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
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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ACTIVE_NOT_RECRUITING
NA
135 participants
INTERVENTIONAL
2022-10-31
2027-05-31
Brief Summary
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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.
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Detailed Description
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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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Study Design
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RANDOMIZED
PARALLEL
SUPPORTIVE_CARE
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.
Supervised Home-Based Exercise
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.
Unsupervised Home-Based Exercise
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.
Attention Control
Stretching Program
Interventions
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Supervised Home-Based Exercise
Online supervised aerobic and resistance exercise
Unsupervised Home-Based Exercise
Unsupervised aerobic and resistance exercise (UNSUP)
Attention Control
Stretching Program
Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
18 Years
ALL
No
Sponsors
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National Cancer Institute (NCI)
NIH
University of Massachusetts, Boston
OTHER
Dana-Farber Cancer Institute
OTHER
Responsible Party
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Christina Dieli-Conwright, PhD
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
Dana Farber Cancer Institute
Boston, Massachusetts, United States
Countries
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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.
Other Identifiers
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21-559
Identifier Type: -
Identifier Source: org_study_id
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