Strength After Breast Cancer
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Strength After Breast Cancer.
- Who it may be relevant to
- Registry conditions: Breast Cancer. Basic parameters: from 18 years · Female.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Strength After Breast Cancer: Clinical Implementation of an Evidence-based Group Exercise Intervention for Breast Cancer Survivors
Overview
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.
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.
Interventions
- Behavioral Strength After Breast Cancer
Individual physical therapy evaluation and 4 group-based exercise sessions led by a licensed physical therapist
Primary outcome measures
- Screening Rate [Time frame: At screening]
- Eligibility Rate [Time frame: At screening]
- Enrollment Rate [Time frame: At screening]
- Program completion rate [Time frame: Up to 2 months]
- Intervention session completion rate [Time frame: Up to 2 months]
- Assessment completion rate [Time frame: Up to 5 months]
Secondary outcome measures (5)
- Participant Satisfaction [Time frame: Up to 2 months]
- Exercise Self-Efficacy [Time frame: Up to 5 months]
- Physical Activity Level [Time frame: Up to 5 months]
- Quality of Life: Functional Assessment of Cancer Therapy - General [Time frame: Up to 5 months]
- Cancer-Related Fatigue: Functional Assessment of Chronic Illness Treatment - Fatigue, Fatigue subscale [Time frame: Up to 5 months]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Health services research
Study locations
United States · 1 center
- MGH Institute of Health Professions — Boston
Identifiers
NCT: NCT06052488 · 23-418