This clinical trial evaluates a behavioral intervention (Moving on-After Breast Cancer [MOve-ABC]) for improving physical and functional quality of life in patients starting treatment for breast cancer. Patients receiving treatment for breast cancer can experience a number of physical and functional side effects that reduce their quality of life and/or make it difficult to perform daily activities. Physical therapy is a rehabilitative discipline that uses exercise and education to improve movement, strength, balance, and function and to reduce pain. Physical therapy delivered before the start of cancer treatment may improve a patient's response to treatment and reduce the number or intensity of side effects they experience. The MOve-ABC intervention includes a physical therapy evaluation with education and an exercise plan prior to starting treatment, followed by additional education, regular symptom monitoring assessments, and reinforcement check-ins after starting therapy. The MOve-ABC intervention may improve physical and functional quality of life in patients starting breast cancer treatment by preventing or mitigating side effects, and preparing patients and their providers for early detection and management of side effects as they occur.
Study sponsor and potential other locations can be found on ClinicalTrials.gov for NCT06081127.
PRIMARY OBJECTIVE:
I. To determine the feasibility (acceptability and suitability) and potential effects of MOve-ABC on physical and functional side effects (PFs) relative to enhanced usual care in a large academic medical system.
SECONDARY OBJECTIVE:
I. Determine whether MOve-ABC also affects patient self-management and provider knowledge and behaviors related to detection and management of PF effects.
EXPLORATORY OBJECTIVES:
I. Upper extremity fluid volume and body composition (lean versus [v.] fat mass) will be measured with bioimpedance.
II. Two surveys will be used to objectively measure general activity, mood, ability to walk, normal work, relations with others, sleep, and enjoyment in life.
III. The European Organization for Research and Treatment of Cancer Quality of Life Questionnaire 25-item Information Module (EORTC-QLQ-INFO25) Overall Information Satisfaction Survey will be used to measure the amount of information received by patients about their disease, and their satisfaction with that level of information.
IV. Three computerized patient reported outcome (CPRO) 2-item forms will be used: the CPRO pain, fatigue, and physical function surveys.
V. Will control for comorbidity with the Charlson Comorbidity Index age, date of breast cancer (BC) diagnosis, years of formal education, race and ethnicity, insurance type.
OUTLINE: Patients are randomized to 1 of 2 arms.
ARM I: Patients receive enhanced usual care (EUC) which consists of their planned oncology treatment, education by their oncology team, laboratory and/or radiological testing as needed, and monthly symptom monitoring assessments for 6 months.
ARM II: Patients receive EUC as in Arm I for 6 months. In addition to usual care, patients also receive the MOve-ABC intervention, in which they attend a physical therapy evaluation, receive education on self-management and recovery expectations, and receive an individualized home exercise prescription plan on day 1, 2 weeks prior to beginning cancer treatment. Patients receive access to an educational website about treatment side effects, post-operative precautions, and recovery expectations and also receive regular reinforcement check-ins for 6 months (daily text messages and weekly phone calls in month 1, weekly phone calls and text messages in months 2 and 3, and monthly phone calls in months 4-6). Patients are also notified of the results of their monthly symptom monitoring surveys and may receive education on the benefits of physical therapy as well as a list of physical therapy resources near the patient's home.
Trial PhaseNo phase specified
Trial Typesupportive care
Lead OrganizationNorthwestern University
Principal InvestigatorAnn Marie Flores
