Skip to main content
OpenTrials
Active, Not Recruiting

NCT Number: NCT05327452

Testing Home-based Exercise Strategies in Underserved Minority Cancer Patients 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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Notify Me

Key information

Conditions

Breast Cancer Breast Diseases Breast Neoplasms Colonic Diseases Colorectal Cancer Colorectal Neoplasms Digestive System Diseases Digestive System Neoplasms Gastrointestinal Diseases Gastrointestinal Neoplasms Genital Diseases Genital Diseases, Male Genital Neoplasms, Male Intestinal Diseases Intestinal Neoplasms Male Urogenital Diseases Neoplasms Neoplasms by Site Prostate Cancer Prostatic Diseases Prostatic Neoplasms Rectal Diseases Skin Diseases Skin and Connective Tissue Diseases Urogenital Diseases Urogenital Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Brigham and Women's Hospital, Boston, Massachusetts, United States

Loading trial locations.

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Supervised home-based exercise

Behavioral

Online supervised aerobic and resistance exercise

Unsupervised Home-Based Exercise

Behavioral

Unsupervised aerobic and resistance exercise (UNSUP)

Attention Control

Behavioral

Stretching Program

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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).

  6. 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.

  7. 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.

  8. 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.

  9. 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.

  10. 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).

  11. 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.

  12. 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.

  13. 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.

  14. 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.

  15. 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.

  16. 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.

  17. 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.

  18. 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.

  19. 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.

Sponsors and collaborators

Lead sponsor

Dana-Farber Cancer Institute

Other

Collaborators

  • National Cancer Institute (NCI)
  • University of Massachusetts, Boston

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2026
Study completion
2027
First posted
Apr 14, 2022
Registry last updated
Jan 21, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.