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

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05327452
• Other study ID #: 21-559
• Secondary ID: 2U54CA156732-11
• Status: Recruiting
• Phase: N/A
• Start date: October 31, 2022
• Est. completion date: January 31, 2025

Study information

• Verified date: November 2023
• Source: Dana-Farber Cancer Institute
• Contact: Christina Dieli-Conwright, PhD, MPH
• Phone: 617-582-8321
• Email: ChristinaM_Dieli-Conwright[@]dfci.harvard.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• 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.

Related Conditions & MeSH terms

• Breast Cancer
• Colorectal Cancer
• Colorectal Neoplasms
• Prostate Cancer
• Prostatic Neoplasms

Intervention

Behavioral:
• Supervised Home-Based Exercise
Online supervised aerobic and resistance exercise
• Unsupervised Home-Based Exercise
Unsupervised aerobic and resistance exercise (UNSUP)
• Attention Control
Stretching Program

Locations

Country	Name	City	State
United States	Brigham and Women's Hospital	Boston	Massachusetts
United States	Dana Farber Cancer Institute	Boston	Massachusetts

Sponsors (3)

Lead Sponsor	Collaborator
Dana-Farber Cancer Institute	National Cancer Institute (NCI), University of Massachusetts, Boston

Country where clinical trial is conducted

United States, 

Outcome

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.