Testing Home-based Exercise Strategies in Underserved Minority Cancer Patients Undergoing Chemotherapy: the THRIVE Study

Study Overview
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Brief Summary
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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
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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.

Official Title
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Testing Home-based Exercise Strategies to Improve Exercise Participation and Cardiovascular Health in Underserved Minority Patients With Cancer Undergoing Chemotherapy: the THRIVE Study

Conditions
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Breast Cancer, Colorectal Cancer, Prostate Cancer

Intervention / Treatment
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* Behavioral: Supervised Home-Based Exercise
* Behavioral: Unsupervised Home-Based Exercise
* Behavioral: Attention Control


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Supervised aerobic and resistance exercise (SUP)<br>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. | Behavioral: Supervised Home-Based Exercise<br>* Online supervised aerobic and resistance exercise<br>|
| Experimental: Unsupervised aerobic and resistance exercise (UNSUP)<br>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. | Behavioral: Unsupervised Home-Based Exercise<br>* Unsupervised aerobic and resistance exercise (UNSUP)<br>|
| Active Comparator: Attention Control (AC)<br>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. | Behavioral: Attention Control<br>* Stretching Program<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Physical Activity Participation | Changes from baseline in physical activity participation measured by Godin Leisure-Time Exercise Questionnaire. | Evaluated at week 1 for baseline, week 16 for post-intervention assessment, and week 32 for follow-up | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Biomarkers for Cardiovascular and Metabolic Health - insulin | Fasting blood will be drawn from the antecubital vein by a trained phlebotomist. Insulin will be measured. | Evaluated at week 1 for baseline, week 16 for post-intervention assessment, and week 32 for follow-up | 
| Blood Pressure | Blood pressure will be assessed using an automated blood pressure cuff to measure both systolic and diastolic blood pressure. | Evaluated at week 1 for baseline, week 16 for post-intervention assessment, and week 32 for follow-up | 
| Body Composition | Body composition (lean mass and fat mass) will be assessed via bioelectrical impedance using a validated scale. | Evaluated at week 1 for baseline, week 16 for post-intervention assessment, and week 32 for follow-up | 
| Cardiopulmonary Fitness | Cardiopulmonary fitness will be measured by a submaximal graded exercise cycling test. | 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 | Physical Fitness will be measured by the short physical performance battery (SPPB). | Evaluated at week 1 for baseline, week 16 for post-intervention assessment, and week 32 for follow-up | 
| Cardiorespiratory Fitness | Cardiorespiratory fitness will be assessed by the 6-minute walk test. | Evaluated at week 1 for baseline, week 16 for post-intervention assessment, and week 32 for follow-up | 
| Muscular Strength | Muscular strength will be assessed with a 10 repetition maximum test. | 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 - Quality of Life | Quality of life will be assessed by EORTC QLQ C-30. | Evaluated at week 1 for baseline, week 16 for post-intervention assessment, and week 32 for follow-up | 
| Patient Reported Outcomes - Health-related domains | Health-related domains of patient reported outcomes will be assessed by PROMIS-29 Profile v2.1. | Evaluated at week 1 for baseline, week 16 for post-intervention assessment, and week 32 for follow-up | 
| Patient Reported Outcomes - Sleep | Quality of life will be assessed by the Pittsburg Sleep Quality Index (PSQI). | Evaluated at week 1 for baseline, week 16 for post-intervention assessment, and week 32 for follow-up | 
| Patient Reported Outcomes - Symptoms | Symptomatic toxicities will be assessed by PRO-CTCAE. | Evaluated at week 1 for baseline, week 16 for post-intervention assessment, and week 32 for follow-up | 
| Dietary Assessment | Dietary recall will be used to assess recent dietary patterns for two weekdays and one weekend day using NutriBase 11. | Evaluated at week 1 for baseline, week 16 for post-intervention assessment, and week 32 for follow-up | 
| Acceptability of Intervention Questionnaire Ratings | Intervention acceptability and feasibility will be assessed via Acceptability of Intervention and Feasibility of Intervention questionnaires. Items are measured on a 5-point Likert scale (completely disagree to completely agree). Score is calculated mean. An average rating of 4 or higher will be considered feasible/acceptable. | Evaluated at months 2 and 4 | 
| Feasibility of Intervention Questionnaire Ratings | Intervention acceptability and feasibility will be assessed via Acceptability of Intervention and Feasibility of Intervention questionnaires. Items are measured on a 5-point Likert scale (completely disagree to completely agree). Score is calculated mean. An average rating of 4 or higher will be considered feasible/acceptable. | Evaluated at months 2 and 4 | 
| Augmentation Index | Augmentation index (a marker for arterial stiffness) will also be assessed using Mobil-O-Graph device. | 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 | Fasting blood will be drawn from the antecubital vein by a trained phlebotomist. Glucose will be measured. | 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 | Fasting blood will be drawn from the antecubital vein by a trained phlebotomist. HbA1c will be measured. | Evaluated at week 1 for baseline, week 16 for post-intervention assessment, and week 32 for follow-up. | 
| Biomarkers for Cardiovascular and Metabolic Health - c-peptide | Fasting blood will be drawn from the antecubital vein by a trained phlebotomist. C-peptide (biomarkers of glycemic control and insulin resistance) will be measured. | Evaluated at week 1 for baseline, week 16 for post-intervention assessment, and week 32 for follow-up. | 
| Biomarkers for Cardiovascular and Metabolic Health - c-reactive protein | Fasting blood will be drawn from the antecubital vein by a trained phlebotomist. C-reactive protein (CRP; biomarker of system inflammation) will be measured. | Evaluated at week 1 for baseline, week 16 for post-intervention assessment, and week 32 for follow-up. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Breast Cancer, Colorectal Cancer, Prostate Cancer