Testing Home-based Exercise Strategies to Improve Exercise Participation and Cardiovascular Health in Underserved Minority Patients With Cancer Undergoing Chemotherapy: the THRIVE Study
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Sponsor
- Dana-Farber Cancer Institute
- Enrollment
- 135
- Locations
- 2
- Primary Endpoint
- Change in Physical Activity Participation
Study Overview
Brief Summary
The purpose of this research is to determine 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.
The names of the study interventions involved in this study are:
- Supervised aerobic and resistance exercise (SUP) - virtually supervised 16- week aerobic and resistance exercise performed at home via Zoom.
- Unsupervised aerobic and resistance exercise (UNSUP) - home-based 16- week aerobic and resistance exercise.
- Attention control (AC) - 16-week home-based stretching.
Detailed Description
This is a randomized control trial of Black and Hispanic patients who have been newly diagnosed with breast, colorectal, or prostate cancer and are being prescribed chemotherapy to determine the effects of home-based exercise on levels of physical activity. It will also evaluate the impact of home-based exercise on cardiovascular (heart health) risk factors.
The research study procedures include: screening for eligibility and study treatment including evaluations of body composition, blood tests, fitness and strength assessments, and surveys at study entry and follow-up visits.
Participants in this study will be randomly assigned to one of three groups: 1) Supervised aerobic and resistance exercise (SUP), 2) Unsupervised aerobic and resistance exercise (UNSUP), or 3) Attention control (AC).
Participation is expected to last for 8 months.
It is expected that about 135 people will take part in this research study.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Supportive Care
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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.
Arms & Interventions
Supervised aerobic and resistance exercise (SUP)
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.
Intervention: Supervised Home-Based Exercise (Behavioral)
Unsupervised aerobic and resistance exercise (UNSUP)
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.
Intervention: Unsupervised Home-Based Exercise (Behavioral)
Attention Control (AC)
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.
Intervention: Attention Control (Behavioral)
Outcomes
Primary Outcomes
Change in Physical Activity Participation
Time Frame: Evaluated at week 1 for baseline, week 16 for post-intervention assessment, and week 32 for follow-up
Changes from baseline in physical activity participation measured by Godin Leisure-Time Exercise Questionnaire.
Secondary Outcomes
- Cardiopulmonary Fitness(Evaluated at week 1 for baseline, week 9 for mid-point, week 16 for post-intervention assessment, and week 32 for follow-up)
- Physical Fitness(Evaluated at week 1 for baseline, week 16 for post-intervention assessment, and week 32 for follow-up)
- Patient Reported Outcomes - Sleep(Evaluated at week 1 for baseline, week 16 for post-intervention assessment, and week 32 for follow-up)
- Augmentation Index(Time Frame: Evaluated at week 1 for baseline, week 16 for post-intervention assessment, and week 32 for follow-up)
- Biomarkers for Cardiovascular and Metabolic Health - glucose(Evaluated at week 1 for baseline, week 16 for post-intervention assessment, and week 32 for follow-up)
- Biomarkers for Cardiovascular and Metabolic Health - HbA1c(Evaluated at week 1 for baseline, week 16 for post-intervention assessment, and week 32 for follow-up.)
- Cardiorespiratory Fitness(Evaluated at week 1 for baseline, week 16 for post-intervention assessment, and week 32 for follow-up)
- Blood Pressure(Evaluated at week 1 for baseline, week 16 for post-intervention assessment, and week 32 for follow-up)
- Muscular Strength(Evaluated at week 1 for baseline, week 9 for mid-point, week 16 for post-intervention assessment, and week 32 for follow-up)
- Patient Reported Outcomes - Symptoms(Evaluated at week 1 for baseline, week 16 for post-intervention assessment, and week 32 for follow-up)
- Biomarkers for Cardiovascular and Metabolic Health - insulin(Evaluated at week 1 for baseline, week 16 for post-intervention assessment, and week 32 for follow-up)
- Body Composition(Evaluated at week 1 for baseline, week 16 for post-intervention assessment, and week 32 for follow-up)
- Patient Reported Outcomes - Health-related domains(Evaluated at week 1 for baseline, week 16 for post-intervention assessment, and week 32 for follow-up)
- Dietary Assessment(Evaluated at week 1 for baseline, week 16 for post-intervention assessment, and week 32 for follow-up)
- Feasibility of Intervention Questionnaire Ratings(Evaluated at months 2 and 4)
- Biomarkers for Cardiovascular and Metabolic Health - c-reactive protein(Evaluated at week 1 for baseline, week 16 for post-intervention assessment, and week 32 for follow-up.)
- Patient Reported Outcomes - Quality of Life(Evaluated at week 1 for baseline, week 16 for post-intervention assessment, and week 32 for follow-up)
- Acceptability of Intervention Questionnaire Ratings(Evaluated at months 2 and 4)
- Biomarkers for Cardiovascular and Metabolic Health - c-peptide(Evaluated at week 1 for baseline, week 16 for post-intervention assessment, and week 32 for follow-up.)
Investigators
Christina Dieli-Conwright, PhD
Principal Investigator
Dana-Farber Cancer Institute