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

Not Applicable

Completed

• Conditions: Breast Cancer
• Interventions: Behavioral: Comprehensive Oncology Rehabilitation and Exercise (CORE) Program

• Registration Number: NCT04594473
• Lead Sponsor: University of Utah

Brief 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.

Detailed 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.

Study Timeline

• Study First Submitted: 2020-10-12
• Study First Submitted QC: 2020-10-19
• Study First Posted: 2020-10-20
• Study Start: 2021-03-24
• Primary Completion: 2023-11-10
• Study Completion: 2023-11-10
• Status Verified: 2024-05
• Last Update Submitted: 2024-05-13
• Last Update Posted: 2024-05-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 72

Inclusion Criteria

• Newly diagnosed stage I-III breast cancer survivors who have plans to undergo breast cancer surgery

Exclusion Criteria

• Stage I-III breast cancer survivors who had received neoadjuvant chemotherapy

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Comprehensive Oncology Rehabilitation and Exercise (CORE) Program	Comprehensive Oncology Rehabilitation and Exercise (CORE) Program	Participants randomized to CORE will be instructed to follow the clinical algorithm for this study. An in-clinic assessment consisting of two questionnaires will be used to identify the appropriate pathway for triage. Participants will be triaged into one of three pathways: Physical Medicine \& Rehabilitation, Personal Optimism With Exercise Recovery, or Exercise Self-Management.

Primary Outcome Measures

Name	Time	Method
Percentage of participants who complete in-clinic assessment	Measured at Post-Diagnosis/Pre-Surgery assessment	Percentage of participants who complete the in-clinic assessment will be used to determine the feasibility of CORE. Clinic staff will ask the participant to complete the PROMIS and Godin surveys for triaging into the CORE algorithm. CORE will be considered feasible if ≥ 66% of participants complete the in-clinic assessment and are assigned to one of the three pathways in the algorithm.
Percentage of participants who complete their referral	Measured at Post-Diagnosis/Pre-Surgery assessment	Percentage of participants who complete their referral to a service pathway will be used to determine the feasibility of CORE. If the participant is triaged into PM\&R or POWER groups based on in-clinic assessment, provider will submit a referral in participant's electronic medical record. Once the referral is submitted, patient navigation staff will be notified and immediately reach out to the participant to schedule with the referred service. CORE will be considered feasible if ≥ 50% of those referred to a service pathway (PM\&R or POWER) complete their referral.

Secondary Outcome Measures

Name	Time	Method
Percentage of themes identified from focus groups that contain positive feedback	Upon completion of 24-weeks post-surgery SOC visit for participants and about one year post-implementation (approximately 1 year into data collection)	To determine the acceptability of CORE, the study team will conduct focus groups one year after implementation of CORE. Four focus groups will be conducted among participants in CORE, and one focus group will be conducted among providers and clinic staff.
Change in exercise engagement assessed via accelerometer	Measured one-week Post-Diagnosis/Pre-Surgery SOC visit, one-week Post-Surgery SOC visit, and one-week 24-Weeks Post-Surgery SOC visit	Researchers will examine the extent to which CORE elicits exercise engagement before and after breast cancer surgery compared to standard of care. At each assessment visit, participants will be provided with an Actigraph GT9X Link tri-axial accelerometer to objectively assess exercise engagement, and will be instructed to wear the device for seven days following their assessment.
Change in exercise engagement assessed via modified Godin survey	Measured one-week Post-Diagnosis/Pre-Surgery SOC visit, one-week Post-Surgery SOC visit, and one-week 24-Weeks Post-Surgery SOC visit	Researchers will examine the extent to which CORE elicits exercise engagement before and after breast cancer surgery compared to standard of care. At each assessment visit, participants will be asked to fill out the modified Godin survey that measures typical weekly frequency of engagement in strenuous, moderate, and mild aerobic exercise. The modified version also inquires about average length of time of aerobic exercise engagement and frequency of resistance exercise.

Trial Locations

Locations (1)

Huntsman Cancer Institute; 🇺🇸 Salt Lake City, Utah, United States