Home-based exercise program for minority cancer patients undergoing chemotherapy
Testing Home-based Exercise Strategies to Improve Exercise Participation and Cardiovascular Health in Underserved Minority Patients With Cancer Undergoing Chemotherapy: the THRIVE Study
This study tests whether a 16-week home exercise program can help Black and Hispanic cancer patients starting chemotherapy become more active and improve their overall health.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 135 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Dana-Farber Cancer Institute Academic / other |
| Drugs / interventions | chemotherapy |
| Locations | 2 sites (Boston, Massachusetts and 1 other locations) |
| Trial ID | NCT05327452 on ClinicalTrials.gov |
What this trial studies
This research aims to evaluate the effectiveness of a 16-week home-based exercise intervention on increasing physical activity levels among Black and Hispanic patients newly diagnosed with breast, colorectal, or prostate cancer who are starting chemotherapy. Participants will be randomly assigned to one of three groups: supervised aerobic and resistance exercise, unsupervised exercise, or an attention control group focusing on stretching. The study will also assess the impact of these exercise interventions on cardiovascular health and overall fitness. Participants will undergo various evaluations, including body composition assessments and blood tests, throughout the study duration.
Who should consider this trial
Good fit: Ideal candidates include Black and Hispanic adults over 18 years old, newly diagnosed with stage I-III breast, colorectal, or prostate cancer, and starting chemotherapy.
Not a fit: Patients with pre-existing musculoskeletal or cardiorespiratory conditions or those with uncontrolled illnesses may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could enhance physical activity levels and improve health outcomes for minority cancer patients undergoing chemotherapy.
How similar studies have performed: Other studies have shown positive outcomes with home-based exercise interventions for cancer patients, indicating potential success for this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Over 18 years old; children under the age of 18 will be excluded due to rarity of disease * Newly diagnosed with stage I-III breast, colorectal or prostate cancer * Self-identify as Hispanic or Black * Are within 4 weeks of initiating chemotherapy * Overweight or obese (BMI \>25kg/m2 or body fat percent \>30) * Physician's clearance to participate in moderate-vigorous intensity exercise * Speak English or Spanish * Engaging in less than 90 minutes of moderate-or-vigorous physical activity per week * Willing to travel to Dana-Farber Cancer Institute for necessary data collection * Ability to understand and the willingness to sign a written informed consent document. Exclusion Criteria: * Pre-existing musculoskeletal or cardiorespiratory conditions * Patients should not have any uncontrolled illness including ongoing or active infection, uncontrolled diabetes, hypertension, or thyroid disease * Patients with other active malignancies * Patients with metastatic disease * Participate in more than 90 minutes of structured exercise/week * Unable to travel to Dana-Farber Cancer Institute for necessary data collection * Subjects, who in the opinion of the investigator, may not be able to comply with the safety monitoring requirements of the study.
Where this trial is running
Boston, Massachusetts and 1 other locations
- Brigham and Women's Hospital — Boston, Massachusetts, United States (Recruiting)
- Dana Farber Cancer Institute — Boston, Massachusetts, United States (Recruiting)
Study contacts
- Principal investigator: Christina Dieli-Conwright, PhD, MPH — Dana-Farber Cancer Institute
- Study coordinator: Christina Dieli-Conwright, PhD, MPH
- Email: ChristinaM_Dieli-Conwright@dfci.harvard.edu
- Phone: 617-582-8321
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.