Strength After Breast Cancer

NCT06052488 | Recruiting DMC

• 1 other identifier: 23-418
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Breast Cancer

Keywords

Physical Therapy; Exercise Program

Outcome Measures

Primary Outcomes (6)

• 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

• 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

• 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

Secondary Outcomes (5)

• Participant Satisfaction

  Up to 2 months

• Exercise Self-Efficacy

  Up to 5 months

• Physical Activity Level

  Up to 5 months

• Quality of Life: Functional Assessment of Cancer Therapy - General

  Up to 5 months

• Cancer-Related Fatigue: Functional Assessment of Chronic Illness Treatment - Fatigue, Fatigue subscale

  Up to 5 months

Study Arms (1)

Strength After Breast Cancer (SABC) Intervention

EXPERIMENTAL

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

Interventions

Strength After Breast Cancer BEHAVIORAL

Individual physical therapy evaluation and 4 group-based exercise sessions led by a licensed physical therapist

Strength After Breast Cancer (SABC) Intervention

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: These eligibility criteria are aligned with the criteria outlined by the developers of the Strength After Breast Cancer program. This program was developed for women after treatment for breast cancer.
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• ≥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

You may not qualify if:

• 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

Sponsors & Collaborators

• MGH Institute of Health Professions: lead

Study Sites (1)

MGH Institute of Health Professions

Boston, Massachusetts, 02129, United States

RECRUITING

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Stephen Wechsler, DPT, PhD

  MGH Institute of Health Professions

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Stephen Wechsler, DPT, PhD

CONTACT

774-217-3221; swechsler@mghihp.edu

Kathleen Lyons, ScD, OTR/L

CONTACT

klyons2@mghihp.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: September 12, 2023
• First Posted: September 25, 2023
• Study Start: January 2, 2024
• Primary Completion (Estimated): September 1, 2026
• Study Completion (Estimated): March 1, 2027
• Last Updated: October 20, 2025

Record last verified: 2025-10

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: Data can be shared no earlier than 1 year following the date of publication
• Access Criteria: Contact the Partners Innovations team at http://www.partners.org/innovation

Locations

US (1)