Clinical trial NCT04594473: A Comprehensive Oncology Rehabilitation and Exercise (CORE) Program Among Breast Cancer Survivors
Official title: The Feasibility and Acceptability of a Comprehensive Oncology Rehabilitation and Exercise (CORE) Program Among Breast Cancer Survivors
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Breast Cancer
Keywords: Survivors
Exercise
Lead sponsor: University of Utah
Sponsor class: OTHER
First posted: 2020-10-20
Enrollment: 72
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

Eligibility criteria: 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

Primary outcomes:
measure: Percentage of participants who complete in-clinic assessment
timeFrame: Measured at Post-Diagnosis/Pre-Surgery assessment
measure: Percentage of participants who complete their referral
timeFrame: Measured at Post-Diagnosis/Pre-Surgery assessment
Secondary outcomes:
measure: Percentage of themes identified from focus groups that contain positive feedback
timeFrame: Upon completion of 24-weeks post-surgery SOC visit for participants and about one year post-implementation (approximately 1 year into data collection)
measure: Change in exercise engagement assessed via accelerometer
timeFrame: Measured one-week Post-Diagnosis/Pre-Surgery SOC visit, one-week Post-Surgery SOC visit, and one-week 24-Weeks Post-Surgery SOC visit
measure: Change in exercise engagement assessed via modified Godin survey
timeFrame: Measured one-week Post-Diagnosis/Pre-Surgery SOC visit, one-week Post-Surgery SOC visit, and one-week 24-Weeks Post-Surgery SOC visit
Other outcomes:
Locations:
city: Salt Lake City
country: United States
facility: Huntsman Cancer Institute
state: Utah
Study officials:
References:
citation: U.S. Department of Health and Human Services. Physical Activity Guidelines for Americans, 2nd edition. Washing, DC: US. Department of Health and Human Services; 2018.
citation: Rothrock NE, Cook KF, O'Connor M, Cella D, Smith AW, Yount SE. Establishing clinically-relevant terms and severity thresholds for Patient-Reported Outcomes Measurement Information System(R) (PROMIS(R)) measures of physical function, cognitive function, and sleep disturbance in people with cancer using standard setting. Qual Life Res. 2019 Dec;28(12):3355-3362. doi: 10.1007/s11136-019-02261-2. Epub 2019 Aug 13.