Ignite Creation Date:
2024-05-06 @ 7:33 PM
Last Modification Date:
2024-10-26 @ 3:09 PM
Study NCT ID:
NCT06052488
Status:
RECRUITING
Last Update Posted:
2024-02-08
First Post:
2023-09-12
Brief Title:
Strength After Breast Cancer
Sponsor:
MGH Institute of Health Professions
Organization:
MGH Institute of Health Professions
Study Overview
Official Title:
Strength After Breast Cancer Clinical Implementation of an Evidence-based Group Exercise Intervention for Breast Cancer Survivors
Status:
RECRUITING
Status Verified Date:
2024-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
SABC
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
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
- 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None