Strength After Breast Cancer
ConditionBreast Cancer
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age18+
SponsorMGH Institute of Health Professions
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
≥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
Disqualifiers
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
Trial design
Design model
Single group
Treatments tested in this trial
Strength After Breast Cancer
BehavioralIndividual physical therapy evaluation and 4 group-based exercise sessions led by a licensed physical therapist
Treatment groups
40 Participants
are divided into 1 treatment groupGroup A: Strength After Breast Cancer (SABC) InterventionExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Screening Rate
Number patients screened / Number patients identified as potentially eligible. Screening rate of at least 75% will indicate feasibility.
Time frame
At screening2
Eligibility Rate
Number patients screening eligible / Number screened. Eligibility rate of at least 75% will indicate feasibility.
Time frame
At screening3
Enrollment Rate
Number participants enrolled / Number screened positive \& eligible. A rate of at least 75% will indicate feasibility.
Time frame
At screening4
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.
Time frame
Up to 2 monthsSecondary outcomes
1
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.
Time frame
Up to 2 months2
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).
Time frame
Up to 5 months3
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.
Time frame
Up to 5 months4
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.
Time frame
Up to 5 monthsSponsors and contacts
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Source ClinicalTrials.gov