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

Last updated: June 26, 2024
Sponsor: Dana-Farber Cancer Institute
Overall Status: Active - Recruiting

Phase

N/A

Condition

Prostate Cancer

Rectal Cancer

Prostate Cancer, Early, Recurrent

Treatment

Unsupervised Home-Based Exercise

Attention Control

Supervised Home-Based Exercise

Clinical Study ID

NCT05327452
21-559
2U54CA156732-11
  • Ages > 18
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Over 18 years old; children under the age of 18 will be excluded due to rarity ofdisease

  • 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 consentdocument.

Exclusion

Exclusion Criteria:

  • Pre-existing musculoskeletal or cardiorespiratory conditions

  • Patients should not have any uncontrolled illness including ongoing or activeinfection, 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 thesafety monitoring requirements of the study.

Study Design

Total Participants: 135
Treatment Group(s): 3
Primary Treatment: Unsupervised Home-Based Exercise
Phase:
Study Start date:
October 31, 2022
Estimated Completion Date:
December 31, 2025

Study 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.

Connect with a study center

  • Brigham and Women's Hospital

    Boston, Massachusetts 02115
    United States

    Active - Recruiting

  • Dana Farber Cancer Institute

    Boston, Massachusetts 02215
    United States

    Active - Recruiting

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