Breast Cancer Clinical Trial
Testing Home-based Exercise Strategies in Underserved Minority Cancer Patients Undergoing Chemotherapy: the THRIVE Study
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.
Full 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.
Eligibility 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.
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