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Cardiac Rehab for Breast Cancer Survivors (CRIBCO Trial)
N/A
Recruiting
Led By David Lipps, PhD
Research Sponsored by University of Michigan Rogel Cancer Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Age 18 years or older
Breast cancer diagnosis stage I-III
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 12 weeks after enrollment
Awards & highlights
CRIBCO Trial Summary
This trial seeks to develop a new rehab program for breast cancer survivors to reduce their risk of heart disease, using fewer visits than usual. #cardiacrehab
Who is the study for?
This trial is for breast cancer survivors, aged 18 or older, who have completed their main treatments within the last 18 months and are at risk of developing cardiovascular disease. Participants must be able to exercise and give informed consent. Those with metastatic cancer, high-risk heart conditions under treatment, planned surgeries during the study period, or inability to consent are excluded.Check my eligibility
What is being tested?
The trial is testing a new cardiac rehabilitation program designed specifically for breast cancer survivors at risk of heart disease. It involves attending 12 rehab sessions over eight weeks and aims to improve heart health without overburdening the existing cardiac rehab services meant for patients with severe heart conditions.See study design
What are the potential side effects?
Since this intervention involves exercise as part of cardiac rehabilitation, potential side effects may include muscle soreness, fatigue, and in rare cases exercise-related injuries. The program's safety will be closely monitored throughout the trial.
CRIBCO Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am 18 years old or older.
Select...
My breast cancer is at an early to mid-stage (I-III).
CRIBCO Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 12 weeks after enrollment
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 12 weeks after enrollment
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Change in cardiovascular fitness (as assessed using VO2max) between baseline and after 12 weeks of participation in a tapered 12-week cardiac rehabilitation program.
Secondary outcome measures
changes in lower body strength between baseline and after a 12-week hybrid cardiac rehabilitation program.
changes in upper body strength between baseline and after a 12-week hybrid cardiac rehabilitation program.
CRIBCO Trial Design
1Treatment groups
Experimental Treatment
Group I: Cardiac Rehabilitation to Improve Breast Cancer OutcomesExperimental Treatment1 Intervention
12 weeks of Cardiac Rehab
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Who is running the clinical trial?
University of Michigan Rogel Cancer CenterLead Sponsor
294 Previous Clinical Trials
24,231 Total Patients Enrolled
David Lipps, PhDPrincipal InvestigatorUniversity of Michigan Rogel Cancer Center
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- My cancer has spread to other parts of my body.I am scheduled for surgery during the study.You are not able to do physical activity.I am 18 years old or older.I am at high risk for heart disease.My breast cancer is at an early to mid-stage (I-III).I am under care for a serious heart condition.I finished my cancer treatments except for oral maintenance less than 18 months ago.
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Research Study Groups:
This trial has the following groups:- Group 1: Cardiac Rehabilitation to Improve Breast Cancer Outcomes
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Is this research actively seeking participants?
"According to the listing on clinicaltrials.gov, recruitment for this trial has concluded; it was initially posted on July 1st 2023 and most recently updated on May 10th 2023. Notwithstanding, there are still 3106 medical studies that need volunteers at present."
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