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Exercise Program for Breast Cancer Cognitive Health

N/A

Recruiting

Led By Elizabeth A Salerno, Ph.D., MPH

Research Sponsored by Washington University School of Medicine

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Diagnosis of breast cancer (stage I-III)

At least 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up after completion of intervention (estimated to be 12 weeks)

Awards & highlights

Study Summary

This trial will evaluate a physical activity intervention to prevent cognitive decline in women newly diagnosed with breast cancer before chemotherapy.

Who is the study for?

This trial is for women over 18 with early-stage breast cancer (stage I-III) who are not very active, speak English, and are about to start chemotherapy. They must be able to consent and be cleared by their oncologist for physical activity. Women already in a PA study can't join.Check my eligibility

What is being tested?

The PROTECT Trial is testing a prehabilitation exercise program delivered via telehealth by physical therapists to see if it's effective and practical before starting chemo, aiming to prevent or lessen cognitive decline related to cancer treatment.See study design

What are the potential side effects?

Since this intervention involves physical activity prescribed by therapists, potential side effects may include muscle soreness, fatigue, or injury. However, the risk is low as participants will be assessed as fit for exercise by their oncologists.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I have been diagnosed with stage I-III breast cancer.

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I am 18 years old or older.

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I am scheduled for chemotherapy aimed at curing my cancer.

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I am female.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ after completion of intervention (estimated to be 12 weeks)

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~after completion of intervention (estimated to be 12 weeks)

This trial's timeline: 3 weeks for screening, Varies for treatment, and after completion of intervention (estimated to be 12 weeks) for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

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

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

Secondary outcome measures

Acceptability of the intervention as measured by the Acceptability of Intervention Measure (AIM)

Adherence of the intervention as measured by percentage of home exercise sessions and PT telehealth appointments completed

Appropriateness of the intervention as measured by the Intervention Appropriateness Measure (IAM)

+7 more

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Physical Activity InterventionExperimental Treatment1 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 II: Usual care, wait-list control conditionActive Control1 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.

0 / 4Eligibility criteria met

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Who is running the clinical trial?

Washington University School of MedicineLead Sponsor

1,937 Previous Clinical Trials

2,299,655 Total Patients Enrolled

46 Trials studying Breast Cancer

5,128 Patients Enrolled for Breast Cancer

The Foundation for Barnes-Jewish HospitalOTHER

37 Previous Clinical Trials

6,741 Total Patients Enrolled

6 Trials studying Breast Cancer

622 Patients Enrolled for Breast Cancer

Elizabeth A Salerno, Ph.D., MPHPrincipal InvestigatorWashington University School of Medicine

Media Library

Physical Activity Intervention Clinical Trial Eligibility Overview. Trial Name: NCT05716542 — N/A

Breast Cancer Research Study Groups: Physical Activity Intervention, Usual care, wait-list control condition

Breast Cancer Clinical Trial 2023: Physical Activity Intervention Highlights & Side Effects. Trial Name: NCT05716542 — N/A

Physical Activity Intervention 2023 Treatment Timeline for Medical Study. Trial Name: NCT05716542 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there any remaining opportunities to participate in this clinical trial?

"Per the information on clinicaltrials.gov, this particular trial is no longer actively enrolling patients; it was first posted on February 28th 2023 and last edited January 27th 2023. Despite that fact, there are 2,543 other trials in search of candidates at present time."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

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

2023. "Prehabilitation to Revolutionize Oncology: Telehealth Exercise for Cognitive Triumphs (The PROTECT Trial)". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05716542.

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