Breast Cancer Clinical Trial
Official title:
Testing Home-based Exercise Strategies to Improve Exercise Participation and Cardiovascular Health in Underserved Minority Patients With Cancer Undergoing Chemotherapy: the THRIVE Study
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.
Status | Recruiting |
Enrollment | 135 |
Est. completion date | January 31, 2025 |
Est. primary completion date | December 31, 2024 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | 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. |
Country | Name | City | State |
---|---|---|---|
United States | Brigham and Women's Hospital | Boston | Massachusetts |
United States | Dana Farber Cancer Institute | Boston | Massachusetts |
Lead Sponsor | Collaborator |
---|---|
Dana-Farber Cancer Institute | National Cancer Institute (NCI), University of Massachusetts, Boston |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | 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 | |
Secondary | 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 | |
Secondary | 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 | |
Secondary | 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 | |
Secondary | 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 | |
Secondary | 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 | |
Secondary | 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 | |
Secondary | 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 | |
Secondary | 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 | |
Secondary | 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 | |
Secondary | 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 | |
Secondary | 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 | |
Secondary | 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 | |
Secondary | 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 | |
Secondary | 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 | |
Secondary | 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 | |
Secondary | 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. | |
Secondary | 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. | |
Secondary | 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. |
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