Prehabilitation to Revolutionize Oncology: Telehealth Exercise for Cognitive Triumphs (The PROTECT Trial)

The Washington University

Status: Completed

Conditions: Breast Cancer; Cancer of the Breast

Treatments: Other: Physical Activity Intervention

Study type: Interventional

Funder types: Other

Identifiers

NCT05716542

202302077

Details and patient eligibility

About

The investigators propose to deliver a pilot randomized controlled trial to 40 women newly diagnosed with breast cancer and scheduled to undergo chemotherapy. The current objectives are: 1) to evaluate the preliminary efficacy of the prehabilitation physical activity (PA) intervention delivered by a physical therapist and 2) assess the intervention's feasibility, acceptability, and appropriateness. The long-term goal is to scale this intervention for implementation into the standard of cancer care to prevent, mitigate, and treat cancer-related cognitive decline (CRCD).

Enrollment: 41 patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Eligibility Criteria:

• Diagnosis of breast cancer (stage I-III).
• Female.
• At least 18 years old.
• Scheduled to receive curative-intent chemotherapy.
• English speaking.
• Deemed fit to participate in a PA intervention by their oncologist.
• Not currently participating in another physical activity research study.
• Low active, defined by self-report as no more than 2 times per week of regular physical activity in the last six months
• Able to understand and willing to sign an IRB-approved written informed consent document.

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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41 participants in 2 patient groups

Physical Activity Intervention

Experimental group

Description:

* Participants will complete a primarily home-based PA intervention, with the goal of safely increasing their steps/day by incorporating moderate-to-vigorous physical activity (MVPA) * Participants will receive Fitbits with heart rate capabilities to support maintenance of the prescribed intensity during home exercise sessions and participants' self-monitoring of daily steps. * Participants will strategize aerobic MVPA behaviors with the intervention PT to identify preferable and enjoyable PA modalities (e.g., walking, cycling), while also identifying alternative options to allow for flexibility if life- or cancer-specific barriers arise * During the first Zoom coaching session, the intervention PT will train participants on using the Fitbit and completing home exercise logs. The PT will continue to meet with participants to support exercise maintenance, review home exercise sessions, strategize new exercises, and troubleshoot emerging chemotherapy-related health declines.

Treatment:

Other: Physical Activity Intervention

Usual care, wait-list control condition

No Intervention group

Description:

-Participants in the control group will proceed with their treatment regimen as prescribed by their oncologist(s). To prevent drop out and high attrition rates as well as promote healthy behavior, control group participants will receive a Fitbit at the initial set-up meeting to wear during chemotherapy, as well as an individualized home exercise program and up to two Zoom coaching sessions with a PT after chemotherapy completion.