Strength After Breast Cancer (SABC)

MGH Institute of Health Professions

Status: Enrolling

Conditions: Breast Cancer

Treatments: Behavioral: Strength After Breast Cancer

Study type: Interventional

Funder types: Other

Identifiers

NCT06052488

23-418

Details and patient eligibility

About

The goal of this study is to explore whether a group exercise program called Strength After Breast Cancer can be delivered in an outpatient physical therapy clinic to improve physical function among women after treatment for breast cancer.

The main questions this study aims to answer are:

• Can the Strength After Breast Cancer program and the associated outcome battery be successfully delivered in an outpatient physical therapy clinic at Massachusetts General Hospital and do participants find the program practical?
• What are the barriers to and facilitators of delivering the group exercise program in a clinical setting and what changes need to be made to the program to improve sustainability and to facilitate implementation at other clinical sites?

Participants will complete study questionnaires before and after engaging in the group exercise program and they will participate in interviews following participation in the program.

Full description

The goal of this single arm feasibility study of the Strength After Breast Cancer (SABC) evidence-based group exercise intervention for women after treatment for breast cancer is to determine if investigators can feasibly deliver the program out of the outpatient physical therapy clinic at Massachusetts General Hospital Waltham.

- Following a one-on-one physical therapy evaluation, the four-session SABC program provides a group-based but individualized exercise plan and encourages engagement in independent home-based exercises to improve physical function. The SABC program has previously been found to be safe and led to improvements in physical function among women after treatment for breast cancer. Therefore, the focus of this study is to explore clinical implementation barriers, facilitators, and necessary program adaptations to enhance sustainability and facilitate implementation at other clinical sites.

Study procedures include screening for eligibility, in-clinic visits, questionnaires, and a semi-structured interview.

Participation in this research study is expected to last up to 5 months. It is expected that up to 40 people will take part in this research study.

This is an unfunded study.

Enrollment: 40 estimated patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• ≥18 years of age
• Diagnosed with Stage I-III breast cancer, having completed primary cancer treatment (e.g., surgery, chemotherapy, radiation therapy); hormonal therapies and adjuvant targeted therapies will be permitted

Exclusion criteria

• Any injury or medical condition that would prohibit being able to safely perform exercise as indicated by the Physical Activity Readiness Questionnaire (i.e., atrial fibrillation, chest pain or angina, uncontrolled high blood pressure or hypertension, loss of balance due to dizziness in the past 12 months, or loss of consciousness in the past 12 months).
• Non-English speaking

Trial design

Primary purpose: Health Services Research

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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40 participants in 1 patient group

Strength After Breast Cancer (SABC) Intervention

Experimental group

Description:

Participants will undergo study procedures as outlined: * Complete a baseline survey regarding exercise self-efficacy, physical activity level, quality of life, and fatigue * Attend a 1-on-1 physical therapy evaluation and 4 group exercise sessions at MGH Waltham * After completing the 4 exercise sessions, complete follow-up surveys including a program satisfaction survey * At 1-month post-program, complete follow-up surveys and an individual, semi-structured interview with study staff to supply feedback about the program. * At 3-months post-program, complete follow-up surveys

Treatment:

Behavioral: Strength After Breast Cancer