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

January 20, 2026 updated by: Christina Dieli-Conwright, PhD, Dana-Farber Cancer Institute

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.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Estimated)

135

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Massachusetts
      • Boston, Massachusetts, United States, 02115
        • Brigham and Women's Hospital
      • Boston, Massachusetts, United States, 02215
        • Dana Farber Cancer Institute

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Supervised aerobic and resistance exercise (SUP)

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
Online supervised aerobic and resistance exercise
Experimental: Unsupervised aerobic and resistance exercise (UNSUP)

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
Unsupervised aerobic and resistance exercise (UNSUP)
Active Comparator: Attention Control (AC)

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
Stretching Program

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Physical Activity Participation
Time Frame: Evaluated at week 1 for baseline, week 16 for post-intervention assessment, and week 32 for follow-up
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
Time Frame: Evaluated at week 1 for baseline, week 16 for post-intervention assessment, and week 32 for follow-up
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
Time Frame: Evaluated at week 1 for baseline, week 16 for post-intervention assessment, and week 32 for follow-up
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
Time Frame: Evaluated at week 1 for baseline, week 16 for post-intervention assessment, and week 32 for follow-up
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
Time Frame: Evaluated at week 1 for baseline, week 9 for mid-point, week 16 for post-intervention assessment, and week 32 for follow-up
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
Time Frame: Evaluated at week 1 for baseline, week 16 for post-intervention assessment, and week 32 for follow-up
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
Time Frame: Evaluated at week 1 for baseline, week 16 for post-intervention assessment, and week 32 for follow-up
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
Time Frame: Evaluated at week 1 for baseline, week 9 for mid-point, week 16 for post-intervention assessment, and week 32 for follow-up
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
Time Frame: Evaluated at week 1 for baseline, week 16 for post-intervention assessment, and week 32 for follow-up
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
Time Frame: Evaluated at week 1 for baseline, week 16 for post-intervention assessment, and week 32 for follow-up
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
Time Frame: Evaluated at week 1 for baseline, week 16 for post-intervention assessment, and week 32 for follow-up
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
Time Frame: Evaluated at week 1 for baseline, week 16 for post-intervention assessment, and week 32 for follow-up
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
Time Frame: Evaluated at week 1 for baseline, week 16 for post-intervention assessment, and week 32 for follow-up
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
Time Frame: Evaluated at months 2 and 4
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
Time Frame: Evaluated at months 2 and 4
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
Time Frame: Time Frame: Evaluated at week 1 for baseline, week 16 for post-intervention assessment, and week 32 for follow-up
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
Time Frame: Evaluated at week 1 for baseline, week 16 for post-intervention assessment, and week 32 for follow-up
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
Time Frame: Evaluated at week 1 for baseline, week 16 for post-intervention assessment, and week 32 for follow-up.
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
Time Frame: Evaluated at week 1 for baseline, week 16 for post-intervention assessment, and week 32 for follow-up.
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
Time Frame: Evaluated at week 1 for baseline, week 16 for post-intervention assessment, and week 32 for follow-up.
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.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Dana-Farber Cancer Institute

Collaborators

National Cancer Institute (NCI)
University of Massachusetts, Boston

Investigators

  • Principal Investigator: Christina Dieli-Conwright, PhD, MPH, Dana-Farber Cancer Institute

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 31, 2022

Primary Completion (Estimated)

December 31, 2026

Study Completion (Estimated)

May 31, 2027

Study Registration Dates

First Submitted

March 11, 2022

First Submitted That Met QC Criteria

April 11, 2022

First Posted (Actual)

April 14, 2022

Study Record Updates

Last Update Posted (Actual)

January 21, 2026

Last Update Submitted That Met QC Criteria

January 20, 2026

Last Verified

January 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 21-559
  • 2U54CA156732-11 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

The Dana-Farber / Harvard Cancer Center encourages and supports the responsible and ethical sharing of data from clinical trials. De-identified participant data from the final research dataset used in the published manuscript may only be shared under the terms of a Data Use Agreement. Requests may be directed to: [contact information for Sponsor Investigator or designee]. The protocol and statistical analysis plan will be made available on Clinicaltrials.gov only as required by federal regulation or as a condition of awards and agreements supporting the research.

IPD Sharing Time Frame

Data can be shared no earlier than 1 year following the date of publication

IPD Sharing Access Criteria

Contact the Belfer Office for Dana-Farber Innovations (BODFI) at innovation@dfci.harvard.edu

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ICF

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Breast Cancer

Clinical Trials on Supervised Home-Based Exercise

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Estonia

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe