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

Clinicaltrials.gov ID: NCT05327452
db-list-check Status RECRUITING
b-loader Phase NA
b-people Age ≥ 18 Years
b-bullseye-arrow Enrollments 135

Conditions

Breast Cancer, Colorectal Cancer, Prostate Cancer

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.

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.

Locations

2 locations Found with status Recruiting

Status

  • RECRUITING

Contact Person

Principal Investigator

  • Christina Dieli-Conwright, PhD, MPH

Status

  • RECRUITING

Contact Person

Principal Investigator

  • Christina Dieli-Conwright, PhD, MPH

Eligibility Criteria

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

Supervised aerobic and resistance exercise (SUP)

EXPERIMENTAL

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.nnParticipants 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

    Description:

    Online supervised aerobic and resistance exercise

Unsupervised aerobic and resistance exercise (UNSUP)

EXPERIMENTAL

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.nnParticipants 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

    Description:

    Unsupervised aerobic and resistance exercise (UNSUP)

Attention Control (AC)

ACTIVE_COMPARATOR

Participants will be randomly assigned to receive 3x weekly at home stretching exercise for 16 weeks.nnParticipants will also have a baseline test, mid intervention cardiovascular and strength tests and one postintervention and one follow up visit.

  • BEHAVIORAL:

    Attention Control

    Description:

    Stretching Program

Outcome Measures

Primary Outcome Measures

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

Secondary Outcome Measures

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

Blood Pressure

Time Frame: 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

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

Physical Fitness

Time Frame: 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

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

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

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

Patient Reported Outcomes - Sleep

Time Frame: 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

Dietary Assessment

Time Frame: 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

Feasibility of Intervention Questionnaire Ratings

Time Frame: 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

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

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.

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.

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.

Timeline

  • Last Updated
    June 27, 2024
  • Start Date
    April 14, 2022
  • Today
    February 5, 2025
  • Completion Date ( Estimated )
    December 31, 2025

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