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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

41 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-05-11

Study Completion Date

2024-10-04

Brief Summary

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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).

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Detailed Description

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Conditions

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Breast Cancer Cancer of the Breast

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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Physical Activity Intervention

* 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.

Group Type EXPERIMENTAL

Physical Activity Intervention

Intervention Type OTHER

Fitbit wearable device, home exercise sessions, and telehealth appointments with physical therapist.

Usual care, wait-list control condition

-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.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Physical Activity Intervention

Fitbit wearable device, home exercise sessions, and telehealth appointments with physical therapist.

Intervention Type OTHER

Eligibility Criteria

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Inclusion 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.

Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No