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

NCT05716542 | Completed

• 1 other identifier: 202302077
• Study Type: interventional
• Target: 41
• Locations: 1 country
• Sites: 1

Brief Summary

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).

Conditions

Breast Cancer; Cancer of the Breast

Keywords

prehabilitation; physical activity; cancer-related cognitive decline; telehealth; physical therapy; survivorship; breast cancer

Outcome Measures

Primary Outcomes (2)

• Changes in self-reported cognition function as measured by FACT-Cog

  The FACT-Cog examines a range of self-reported cognitive domains, including perceived cognitive impairment (PCI, range 0-71), perceived cognitive abilities (PCA, range 0-28), impact of cognitive impairment on quality of life (CogQOL, range 0-16), cognitive impairment perceived by others (CogOth, range 0-16), and a total cognitive functioning score (the sum of the other 4 subscales). Higher scores indicate fewer cognitive difficulties.

  Pre-chemotherapy and post-chemotherapy (estimated to be 12 weeks)

• Feasibility of the intervention as measured by Feasibility of Intervention Measure (FIM)

  The FIM measures the degree to which a participant feels an intervention is feasible to them. It ranges from 4-20, and higher scores indicate more feasibility. We will use a cutoff of 16 to indicate "feasible"

  After completion of intervention (estimated to be 12 weeks)

Secondary Outcomes (10)

• Changes in objective measures of cognition function as measured by BrainBaseline Spatial Working Memory

  Pre-chemotherapy and post-chemotherapy (estimated to be 12 weeks)

• Changes in objective measures of cognition function as measured by BrainBaseline N-back

  Pre-chemotherapy and post-chemotherapy (estimated to be 12 weeks)

• Changes in objective measures of cognition function as measured by BrainBaseline Flanker

  Pre-chemotherapy and post-chemotherapy (estimated to be 12 weeks)

• Changes in objective measures of cognition function as measured by BrainBaseline Trails A&B

  Pre-chemotherapy and post-chemotherapy (estimated to be 12 weeks)

• Changes in objective measures of cognition function as measured by BrainBaseline Stroop

  Pre-chemotherapy and post-chemotherapy (estimated to be 12 weeks)

Study Arms (2)

Physical Activity Intervention

EXPERIMENTAL

* 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.

Other: Physical Activity Intervention

Usual care, wait-list control condition

NO INTERVENTION

-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.

Interventions

Physical Activity Intervention OTHER

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

Physical Activity Intervention

Eligibility Criteria

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

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.

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• Washington University School of Medicine: lead
• The Foundation for Barnes-Jewish Hospital: collaborator

Study Sites (1)

Washington University School of Medicine

St Louis, Missouri, 63110, United States

Location

Related Links

• Alvin J. Siteman Cancer Center at Barnes-Jewish Hospital and Washington University School of Medicine

MeSH Terms

Conditions

Breast Neoplasms; Motor Activity

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Behavior

Study Officials

• Lindsay Peterson, M.D., MSCR

  Washington University School of Medicine

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: January 17, 2023
• First Posted: February 8, 2023
• Study Start: May 11, 2023
• Primary Completion: October 4, 2024
• Study Completion: October 4, 2024
• Last Updated: August 28, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)