Telehealth Occupational Therapy Program for Breast Cancer Survivors

Digitally Mediated Occupational Therapy Program to Increase Physical Activity in Urban and Rural Breast Cancer Survivors Who Have Undergone Breast-conserving Surgery or Mastectomy

This study tests a new online occupational therapy program to help breast cancer survivors get more active and strengthen their muscles to improve their health and quality of life.

Quick facts

• Phase: NA
• Study type: Interventional
• Enrollment: 38 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: University of Oklahoma (other)
• Drugs / interventions: chemotherapy, radiation
• Locations: 1 site (Oklahoma City, Oklahoma)
• Trial ID: NCT06671730 on ClinicalTrials.gov

What this trial studies

This program evaluates an 8-week telehealth-delivered occupational therapy initiative aimed at increasing physical activity and muscle strengthening among breast cancer survivors. By focusing on individual preferences for aerobic physical activity and muscle strengthening exercises, the program seeks to enhance long-term engagement in these health-promoting behaviors. The telehealth format addresses barriers to access, particularly for those living in rural areas, and aims to improve physical functioning and overall quality of life for participants. The program is designed for those who have undergone breast-conserving surgery or mastectomy within the last year.

Who should consider this trial

Good fit: Ideal candidates are breast cancer survivors aged 18 and older who have undergone surgery within the last 12 months and have access to the necessary technology for telehealth sessions.

Not a fit: Patients currently undergoing chemotherapy or radiation, or those with distant metastasis, may not benefit from this program.

Why it matters

Potential benefit: If successful, this program could significantly improve the physical and mental health-related quality of life for breast cancer survivors.

How similar studies have performed: Other studies have shown positive outcomes with telehealth interventions for cancer survivors, indicating potential success for this approach.

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.

Where this trial is running

Oklahoma City, Oklahoma

• University of Oklahoma Health Sciences — Oklahoma City, Oklahoma, United States (RECRUITING)

Study contacts

• Principal investigator: Tara C Klinedinst, PhD — University of Oklahoma Health Sciences
• Study coordinator: Zachary C Pope, PhD

Conditions: Breast Cancer Survivor, Aerobic Physical Activity, Muscle Strengthening Exercise, Patient Reported Outcomes, Feasibility, Acceptability, Wearable Devices, Telehealth