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

May 15, 2023 updated by: Washington University School of Medicine
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).

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

40

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • United States
    • Missouri
      • Saint Louis, Missouri, United States, 63110
        • Recruiting
        • Washington University School of Medicine
        • Contact:
        • Principal Investigator:
          • Elizabeth A Salerno, Ph.D., MPH
        • Sub-Investigator:
          • Lindsay Peterson, M.D., MSCR
        • Sub-Investigator:
          • Ryan Duncan, PT, DPT, MSCI
        • Sub-Investigator:
          • Maura Kepper, Ph.D.
        • Sub-Investigator:
          • Jingqin Luo, Ph.D.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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.
Other: Physical Activity Intervention
Fitbit wearable device, home exercise sessions, and telehealth appointments with physical therapist.
No Intervention: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Changes in self-reported cognition function as measured by FACT-Cog
Time Frame: Pre-chemotherapy and post-chemotherapy (estimated to be 12 weeks)
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)
Time Frame: After completion of intervention (estimated to be 12 weeks)
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Changes in objective measures of cognition function as measured by BrainBaseline Spatial Working Memory
Time Frame: Pre-chemotherapy and post-chemotherapy (estimated to be 12 weeks)
BrainBaseline is a tool that delivers a battery of objective cognitive tests. The investigators will measure the participant's ability to hold information about an object's location in short term memory. Overall accuracy is the primary measure of performance. Accuracy ranges from 0-100%. Higher accuracy scores represent better accuracy.
Pre-chemotherapy and post-chemotherapy (estimated to be 12 weeks)
Changes in objective measures of cognition function as measured by BrainBaseline N-back
Time Frame: Pre-chemotherapy and post-chemotherapy (estimated to be 12 weeks)

BrainBaseline is a tool that delivers a battery of objective cognitive tests. The investigators will assess the participant's ability to retain sequentially presented information in short-term memory. Overall accuracy is considered the primary measure of performance.

Accuracy ranges from 0-100%. Higher accuracy scores represent better accuracy.
Pre-chemotherapy and post-chemotherapy (estimated to be 12 weeks)
Changes in objective measures of cognition function as measured by BrainBaseline Flanker
Time Frame: Pre-chemotherapy and post-chemotherapy (estimated to be 12 weeks)
BrainBaseline is a tool that delivers a battery of objective cognitive tests. The investigators will assess the participant's ability to focus attention and block irrelevant information. Task performance is assessed by observing reaction time cost. Reaction time ranges from 0-5000 milliseconds. Higher reaction times represent slower reaction time.
Pre-chemotherapy and post-chemotherapy (estimated to be 12 weeks)
Changes in objective measures of cognition function as measured by BrainBaseline Trails A&B
Time Frame: Pre-chemotherapy and post-chemotherapy (estimated to be 12 weeks)
BrainBaseline is a tool that delivers a battery of objective cognitive tests. The investigators will assess the participant's ability to connect-the-dots, drawing a line between targets in a specified ascending order. Task performance is assessed by observing time to completion. A higher time to completion represents a slower ability to connect-the-dots.
Pre-chemotherapy and post-chemotherapy (estimated to be 12 weeks)
Changes in objective measures of cognition function as measured by BrainBaseline Stroop
Time Frame: Pre-chemotherapy and post-chemotherapy (estimated to be 12 weeks)
BrainBaseline is a tool that delivers a battery of objective cognitive tests. The investigators will measure the participant's ability to focus attention on a particular stimulus dimension while ignoring another. Task performance is assessed by observing the reaction time cost. Reaction time ranges from 0-5000 milliseconds. Higher reaction time scores represent slower reaction time.
Pre-chemotherapy and post-chemotherapy (estimated to be 12 weeks)
Changes in objective measures of cognition function as measured by BrainBaseline Task switching
Time Frame: Pre-chemotherapy and post-chemotherapy (estimated to be 12 weeks)
BrainBaseline is a tool that delivers a battery of objective cognitive tests. The investigators will measure the participant's ability to switch between two separate tasks. The primary outcome measure is switch cost. Reaction time ranges from 0-5000 milliseconds. Higher reaction time scores represent slower reaction time.
Pre-chemotherapy and post-chemotherapy (estimated to be 12 weeks)
Changes in objective measures of cognition function as measured by BrainBaseline Digit Symbol Substitution
Time Frame: Pre-chemotherapy and post-chemotherapy (estimated to be 12 weeks)
BrainBaseline is a tool that delivers a battery of objective cognitive tests. The investigators will measure the participant's ability to quickly and precisely shift attention from location to another, as well as measuring motor skill. The primary outcome measure is the number of correct substitutions made within the 90-second limit.
Pre-chemotherapy and post-chemotherapy (estimated to be 12 weeks)
Acceptability of the intervention as measured by the Acceptability of Intervention Measure (AIM)
Time Frame: After completion of intervention (estimated to be 12 weeks)
The AIM measures the degree to which a participant feels an intervention is acceptable to them. It ranges from 4-20, and higher scores indicate more acceptability. The investigators will use a cutoff of 16 to indicate "acceptable"
After completion of intervention (estimated to be 12 weeks)
Appropriateness of the intervention as measured by the Intervention Appropriateness Measure (IAM)
Time Frame: After completion of intervention (estimated to be 12 weeks)
The IAM measures the degree to which a participant feels an intervention is appropriate for them. It ranges from 4-20, and higher scores indicate more appropriateness. The investigators will use a cutoff of 16 to indicate "appropriate"
After completion of intervention (estimated to be 12 weeks)
Adherence of the intervention as measured by percentage of home exercise sessions and PT telehealth appointments completed
Time Frame: After completion of intervention (estimated to be 12 weeks)
After completion of intervention (estimated to be 12 weeks)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Washington University School of Medicine

Collaborators

The Foundation for Barnes-Jewish Hospital

Investigators

  • Principal Investigator: Elizabeth A Salerno, Ph.D., MPH, Washington University School of Medicine

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 11, 2023

Primary Completion (Anticipated)

November 30, 2024

Study Completion (Anticipated)

November 30, 2024

Study Registration Dates

First Submitted

January 17, 2023

First Submitted That Met QC Criteria

January 27, 2023

First Posted (Actual)

February 8, 2023

Study Record Updates

Last Update Posted (Actual)

May 17, 2023

Last Update Submitted That Met QC Criteria

May 15, 2023

Last Verified

May 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 202302077

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Breast Cancer

Clinical Trials on Physical Activity Intervention

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in South Korea

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe