE program (hereafter 'program'). Hypothesis 1: Participants will report the program's components to be acceptable, useable, and useful. Milestone 1a: Thematic analyses of qualitative data will suggest the program was enjoyable and improved physical and mental well-being. Milestone 1b: Quantitative assessments of the program via the System Usability Scale will average scores >68-indicative of 'above-average' program usability and usefulness.
Aim 2: Evaluate program feasibility and safety. Hypothesis 2: The program will be feasible and safe as demonstrated by satisfactory participant retention and adherence to program components and no unexpected increases in adverse outcomes. Milestone 2a: At least 80% of participants who complete baseline measures will subsequently complete post-program measures Milestone 2b: Participants will average ≥80% attendance at OT sessions. Milestone 2c: Frequency of BC-related lymphedema, musculoskeletal injuries, and any adverse events will be below normative values-indicative of a safe program.
Exploratory Aims: Evaluate pre- to post-program changes in 1: SDT-related constructs as key mechanisms of action; 2: aerobic PA and MSE; and 3: patient-reported outcomes (PROs) and goal attainment. Exploratory Hypotheses: Pre- to post-program changes in SDT-related components, aerobic PA and MSE behaviors, and PROs/goal attainment will be favorable. Milestone 3a: Measures of perceived autonomy, competence, and relatedness-key SDT components in the context of PA/MSE-will improve from pre- to post-program. Milestone 3b: Participants will demonstrate aerobic PA increase of ≥10 minutes/day and will engage in at least two MSE bout per week by post-program. Milestone 3c: An average pre- to post-program change of 2-6 T-score points, dependent on the PRO being assessed, as measured by the Patient-Reported Outcomes Measurement Information System (PROMIS), with most participants achieving their pre-program goals by post-program.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- We will investigate the acceptability and feasibility of a novel 8-week occupational therapy (OT) program among 38 rural and urban breast cancer (BC) survivors that features: 1) 8 weekly telehealth OT sessions, and 2) self-regulatory strategies known to support aerobic physical activity (PA) and muscle strengthening exercise (MSE) adoption and maintenance, emphasizing components of the Self-Determination Theory (SDT), and the provision of a wearable device (e.g., a fitness tracker) programmed to supplement individually tailored goals.
| Arm | Type | Receives |
|---|---|---|
| 8-Week Telehealth-delivered Occupational Therapy Program | Experimental | Behavioral: 8-Week Telehealth-based Occupational Therapy ProgramThe telehealth-based OT program will be grounded in SDT. The program will be designed to help BC survivors transition from recovery after surgery to achieving levels of aerobic PA and MSE that are recommended according to each participants' specific treatment course and desired outcomes. Participants will engage in eight once-weekly OT sessions with a licensed occupational therapist via Zoom-lasting for up to about an hour. Each session will teach psychoeducational and skill-building techniques that support decreasing functional limitations associated with BC and BC treatment as well as improving behavioral skill sets necessary for maintenance of aerobic PA and MSE. Participants will receive study-provided exercise equipment and a fitness tracker (Fitbit Charge 6) for use engaging in greater amounts of aerobic PA and MSE (keeping these materials post-study). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- ≥18 years old.
- Ability to speak/read English.
- Ability to provide informed consent.
- Having ever received a histologically confirmed diagnosis of invasive breast carcinoma.
- Having undergone breast conserving surgery or mastectomy for BC in the last 24 months.
Key exclusion criteria (7 listed)
- Currently undergoing chemotherapy or radiation as primary cancer treatment.
- Planning or preparing for surgery as primary treatment or as a reconstruction procedure in the next 3 months.
- Presence of distant metastasis.
