A Comprehensive Oncology Rehabilitation and Exercise (CORE) Program Among Breast Cancer Survivors — CORE  

Breast Cancer Clinical Trial

Official title: The Feasibility and Acceptability of a Comprehensive Oncology Rehabilitation and Exercise (CORE) Program Among Breast Cancer Survivors

Status Completed

Clinical Trial Summary

The objective of this study is to demonstrate the feasibility and acceptability of the algorithm utilized within a cancer rehab program, named Comprehensive Oncology Rehabilitation and Exercise (CORE) program, among newly diagnosed stage I-III breast cancer survivors, providers, and clinic staff. Additionally, this study aims to generate preliminary estimates on the extent to which CORE, compared with standard of care (SOC), elicits engagement in exercise and impacts changes in physical function and quality of life within this population.

Clinical Trial Description

Enrollment: The study team will recruit 72 newly diagnosed stage I-III breast cancer survivors to participate in a 24-week randomized controlled trial. Participants will be randomized to CORE or SOC in a 2:1 ratio, stratified by adherence to national physical activity guidelines.

Exercise Intervention: Participants randomized to standard of care will be instructed to continue their typical lifestyle activity. Participants randomized to CORE will complete an in-clinic assessment consisting of the PROMIS Physical Function and Godin surveys to identify the appropriate pathway for triage. Results from the questionnaires will be used to triage participants into one of three groups:

1. Physical Medicine & Rehabilitation (PM&R): This rehab service is aimed at improving complex and acute functional deficits. Participants with a T-score < 40 on PROMIS will be triaged to PM&R, regardless of current exercise engagement.

2. Personal Optimism With Exercise Recovery (POWER): POWER is our institution's exercise oncology program. POWER is aimed at improving mild functional deficits and physical deconditioning. Participants with a T-score of 40-50 on PROMIS who are not meeting activity guidelines, will be triaged to POWER. Participants with a T-score of ≥ 40 who are meeting activity guidelines, may choose to participate in POWER or be re-triaged to Exercise Self-Management.

3. Exercise Self-Management: This arm is aimed for participants who are fit and free of functional deficits and impaired physical conditioning. Participants with a T-score of ≥ 51 on PROMIS and currently meeting activity guidelines will be triaged to this group. They may choose to participate in POWER.

Assessments: Five assessment methods will be collected over three time points: (1) Post-Diagnosis/Pre-Surgery, (2) Post-Surgery, and (3) 24-weeks Post-Surgery. ;

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms

• NCT number: NCT04594473
• Study type: Interventional
• Source: University of Utah
• Status: Completed
• Phase: N/A
• Start date: March 24, 2021
• Completion date: November 10, 2023