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

NCT ID: NCT05327452

Last Updated: 2026-01-21

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

NA

Total Enrollment

135 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-10-31

Study Completion Date

2027-05-31

Brief Summary

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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

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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.

Conditions

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Breast Cancer Colorectal Cancer Prostate Cancer

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

Supervised Home-Based Exercise

Intervention Type BEHAVIORAL

Online supervised aerobic and resistance exercise

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.

Group Type EXPERIMENTAL

Unsupervised Home-Based Exercise

Intervention Type BEHAVIORAL

Unsupervised aerobic and resistance exercise (UNSUP)

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.

Group Type ACTIVE_COMPARATOR

Attention Control

Intervention Type BEHAVIORAL

Stretching Program

Interventions

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Supervised Home-Based Exercise

Online supervised aerobic and resistance exercise

Intervention Type BEHAVIORAL

Unsupervised Home-Based Exercise

Unsupervised aerobic and resistance exercise (UNSUP)

Intervention Type BEHAVIORAL

Attention Control

Stretching Program

Intervention Type BEHAVIORAL

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Cancer Institute (NCI)

NIH

Sponsor Role collaborator

University of Massachusetts, Boston

OTHER

Sponsor Role collaborator

Dana-Farber Cancer Institute

OTHER

Sponsor Role lead

Responsible Party

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Christina Dieli-Conwright, PhD

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Christina Dieli-Conwright, PhD, MPH

Role: PRINCIPAL_INVESTIGATOR

Dana-Farber Cancer Institute

Locations

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Brigham and Women's Hospital

Boston, Massachusetts, United States

Site Status

Dana Farber Cancer Institute

Boston, Massachusetts, United States

Site Status

Countries

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United States

References

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Yan H, Gonzalo-Encabo P, Wilson RL, Christopher CN, Cannon JD, Kang DW, Gardiner J, Perez M, Norris MK, Gundersen D, Hayman LL, Freedman RA, Rebbeck TR, Shi L, Dieli-Conwright CM. Testing home-based exercise strategies in underserved minority cancer patients undergoing chemotherapy (THRIVE) trial: a study protocol. Front Oncol. 2024 Sep 16;14:1427046. doi: 10.3389/fonc.2024.1427046. eCollection 2024.

Reference Type DERIVED
PMID: 39351353 (View on PubMed)

Other Identifiers

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2U54CA156732-11

Identifier Type: NIH

Identifier Source: secondary_id

View Link

21-559

Identifier Type: -

Identifier Source: org_study_id

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