Testing Home-based Exercise Strategies in Underserved Minority Cancer Patients Undergoing Chemotherapy: the THRIVE Study
Conditions
Breast Cancer, Colorectal Cancer, Prostate CancerSummary
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.
Locations
2 locations Found with status Recruiting
Status
- RECRUITING
Contact Person
- Christina Dieli-Conwright, PhD, MPH
- 617-582-8321
- [email protected]
Principal Investigator
- Christina Dieli-Conwright, PhD, MPH
Status
- RECRUITING
Contact Person
- Christina Dieli-Conwright, PhD, MPH
- 617-632-3800
- [email protected]
Principal Investigator
- Christina Dieli-Conwright, PhD, MPH
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.
Study Plan
Supervised aerobic and resistance exercise (SUP)
EXPERIMENTAL
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.nnParticipants will also have a baseline test, mid intervention cardiovascular and strength tests and one postintervention and one follow up visit.
BEHAVIORAL:
Supervised Home-Based ExerciseDescription:
Online supervised aerobic and resistance exercise
Unsupervised aerobic and resistance exercise (UNSUP)
EXPERIMENTAL
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.nnParticipants will also have a baseline test, mid intervention cardiovascular and strength tests and one postintervention and one follow up visit.
BEHAVIORAL:
Unsupervised Home-Based ExerciseDescription:
Unsupervised aerobic and resistance exercise (UNSUP)
Attention Control (AC)
ACTIVE_COMPARATOR
Participants will be randomly assigned to receive 3x weekly at home stretching exercise for 16 weeks.nnParticipants will also have a baseline test, mid intervention cardiovascular and strength tests and one postintervention and one follow up visit.
BEHAVIORAL:
Attention ControlDescription:
Stretching Program
Outcome Measures
Primary Outcome Measures
Change in Physical Activity Participation
Secondary Outcome Measures
Biomarkers for Cardiovascular and Metabolic Health - insulin
Blood Pressure
Body Composition
Cardiopulmonary Fitness
Physical Fitness
Cardiorespiratory Fitness
Muscular Strength
Patient Reported Outcomes - Quality of Life
Patient Reported Outcomes - Health-related domains
Patient Reported Outcomes - Sleep
Patient Reported Outcomes - Symptoms
Dietary Assessment
Acceptability of Intervention Questionnaire Ratings
Feasibility of Intervention Questionnaire Ratings
Augmentation Index
Biomarkers for Cardiovascular and Metabolic Health - glucose
Biomarkers for Cardiovascular and Metabolic Health - HbA1c
Biomarkers for Cardiovascular and Metabolic Health - c-peptide
Biomarkers for Cardiovascular and Metabolic Health - c-reactive protein
Timeline
Last Updated
June 27, 2024Start Date
April 14, 2022Today
February 5, 2025Completion Date ( Estimated )
December 31, 2025
Sponsors of this trial
Lead Sponsor
Dana-Farber Cancer InstituteCollaborating Sponsors
National Cancer Institute (NCI), University of Massachusetts, Boston