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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05327452
Recruitment Status : Recruiting
First Posted : April 14, 2022
Last Update Posted : November 15, 2022
Sponsor:
Collaborators:
National Cancer Institute (NCI)
University of Massachusetts, Boston
Information provided by (Responsible Party):
Christina Dieli-Conwright, PhD, Dana-Farber Cancer Institute

Study Description
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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.

Condition or disease Intervention/treatment Phase
Breast Cancer Colorectal Cancer Prostate Cancer Behavioral: Supervised Home-Based Exercise Behavioral: Unsupervised Home-Based Exercise Behavioral: Attention Control Not Applicable

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.

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 135 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
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
Actual Study Start Date : October 31, 2022
Estimated Primary Completion Date : December 31, 2024
Estimated Study Completion Date : January 31, 2025

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: 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.

 Behavioral: Supervised Home-Based Exercise
Online supervised aerobic and resistance exercise
Experimental: 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.

 Behavioral: Unsupervised Home-Based Exercise
Unsupervised aerobic and resistance exercise (UNSUP)
Active Comparator: 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.

 Behavioral: Attention Control
Stretching Program


Outcome Measures
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Primary Outcome Measures :
  1. 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 ]
    Changes from baseline in physical activity participation measured by Godin Leisure-Time Exercise Questionnaire.


Secondary Outcome Measures :
  1. 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 ]
    Fasting blood will be drawn from the antecubital vein by a trained phlebotomist. Insulin will be measured.

  2. Blood Pressure [ Time Frame: Evaluated at week 1 for baseline, week 16 for post-intervention assessment, and week 32 for follow-up ]
    Blood pressure will be assessed using an automated blood pressure cuff to measure both systolic and diastolic blood pressure.

  3. Body Composition [ Time Frame: Evaluated at week 1 for baseline, week 16 for post-intervention assessment, and week 32 for follow-up ]
    Body composition (lean mass and fat mass) will be assessed via bioelectrical impedance using a validated scale.

  4. 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 ]
    Cardiopulmonary fitness will be measured by a submaximal graded exercise cycling test.

  5. Physical Fitness [ Time Frame: Evaluated at week 1 for baseline, week 16 for post-intervention assessment, and week 32 for follow-up ]
    Physical Fitness will be measured by the short physical performance battery (SPPB).

  6. Cardiorespiratory Fitness [ Time Frame: Evaluated at week 1 for baseline, week 16 for post-intervention assessment, and week 32 for follow-up ]
    Cardiorespiratory fitness will be assessed by the 6-minute walk test.

  7. 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 ]
    Muscular strength will be assessed with a 10 repetition maximum test.

  8. 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 ]
    Quality of life will be assessed by EORTC QLQ C-30.

  9. 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 ]
    Health-related domains of patient reported outcomes will be assessed by PROMIS-29 Profile v2.1.

  10. Patient Reported Outcomes - Sleep [ Time Frame: Evaluated at week 1 for baseline, week 16 for post-intervention assessment, and week 32 for follow-up ]
    Quality of life will be assessed by the Pittsburg Sleep Quality Index (PSQI).

  11. Patient Reported Outcomes - Symptoms [ Time Frame: Evaluated at week 1 for baseline, week 16 for post-intervention assessment, and week 32 for follow-up ]
    Symptomatic toxicities will be assessed by PRO-CTCAE.

  12. Dietary Assessment [ Time Frame: Evaluated at week 1 for baseline, week 16 for post-intervention assessment, and week 32 for follow-up ]
    Dietary recall will be used to assess recent dietary patterns for two weekdays and one weekend day using NutriBase 11.

  13. Acceptability of Intervention Questionnaire Ratings [ Time Frame: Evaluated at months 2 and 4 ]
    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.

  14. Feasibility of Intervention Questionnaire Ratings [ Time Frame: Evaluated at months 2 and 4 ]
    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.

  15. Augmentation Index [ Time Frame: Time Frame: Evaluated at week 1 for baseline, week 16 for post-intervention assessment, and week 32 for follow-up ]
    Augmentation index (a marker for arterial stiffness) will also be assessed using Mobil-O-Graph device.

  16. 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 ]
    Fasting blood will be drawn from the antecubital vein by a trained phlebotomist. Glucose will be measured.

  17. 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. ]
    Fasting blood will be drawn from the antecubital vein by a trained phlebotomist. HbA1c will be measured.

  18. 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. ]
    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.

  19. 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. ]
    Fasting blood will be drawn from the antecubital vein by a trained phlebotomist. C-reactive protein (CRP; biomarker of system inflammation) will be measured.


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05327452


Contacts
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Contact: Christina Dieli-Conwright, PhD, MPH 617-582-8321 ChristinaM_Dieli-Conwright@dfci.harvard.edu
Contact: Mary Norris, MSc 8572150195 maryk_norris@dfci.harvard.edu

Locations
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United States, Massachusetts
Brigham and Women's Hospital Recruiting
Boston, Massachusetts, United States, 02115
Contact: Christina Dieli-Conwright, PhD, MPH    617-582-8321    ChristinaM_Dieli-Conwright@DFCI.HARVARD.EDU   
Principal Investigator: Christina Dieli-Conwright, PhD, MPH         
Dana Farber Cancer Institute Recruiting
Boston, Massachusetts, United States, 02215
Contact: Christina Dieli-Conwright, PhD, MPH    617-632-3800    ChristinaM_Dieli-Conwright@dfci.harvard.edu   
Contact: PhD, MPH         
Principal Investigator: Christina Dieli-Conwright, PhD         
Sponsors and Collaborators
Dana-Farber Cancer Institute
National Cancer Institute (NCI)
University of Massachusetts, Boston
Investigators
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Principal Investigator: Christina Dieli-Conwright, PhD, MPH Dana-Farber Cancer Institute
More Information
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Responsible Party: Christina Dieli-Conwright, PhD, Principal Investigator, Dana-Farber Cancer Institute
ClinicalTrials.gov Identifier: NCT05327452    
Other Study ID Numbers: 21-559
2U54CA156732-11 ( U.S. NIH Grant/Contract )
First Posted: April 14, 2022    Key Record Dates
Last Update Posted: November 15, 2022
Last Verified: November 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: 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.
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Informed Consent Form (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

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Christina Dieli-Conwright, PhD, Dana-Farber Cancer Institute:
Breast Cancer
Colorectal Cancer
Prostate Cancer
Additional relevant MeSH terms:
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Prostatic Neoplasms
Colorectal Neoplasms
Neoplasms by Site
Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Genital Diseases, Male
Genital Diseases
Urogenital Diseases
Prostatic Diseases
 Male Urogenital Diseases
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases