Ignite Creation Date:
2025-12-24 @ 4:52 PM
Ignite Modification Date:
2025-12-30 @ 7:03 AM
Study NCT ID:
NCT04717050
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2025-07-10
First Post:
2021-01-19
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Reducing Metabolic Dysregulation in Obese Latina Breast Cancer Survivors Using Physical Activity
Sponsor:
Dana-Farber Cancer Institute
Organization:
Study Overview
Official Title:
Reducing Metabolic Dysregulation in Obese Latina Breast Cancer Survivors Using Physical Activity: The ROSA Trial
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2025-07
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:
None
Brief Summary:
This study is about testing whether exercise will improve fitness and lessen risk factors related to heart disease, diabetes, and obesity in Latina breast cancer survivors.
Detailed Description:
This research study is a Phase II clinical trial. Phase II clinical trials test the safety and effectiveness of an investigational intervention to learn whether the intervention works in treating a specific disease. "Investigational" means that the intervention is being studied. The purpose of this research is to determine whether a 16-week exercise program will improve fitness and lessen risk factors related to coronary artery disease, stroke, and type 2 diabetes in patients who have breast cancer and is sustainable for a Latina population to incorporate into their lifestyle following completion of the 16-week intervention.
The research study procedures include screening for eligibility and study treatment including evaluations and follow up visits.
Participants in this study will be randomly assigned into one of the study groups: Progressive Combine Training (PCT) or Attention Control.
* Progressive combined training (PCT) will be performed in 2 phases:
1. supervised 16-week resistance and cardiovascular exercise at a local YMCA (months 1-4) or remotely at home via Zoom.
2. unsupervised 16-week resistance and cardiovascular exercise at a local YMCA (months 5-8) or remotely at home with weekly check-ins with trainer.
* Attention Control Group: 51 weeks home-based stretching
All participants will undergo seven blood draws and participate in nine testing visits.
Participation is expected to last 12 months for all participants.
It is expected that about 160 people will take part in this research study.
The American Cancer Society is supporting this research study by providing funding for the research study.
The research study procedures include screening for eligibility and study treatment including evaluations and follow up visits.
Participants in this study will be randomly assigned into one of the study groups: Progressive Combine Training (PCT) or Attention Control.
* Progressive combined training (PCT) will be performed in 2 phases:
1. supervised 16-week resistance and cardiovascular exercise at a local YMCA (months 1-4) or remotely at home via Zoom.
2. unsupervised 16-week resistance and cardiovascular exercise at a local YMCA (months 5-8) or remotely at home with weekly check-ins with trainer.
* Attention Control Group: 51 weeks home-based stretching
All participants will undergo seven blood draws and participate in nine testing visits.
Participation is expected to last 12 months for all participants.
It is expected that about 160 people will take part in this research study.
The American Cancer Society is supporting this research study by providing funding for the research study.
Study Oversight
Has Oversight DMC:
True
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?: