NCT06671730 Self-Determination Theory-informed Occupational Therapy Program to Increase Physical Activity Among Survivors of Breast Cancer
| NCT ID | NCT06671730 |
| Status | Recruiting |
| Phase | — |
| Sponsor | University of Oklahoma |
| Condition | Breast Cancer Survivor |
| Study Type | INTERVENTIONAL |
| Enrollment | 38 participants |
| Start Date | 2024-11-27 |
| Primary Completion | 2026-05-31 |
Eligibility & Interventions
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 38 participants in total. It began in 2024-11-27 with a primary completion date of 2026-05-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Eligibility Criteria
Inclusion Criteria: 1. ≥18 years old. 2. Ability to speak/read English. 3. Ability to provide informed consent. 4. Having ever received a histologically confirmed diagnosis of invasive breast carcinoma. 5. Having undergone breast conserving surgery or mastectomy for BC in the last 12 months. 6. Owning a smartphone and/or computer with internet access. 7. Willing to participate in once-weekly telehealth-delivered OT sessions for eight weeks. Exclusion Criteria: 1. Currently undergoing chemotherapy or radiation as primary cancer treatment. 2. Planning or preparing for surgery as primary treatment or as a reconstruction procedure in the next 3 months. 3. Presence of distant metastasis. 4. 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). 5. 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. 6. Being a prisoner, pregnant, or planning to become pregnant. 7. Currently participating in another PA- or OT-based study, or seeking physical therapy or occupational therapy treatment.
Contact & Investigator
Tara C Klinedinst, PhD
PRINCIPAL INVESTIGATOR
University of Oklahoma Health Sciences
Frequently Asked Questions
Who can join the NCT06671730 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Breast Cancer Survivor. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06671730 currently recruiting?
Yes, NCT06671730 is actively recruiting participants. Contact the research team at zachary-pope@ouhsc.edu for enrollment information.
Where is the NCT06671730 trial being conducted?
This trial is being conducted at Oklahoma City, United States.
Who is sponsoring the NCT06671730 clinical trial?
NCT06671730 is sponsored by University of Oklahoma. The principal investigator is Tara C Klinedinst, PhD at University of Oklahoma Health Sciences. The trial plans to enroll 38 participants.
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