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Home-Based Exercise for Cancer Patients
N/A
Recruiting
Led By Christina Dieli-Conwright, PhD, MPH
Research Sponsored by Dana-Farber Cancer Institute
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Newly diagnosed with stage I-III breast, colorectal or prostate cancer
Over 18 years old; children under the age of 18 will be excluded due to rarity of disease
Must not have
Patients should not have any uncontrolled illness including ongoing or active infection, uncontrolled diabetes, hypertension, or thyroid disease
Patients with metastatic disease
Timeline
Screening 3 weeks
Treatment Varies
Follow Up evaluated at months 2 and 4
Awards & highlights
No Placebo-Only Group
Summary
This trial will test whether a 16-week, home-based, aerobic and resistance exercise intervention will increase physical activity levels in Black and Hispanic breast, colorectal, or prostate cancer patients.
Who is the study for?
This trial is for Black and Hispanic adults over 18 with stage I-III breast, colorectal, or prostate cancer who are overweight/obese. They must be starting chemotherapy soon, speak English/Spanish, do less than 90 minutes of exercise per week, and can visit Dana-Farber Cancer Institute for data collection.
What is being tested?
The THRIVE Study tests if a 16-week home-based exercise program (either supervised via Zoom or unsupervised) improves physical activity in minority cancer patients compared to a control group doing stretching exercises.
What are the potential side effects?
Potential side effects from the exercise programs may include typical risks associated with physical activity such as muscle strains or sprains. However, these activities are designed considering participants' health status.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I have been recently diagnosed with early to mid-stage breast, colorectal, or prostate cancer.
Select...
I am over 18 years old.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I do not have any uncontrolled illnesses like infections or diabetes.
Select...
My cancer has spread to other parts of my body.
Select...
I have another active cancer besides the one being treated.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ evaluated at months 2 and 4
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~evaluated at months 2 and 4
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Change in Physical Activity Participation
Secondary study objectives
Acceptability of Intervention Questionnaire Ratings
Augmentation Index
Biomarkers for Cardiovascular and Metabolic Health - HbA1c
+16 moreAwards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
3Treatment groups
Experimental Treatment
Active Control
Group I: Unsupervised aerobic and resistance exercise (UNSUP)Experimental Treatment1 Intervention
Participants will be randomly assigned to receive 3x weekly at home, unsupervised aerobic and resistance exercise sessions with a 1x weekly telehealth call with a certified exercise trainer for 16 weeks.
Participants will also have a baseline test, mid intervention cardiovascular and strength tests and one postintervention and one follow up visit.
Group II: Supervised aerobic and resistance exercise (SUP)Experimental Treatment1 Intervention
Participants will be randomly assigned to receive 3x weekly at home, virtually supervised aerobic and resistance exercise sessions with a certified exercise trainer for 16 weeks.
Participants will also have a baseline test, mid intervention cardiovascular and strength tests and one postintervention and one follow up visit.
Group III: Attention Control (AC)Active Control1 Intervention
Participants will be randomly assigned to receive 3x weekly at home stretching exercise for 16 weeks.
Participants will also have a baseline test, mid intervention cardiovascular and strength tests and one postintervention and one follow up visit.
Find a Location
Who is running the clinical trial?
University of Massachusetts, BostonOTHER
36 Previous Clinical Trials
15,643 Total Patients Enrolled
National Cancer Institute (NCI)NIH
13,956 Previous Clinical Trials
41,111,958 Total Patients Enrolled
Dana-Farber Cancer InstituteLead Sponsor
1,113 Previous Clinical Trials
358,614 Total Patients Enrolled
Christina Dieli-Conwright, PhD, MPHPrincipal InvestigatorDana-Farber Cancer Institute
4 Previous Clinical Trials
1,748 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You are required to do structured exercise for more than 90 minutes per week.I started chemotherapy less than 4 weeks ago.I do not have any uncontrolled illnesses like infections or diabetes.You are overweight or obese, which means you have too much body fat.I have a condition affecting my muscles, bones, heart, or lungs.I have been recently diagnosed with early to mid-stage breast, colorectal, or prostate cancer.My cancer has spread to other parts of my body.You identify yourself as Hispanic or Black.I am over 18 years old.I speak English or Spanish.I have another active cancer besides the one being treated.You are not physically active and do not exercise for at least 90 minutes per week.
Research Study Groups:
This trial has the following groups:- Group 1: Unsupervised aerobic and resistance exercise (UNSUP)
- Group 2: Supervised aerobic and resistance exercise (SUP)
- Group 3: Attention Control (AC)
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.