Self-Determination Theory-informed Occupational Therapy Program to Increase Physical Activity Among Survivors of Breast Cancer

NCT06671730 | Recruiting

• 2 other identifiers: 16601PIRG-23-1143225-04-IRG
• Study Type: interventional
• Target: 38
• Locations: 1 country
• Sites: 1

Brief 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). 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.

Conditions

Breast Cancer Survivor

Keywords

Aerobic Physical Activity; Muscle Strengthening Exercise; Patient Reported Outcomes; Feasibility; Acceptability; Wearable Devices; Telehealth

Outcome Measures

Primary Outcomes (3)

• 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.

  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.

  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.

  End of Study Week 8

Secondary Outcomes (4)

• Feasibility: Program Recruitment

  From Baseline through Study Week 8

• Feasibility: Program Retention

  From Baseline through Study Week 8

• Feasibility: Program Adherence

  From Baseline through Study Week 8

• Program Safety: Incidence of Lymphedema Events, Musculoskeletal Injuries, and Adverse Events

  From Baseline through Study Week 8

Other Outcomes (8)

• Psychological Needs Satisfaction

  From Baseline through Study Week 8

• Theory Intervention Fidelity Test

  End of Study Week 8

• Supportive Accountability Inventory

  End of Study Week 8

Study Arms (1)

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).

Behavioral: 8-Week Telehealth-based Occupational Therapy Program

Interventions

8-Week Telehealth-based Occupational Therapy Program BEHAVIORAL

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)

8-Week Telehealth-delivered Occupational Therapy Program

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• ≥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 12 months.
• Owning a smartphone and/or computer with internet access.
• Willing to participate in once-weekly telehealth-delivered OT sessions for eight weeks.

You may not qualify if:

• 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.

Sponsors & Collaborators

• American Cancer Society, Inc.: collaborator
• University of Oklahoma: lead

Study Sites (1)

University of Oklahoma Health Sciences

Oklahoma City, Oklahoma, 73104, United States

RECRUITING

Related Publications (1)

• 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.

  PMID: 41004800 DERIVED

Study Officials

• Tara C Klinedinst, PhD

  University of Oklahoma Health Sciences

  PRINCIPAL INVESTIGATOR

• Michael C Robertson, PhD, MPH

  University of Oklahoma Health Sciences

  PRINCIPAL INVESTIGATOR

• Zachary C Pope, PhD

  University of Oklahoma Health Sciences

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Zachary C Pope, PhD

CONTACT

208-891-9421; zachary-pope@ouhsc.edu

Tara C Klinedinst, PhD

CONTACT

918-660-3283; tara-klinedinst@ouhsc.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: October 31, 2024
• First Posted: November 4, 2024
• Study Start: November 27, 2024
• Primary Completion (Estimated): May 31, 2026
• Study Completion (Estimated): May 31, 2026
• Last Updated: May 1, 2026

Record last verified: 2026-04

Locations

US (1)