Strength After Breast Cancer

Breast Cancer Clinical Trial

— SABC  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06052488
• Other study ID #: 23-418
• Status: Recruiting
• Phase: N/A
• Start date: January 2, 2024
• Est. completion date: March 2025

Study information

• Verified date: February 2024
• Source: MGH Institute of Health Professions
• Contact: Stephen Wechsler, DPT, PhD
• Phone: 774-217-3221
• Email: swechsler[@]mghihp.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 40
• Est. completion date: March 2025
• Est. primary completion date: September 2024
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms

Intervention

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

Locations

Country	Name	City	State
United States	MGH Institute of Health Professions	Boston	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
MGH Institute of Health Professions

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Screening Rate	Number patients screened / Number patients identified as potentially eligible. Screening rate of at least 75% will indicate feasibility.	At screening
Primary	Eligibility Rate	Number patients screening eligible / Number screened. Eligibility rate of at least 75% will indicate feasibility.	At screening
Primary	Enrollment Rate	Number participants enrolled / Number screened positive & eligible. A rate of at least 75% will indicate feasibility.	At screening
Primary	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
Primary	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
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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