Testing Home-based Exercise Strategies in Underserved Minority Cancer Patients Undergoing Chemotherapy: the THRIVE Study
2 other identifiers
interventional
135
1 country
2
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable breast-cancer
Started Oct 2022
Typical duration for not_applicable breast-cancer
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 11, 2022
CompletedFirst Posted
Study publicly available on registry
April 14, 2022
CompletedStudy Start
First participant enrolled
October 31, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 31, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
May 31, 2027
January 21, 2026
January 1, 2026
4.2 years
March 11, 2022
January 20, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Change in Physical Activity Participation
Changes from baseline in physical activity participation measured by Godin Leisure-Time Exercise Questionnaire.
Evaluated at week 1 for baseline, week 16 for post-intervention assessment, and week 32 for follow-up
Secondary Outcomes (19)
Biomarkers for Cardiovascular and Metabolic Health - insulin
Evaluated at week 1 for baseline, week 16 for post-intervention assessment, and week 32 for follow-up
Blood Pressure
Evaluated at week 1 for baseline, week 16 for post-intervention assessment, and week 32 for follow-up
Body Composition
Evaluated at week 1 for baseline, week 16 for post-intervention assessment, and week 32 for follow-up
Cardiopulmonary Fitness
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
Evaluated at week 1 for baseline, week 16 for post-intervention assessment, and week 32 for follow-up
- +14 more secondary outcomes
Study Arms (3)
Supervised aerobic and resistance exercise (SUP)
EXPERIMENTALParticipants 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.
Unsupervised aerobic and resistance exercise (UNSUP)
EXPERIMENTALParticipants 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.
Attention Control (AC)
ACTIVE COMPARATORParticipants 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.
Interventions
Online supervised aerobic and resistance exercise
Unsupervised aerobic and resistance exercise (UNSUP)
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Dana-Farber Cancer Institutelead
- National Cancer Institute (NCI)collaborator
- University of Massachusetts, Bostoncollaborator
Study Sites (2)
Brigham and Women's Hospital
Boston, Massachusetts, 02115, United States
Dana Farber Cancer Institute
Boston, Massachusetts, 02215, United States
Related Publications (1)
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.
PMID: 39351353DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Christina Dieli-Conwright, PhD, MPH
Dana-Farber Cancer Institute
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
March 11, 2022
First Posted
April 14, 2022
Study Start
October 31, 2022
Primary Completion (Estimated)
December 31, 2026
Study Completion (Estimated)
May 31, 2027
Last Updated
January 21, 2026
Record last verified: 2026-01
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, ICF
- Time Frame
- Data can be shared no earlier than 1 year following the date of publication
- Access Criteria
- Contact the Belfer Office for Dana-Farber Innovations (BODFI) at innovation@dfci.harvard.edu
The Dana-Farber / Harvard Cancer Center encourages and supports the responsible and ethical sharing of data from clinical trials. De-identified participant data from the final research dataset used in the published manuscript may only be shared under the terms of a Data Use Agreement. Requests may be directed to: \[contact information for Sponsor Investigator or designee\]. The protocol and statistical analysis plan will be made available on Clinicaltrials.gov only as required by federal regulation or as a condition of awards and agreements supporting the research.