Strength After Breast Cancer (SABC)

Strength After Breast Cancer: Clinical Implementation of an Evidence-based Group Exercise Intervention for Breast Cancer Survivors

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.

Study Overview

• Status: Recruiting
• Conditions: Breast Cancer
• Intervention / Treatment: Behavioral: Strength After Breast Cancer

Detailed 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.

• Study Type: Interventional
• Enrollment (Estimated): 40
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Stephen Wechsler, DPT, PhD; Phone Number: 774-217-3221; Email: swechsler@mghihp.edu
• Study Contact Backup: Name: Kathleen Lyons, ScD, OTR/L; Email: klyons2@mghihp.edu

Study Locations

• United States
  • Massachusetts
    • Boston, Massachusetts, United States, 02129
      • Recruiting
      • MGH Institute of Health Professions
      • Contact: Stephen Wechsler, DPT, PhD; Phone Number: 774-217-3221; Email: swechsler@mghihp.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: Strength After Breast Cancer (SABC) Intervention; 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

Behavioral: Strength After Breast Cancer; Individual physical therapy evaluation and 4 group-based exercise sessions led by a licensed physical therapist

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Screening Rate	Number patients screened / Number patients identified as potentially eligible. Screening rate of at least 75% will indicate feasibility.	At screening
Eligibility Rate	Number patients screening eligible / Number screened. Eligibility rate of at least 75% will indicate feasibility.	At screening
Enrollment Rate	Number participants enrolled / Number screened positive & eligible. A rate of at least 75% will indicate feasibility.	At screening
Assessment completion rate	Number participants completing each of the 4 study assessments / Number of participants enrolled. For this study, an assessment completion rate of 75% will indicate feasibility.	Up to 5 months
Program completion rate	Number participants completing 4 sessions of the SABC intervention / Number of participants enrolled. For this study, the investigators will consider it feasible if 75% of participants complete all 4 sessions.	Up to 2 months
Intervention session completion rate	Number of completed sessions per participant. For this study, the investigators will consider it feasible if the mean number of sessions completed per participant is ≥ 3.	Up to 2 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Participant Satisfaction	Assessed by the post-program satisfaction survey which is a 7-item survey that is rated on a 5-point Likert scale; total score range 7-35 (higher score indicates greater satisfaction). Any item on the Satisfaction survey that generates a mean score of < 4 will trigger consideration of modification to the SABC program.	Up to 2 months
Exercise Self-Efficacy	Assessed with the Self-Efficacy with Exercise scale which consists of nine potential exercise barriers and asks the individual to rate their confidence on a 0 (not confident) - 10 (very confident) scale that they could exercise for twenty minutes, three times per week, given each barrier (total score range 0-90; maximum score of 90 indicates highest exercise self-efficacy).	Up to 5 months
Physical Activity Level	Assessed using the International Physical Activity Questionnaire Long Form to assess duration and frequency of physical activity in the last seven days in domains of: job-related, transportation, housework/house maintenance/caring for family, recreation/sport/leisure-time, and time spent sitting.	Up to 5 months
Quality of Life: Functional Assessment of Cancer Therapy - General	Assessed using the Functional Assessment of Cancer Therapy - General (FACT-G) (28 items), which measures health-related quality of life covering four domains of well-being (physical, social/family, emotional, functional). This measure is included in and will be assessed as part of The Functional Assessment of Chronic Illness Therapy - Fatigue (FACIT-F). Total score range for FACT-G is 0-108 with higher scores indicating greater quality of life.	Up to 5 months
Cancer-Related Fatigue: Functional Assessment of Chronic Illness Treatment - Fatigue, Fatigue subscale	Assessed using the Functional Assessment of Chronic Illness Treatment - Fatigue (FACIT-F), 13 item fatigue subscale. Total score for 13-item fatigue subscale is 0-52 with higher score indicating worse fatigue.	Up to 5 months

Collaborators and Investigators

• Sponsor: MGH Institute of Health Professions
• Investigators: Principal Investigator: Stephen Wechsler, DPT, PhD, MGH Institute of Health Professions

Study record dates

Study Major Dates

• Study Start (Actual): January 2, 2024
• Primary Completion (Estimated): September 1, 2026
• Study Completion (Estimated): March 1, 2027

Study Registration Dates

• First Submitted: September 12, 2023
• First Submitted That Met QC Criteria: September 18, 2023
• First Posted (Actual): September 25, 2023

Study Record Updates

• Last Update Posted (Actual): October 20, 2025
• Last Update Submitted That Met QC Criteria: October 15, 2025
• Last Verified: October 1, 2025

More Information

Terms related to this study

• Keywords: Physical Therapy; Exercise Program
• Additional Relevant MeSH Terms: Neoplasms by Site; Neoplasms; Skin Diseases; Breast Diseases; Skin and Connective Tissue Diseases; Breast Neoplasms
• Other Study ID Numbers: 23-418

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: The Dana-Farber / Harvard Cancer Center encourages and supports the responsible and ethical sharing of data from clinical trials. De-identified participant data from the final research dataset used in the published manuscript may only be shared under the terms of a Data Use Agreement. Requests may be directed to: the Partners Innovations team at http://www.partners.org/innovation. The protocol and statistical analysis plan will be made available on Clinicaltrials.gov only as required by federal regulation or as a condition of awards and agreements supporting the research.
• IPD Sharing Time Frame: Data can be shared no earlier than 1 year following the date of publication
• IPD Sharing Access Criteria: Contact the Partners Innovations team at http://www.partners.org/innovation
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No