This clinical trial studies the feasibility and acceptability of a Comprehensive Oncology Rehabilitation and Exercise (CORE) program among breast cancer patients. This CORE program aims to integrate exercise and rehabilitation services as part of standard of care for all cancer survivors, from the time of cancer diagnosis and beyond.
Additional locations may be listed on ClinicalTrials.gov for NCT04594473.
See trial information on ClinicalTrials.gov for a list of participating sites.
PRIMARY OBJECTIVE:
I. Determine the feasibility of the clinical algorithm utilized in Comprehensive Oncology Rehabilitation and Exercise (CORE) to triage survivors to exercise and rehabilitation services.
SECONDARY OBJECTIVES:
I. Assess the acceptability of CORE among survivors, providers and clinic staff.
II. Generate preliminary estimates of the extent to which CORE elicits exercise engagement before and after breast cancer surgery compared with standard of care (SOC).
III. Generate preliminary estimates of the extent to which CORE impacts change in physical function and quality of life (QoL) compared with standard of care.
OUTLINE: Patients are randomized to 1 of 2 arms.
ARM I (STANDARD OF CARE): Patients continue their normal lifestyle activity.
ARM II (CORE PROGRAM): Based upon the results of physical function and physical activity questionnaires, patients participate in either physical medicine and rehabilitation service, personal optimism with exercise recovery program, or exercise-self management program for up to 24 weeks.
Trial PhaseNo phase specified
Trial Typesupportive care
Lead OrganizationHuntsman Cancer Institute/University of Utah
Principal InvestigatorAdriana Coletta
