Clinical trial NCT06052488: Strength After Breast Cancer
Official title: Strength After Breast Cancer: Clinical Implementation of an Evidence-based Group Exercise Intervention for Breast Cancer Survivors
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Breast Cancer
Keywords: Physical Therapy
Exercise Program
Lead sponsor: MGH Institute of Health Professions
Sponsor class: OTHER
First posted: 2023-09-25
Enrollment: 40
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: HEALTH_SERVICES_RESEARCH

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.

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.

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

Primary outcomes:
measure: Screening Rate
timeFrame: At screening
measure: Eligibility Rate
timeFrame: At screening
measure: Enrollment Rate
timeFrame: At screening
measure: Program completion rate
timeFrame: Up to 2 months
measure: Intervention session completion rate
timeFrame: Up to 2 months
measure: Assessment completion rate
timeFrame: Up to 5 months
Secondary outcomes:
measure: Participant Satisfaction
timeFrame: Up to 2 months
measure: Exercise Self-Efficacy
timeFrame: Up to 5 months
measure: Physical Activity Level
timeFrame: Up to 5 months
measure: Quality of Life: Functional Assessment of Cancer Therapy - General
timeFrame: Up to 5 months
measure: Cancer-Related Fatigue: Functional Assessment of Chronic Illness Treatment - Fatigue, Fatigue subscale
timeFrame: Up to 5 months
Other outcomes:
Locations:
city: Boston
country: United States
facility: MGH Institute of Health Professions
state: Massachusetts
Study officials:
affiliation: MGH Institute of Health Professions
name: Stephen Wechsler, DPT, PhD
role: PRINCIPAL_INVESTIGATOR
References: