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

• ClinicalTrials.gov Identifier: NCT05327452
• Recruitment Status: Recruiting
• First Posted: April 14, 2022
• Last Update Posted: November 22, 2023
• Sponsor: Dana-Farber Cancer Institute
• Collaborators: National Cancer Institute (NCI); University of Massachusetts, Boston
• Information provided by (Responsible Party): Christina Dieli-Conwright, PhD, Dana-Farber Cancer Institute

Tracking Information

• First Submitted Date: March 11, 2022
• First Posted Date: April 14, 2022
• Last Update Posted Date: November 22, 2023
• Actual Study Start Date: October 31, 2022
• Estimated Primary Completion Date: December 31, 2024 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: April 11, 2022)

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.

• Original Primary Outcome Measures: Same as current

Current Secondary Outcome Measures (submitted: April 11, 2022)

• 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.
• 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.
• 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.
• 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.
• 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).
• 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.
• 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.
• 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.
• 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.
• 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).
• 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.
• 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.
• 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.
• 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.
• 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.
• 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.
• 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.
• 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.
• 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.

• Original Secondary Outcome Measures: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

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

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.

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 Type: Interventional
• Study Phase: Not Applicable
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: None (Open Label); Primary Purpose: Supportive Care

Condition

• Breast Cancer
• Colorectal Cancer
• Prostate Cancer

Intervention

• Behavioral: Supervised Home-Based Exercise
  Online supervised aerobic and resistance exercise
• Behavioral: Unsupervised Home-Based Exercise
  Unsupervised aerobic and resistance exercise (UNSUP)
• Behavioral: Attention Control
  Stretching Program

Study Arms

• 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.

  Intervention: Behavioral: Supervised Home-Based 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.

  Intervention: Behavioral: Unsupervised Home-Based Exercise
• 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.

  Intervention: Behavioral: Attention Control

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Recruiting
• Estimated Enrollment (submitted: April 11, 2022): 135
• Original Estimated Enrollment: Same as current
• Estimated Study Completion Date: January 31, 2025
• Estimated Primary Completion Date: December 31, 2024 (Final data collection date for primary outcome measure)

Eligibility 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.

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Contacts

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

• Listed Location Countries: United States

Administrative Information

• NCT Number: NCT05327452
• Other Study ID Numbers: 21-559; 2U54CA156732-11 ( U.S. NIH Grant/Contract )
• Has Data Monitoring Committee: No

U.S. FDA-regulated Product

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

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
• Supporting Materials: Statistical Analysis Plan (SAP)
• Supporting Materials: 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

• Current Responsible Party: Christina Dieli-Conwright, PhD, Dana-Farber Cancer Institute
• Original Responsible Party: Same as current
• Current Study Sponsor: Dana-Farber Cancer Institute
• Original Study Sponsor: Same as current

Collaborators

• National Cancer Institute (NCI)
• University of Massachusetts, Boston

Investigators

• Principal Investigator: Christina Dieli-Conwright, PhD, MPH; Dana-Farber Cancer Institute

• PRS Account: Dana-Farber Cancer Institute
• Verification Date: November 2023