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Breast CancerNCT05327452

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

A study testing Supervised Home-Based Exercise and Unsupervised Home-Based Exercise in people with Breast Cancer and Colorectal Cancer, run by Dana-Farber Cancer Institute at 2 sites in United States.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Breast Cancer, Colorectal Cancer, Prostate Cancer
What is being tested?
Supervised Home-Based Exercise and Unsupervised Home-Based Exercise
Could I receive a placebo?
No, everyone receives an active treatment
How many people
135 participants
Where
2 sitesUnited States
Study dates
31 Oct 2022to 31 May 2027
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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
Show all 10Show fewer
  • 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.

Who cannot join

  • 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.

Trial locations and contacts

2 sites in 1 country.

United States2 sites

  • Brigham and Women's Hospital

    Boston, Massachusetts, 02115

  • Dana Farber Cancer Institute

    Boston, Massachusetts, 02215

Other trials in United States

About this study

Official title: Testing Home-based Exercise Strategies to Improve Exercise Participation and Cardiovascular Health in Underserved Minority Patients With Cancer Undergoing Chemotherapy: the THRIVE Study

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.
Read the 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.

Being tested
Supervised Home-Based Exercise, Unsupervised Home-Based Exercise, Attention Control
Keywords
Breast Cancer, Colorectal Cancer, Prostate Cancer
Medical subject headings
Breast Neoplasms, Colorectal Neoplasms, Prostatic Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Supervised Home-Based ExerciseBehavioural

    Online supervised aerobic and resistance exercise

  • Unsupervised Home-Based ExerciseBehavioural

    Unsupervised aerobic and resistance exercise (UNSUP)

  • Attention ControlBehavioural

    Stretching Program

Study groups in NCT05327452
Study groupRoleWhat they receive
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.
Receives: Behavioral: Supervised Home-Based Exercise
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.
Receives: Behavioral: Unsupervised Home-Based Exercise
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.
Receives: Behavioral: Attention Control

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change in Physical Activity Participation

    Changes from baseline in physical activity participation measured by Godin Leisure-Time Exercise Questionnaire.

    Measured: Evaluated at week 1 for baseline, week 16 for post-intervention assessment, and week 32 for follow-up

Secondary outcomes (19)

  1. Biomarkers for Cardiovascular and Metabolic Health - insulin

    Fasting blood will be drawn from the antecubital vein by a trained phlebotomist. Insulin will be measured.

    Measured: Evaluated at week 1 for baseline, week 16 for post-intervention assessment, and week 32 for follow-up

  2. Blood Pressure

    Blood pressure will be assessed using an automated blood pressure cuff to measure both systolic and diastolic blood pressure.

    Measured: Evaluated at week 1 for baseline, week 16 for post-intervention assessment, and week 32 for follow-up

  3. Body Composition

    Body composition (lean mass and fat mass) will be assessed via bioelectrical impedance using a validated scale.

    Measured: Evaluated at week 1 for baseline, week 16 for post-intervention assessment, and week 32 for follow-up

  4. Cardiopulmonary Fitness

    Cardiopulmonary fitness will be measured by a submaximal graded exercise cycling test.

    Measured: Evaluated at week 1 for baseline, week 9 for mid-point, week 16 for post-intervention assessment, and week 32 for follow-up

  5. Physical Fitness

    Physical Fitness will be measured by the short physical performance battery (SPPB).

    Measured: Evaluated at week 1 for baseline, week 16 for post-intervention assessment, and week 32 for follow-up

  6. Cardiorespiratory Fitness

    Cardiorespiratory fitness will be assessed by the 6-minute walk test.

    Measured: Evaluated at week 1 for baseline, week 16 for post-intervention assessment, and week 32 for follow-up

  7. Muscular Strength

    Muscular strength will be assessed with a 10 repetition maximum test.

    Measured: Evaluated at week 1 for baseline, week 9 for mid-point, week 16 for post-intervention assessment, and week 32 for follow-up

  8. Patient Reported Outcomes - Quality of Life

    Quality of life will be assessed by EORTC QLQ C-30.