- Reporting a Physical Activity Readiness Questionnaire (2017 PAR-Q+) score that indicates PA may potentially be unsafe, unless the participant produces a signed doctor's note. We will define 2017 PAR-Q+ scores as indicating that PA may potentially be unsafe as responding "Yes" to any of the follow-up questions except [1] if the individual indicates that they have high blood pressure but subsequent responses indicate that both they do not have problems keeping it under control and that their resting blood pressure is less than 160/90 mmHg, and [2] if the individual indicates that they have a metabolic condition but subsequent responses indicate that they do not have problems controlling their blood sugar levels, do not any experience signs or symptoms of hypoglycemia, and do not have any signs of symptoms of listed diabetes complications).
- Already engaging in ≥ 75 min/week of vigorous-intensity PA, ≥ 150 min/week of moderate-intensity PA, or an equivalent combination of both over the last 3 months.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 8-Week Telehealth-based Occupational Therapy ProgramThe telehealth-based OT program will be grounded in SDT. The program will be designed to help BC survivors transition from recovery after surgery to achieving levels of aerobic PA and MSE that are recommended according to each participants' specific treatment course and desired outcomes. Participants will engage in eight once-weekly OT sessions with a licensed occupational therapist via Zoom-lasting for up to about an hour. Each session will teach psychoeducational and skill-building techniques that support decreasing functional limitations associated with BC and BC treatment as well as improving behavioral skill sets necessary for maintenance of aerobic PA and MSE. Participants will receive study-provided exercise equipment and a fitness tracker (Fitbit Charge 6) for use engaging in greater amounts of aerobic PA and MSE (keeping these materials post-study) | Behavioural | 8-Week Telehealth-delivered Occupational Therapy Program |
Primary outcome
Program Acceptability
Time frame: End of Study Week 8
Semi-structured Interviews and face valid questionnaires will be used to determine whether BC survivors found the intervention acceptable. The semi-structured interviews will be evaluated via thematic analysis, and the questionnaires will be scored on a 7-point Likert scale (1: 'Not at all'; 7: 'Very'), with higher scores being better.
Program Usability
Time frame: End of Study Week 8
Semi-structured interviews and face valid questionnaires will be used to determine whether BC survivors found the intervention useful as well as how it could be improved in the future. The semi-structured interviews will be evaluated via thematic analysis, and the questionnaires will be scored on a 7-point Likert scale (1: 'Not at all'; 7: 'Very'), with higher scores being better.
Program Usefulness
Time frame: End of Study Week 8
Semi-structured Interviews and face valid questionnaires will be used to determine whether BC survivors found the intervention useful at helping them increase their ability to engage in PAs that they value most. The semi-structured interviews will be evaluated via thematic analysis, and the questionnaires will be scored on a 7-point Likert scale (1: 'Not at all'; 7: 'Very'), with higher scores being better.
4 secondary outcomes
Feasibility: Program Recruitment
Time frame: From Baseline through Study Week 8
Feasibility: Program Retention
Time frame: From Baseline through Study Week 8
Feasibility: Program Adherence
Time frame: From Baseline through Study Week 8
Program Safety: Incidence of Lymphedema Events, Musculoskeletal Injuries, and Adverse Events
Time frame: From Baseline through Study Week 8
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Aug 2026.
- Derived from this study: PubMed 41004800Klinedinst TC, Pope ZC, Robertson MC, Stanley N, Wint A, Henson C, Kendzor DE. Digitally Mediated Occupational Therapy to Increase Physical Activity in Urban and Rural Breast Cancer Survivors: Protocol for a Single-Arm Feasibility Trial. JMIR Res Protoc. 2025 Sep 26;14:e73554. doi: 10.2196/73554.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Tara C Klinedinst, PhD principal investigator
University of Oklahoma Health Sciences
Michael C Robertson, PhD, MPH principal investigator
University of Oklahoma Health Sciences
Zachary C Pope, PhD principal investigator
University of Oklahoma Health Sciences
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 8-Week Telehealth-based Occupational Therapy Program in people with Breast Cancer Survivor, run by University of Oklahoma at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Program Acceptability (time frame: End of Study Week 8). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06671730, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Aug 2026.