    Measured: Evaluated at week 1 for baseline, week 16 for post-intervention assessment, and week 32 for follow-up

  9. Patient Reported Outcomes - Health-related domains

    Health-related domains of patient reported outcomes will be assessed by PROMIS-29 Profile v2.1.

    Measured: Evaluated at week 1 for baseline, week 16 for post-intervention assessment, and week 32 for follow-up

  10. Patient Reported Outcomes - Sleep

    Quality of life will be assessed by the Pittsburg Sleep Quality Index (PSQI).

    Measured: Evaluated at week 1 for baseline, week 16 for post-intervention assessment, and week 32 for follow-up

  11. Patient Reported Outcomes - Symptoms

    Symptomatic toxicities will be assessed by PRO-CTCAE.

    Measured: Evaluated at week 1 for baseline, week 16 for post-intervention assessment, and week 32 for follow-up

  12. Dietary Assessment

    Dietary recall will be used to assess recent dietary patterns for two weekdays and one weekend day using NutriBase 11.

    Measured: Evaluated at week 1 for baseline, week 16 for post-intervention assessment, and week 32 for follow-up

  13. Acceptability of Intervention Questionnaire Ratings

    Intervention acceptability and feasibility will be assessed via Acceptability of Intervention and Feasibility of Intervention questionnaires. Items are measured on a 5-point Likert scale (completely disagree to completely agree). Score is calculated mean. An average rating of 4 or higher will be considered feasible/acceptable.

    Measured: Evaluated at months 2 and 4

  14. Feasibility of Intervention Questionnaire Ratings

    Intervention acceptability and feasibility will be assessed via Acceptability of Intervention and Feasibility of Intervention questionnaires. Items are measured on a 5-point Likert scale (completely disagree to completely agree). Score is calculated mean. An average rating of 4 or higher will be considered feasible/acceptable.

    Measured: Evaluated at months 2 and 4

  15. Augmentation Index

    Augmentation index (a marker for arterial stiffness) will also be assessed using Mobil-O-Graph device.

    Measured: Time Frame: Evaluated at week 1 for baseline, week 16 for post-intervention assessment, and week 32 for follow-up

  16. Biomarkers for Cardiovascular and Metabolic Health - glucose

    Fasting blood will be drawn from the antecubital vein by a trained phlebotomist. Glucose will be measured.

    Measured: Evaluated at week 1 for baseline, week 16 for post-intervention assessment, and week 32 for follow-up

  17. Biomarkers for Cardiovascular and Metabolic Health - HbA1c

    Fasting blood will be drawn from the antecubital vein by a trained phlebotomist. HbA1c will be measured.

    Measured: Evaluated at week 1 for baseline, week 16 for post-intervention assessment, and week 32 for follow-up.

  18. Biomarkers for Cardiovascular and Metabolic Health - c-peptide

    Fasting blood will be drawn from the antecubital vein by a trained phlebotomist. C-peptide (biomarkers of glycemic control and insulin resistance) will be measured.

    Measured: Evaluated at week 1 for baseline, week 16 for post-intervention assessment, and week 32 for follow-up.

  19. Biomarkers for Cardiovascular and Metabolic Health - c-reactive protein

    Fasting blood will be drawn from the antecubital vein by a trained phlebotomist. C-reactive protein (CRP; biomarker of system inflammation) will be measured.

    Measured: Evaluated at week 1 for baseline, week 16 for post-intervention assessment, and week 32 for follow-up.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted14 Apr 2022
  2. Study start31 Oct 2022
  3. Primary completion31 Dec 2026 (estimated)
  4. Study completion31 May 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Supportive care
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
135 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05327452
Sponsor's protocol ID
21-559
Other IDs
2U54CA156732-11
Status last verified
Jan 2026
First submitted
11 Mar 2022
Last updated
21 Jan 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: 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.

Publications

  • 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.

    PubMed 39351353

Questions about this trial

What is this clinical trial studying?

A study testing Supervised Home-Based Exercise and Unsupervised Home-Based Exercise in people with Breast Cancer and Colorectal Cancer, run by Dana-Farber Cancer Institute at 2 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 10 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 21 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05327452, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Jan 2026.

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