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

Primary Purpose

Breast Cancer, Colorectal Cancer, Prostate Cancer

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Supervised Home-Based Exercise
Unsupervised Home-Based Exercise
Attention Control
Sponsored by
Dana-Farber Cancer Institute
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Breast Cancer focused on measuring Breast Cancer, Colorectal Cancer, Prostate Cancer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Brigham and Women's HospitalRecruiting
  • Dana Farber Cancer InstituteRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Active Comparator

Arm Label

Supervised aerobic and resistance exercise (SUP)

Unsupervised aerobic and resistance exercise (UNSUP)

Attention Control (AC)

Arm Description

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.

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.

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.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Biomarkers for Cardiovascular and Metabolic Health - insulin
Fasting blood will be drawn from the antecubital vein by a trained phlebotomist. Insulin will be measured.
Blood Pressure
Blood pressure will be assessed using an automated blood pressure cuff to measure both systolic and diastolic blood pressure.
Body Composition
Body composition (lean mass and fat mass) will be assessed via bioelectrical impedance using a validated scale.
Cardiopulmonary Fitness
Cardiopulmonary fitness will be measured by a submaximal graded exercise cycling test.
Physical Fitness
Physical Fitness will be measured by the short physical performance battery (SPPB).
Cardiorespiratory Fitness
Cardiorespiratory fitness will be assessed by the 6-minute walk test.
Muscular Strength
Muscular strength will be assessed with a 10 repetition maximum test.
Patient Reported Outcomes - Quality of Life
Quality of life will be assessed by EORTC QLQ C-30.
Patient Reported Outcomes - Health-related domains
Health-related domains of patient reported outcomes will be assessed by PROMIS-29 Profile v2.1.
Patient Reported Outcomes - Sleep
Quality of life will be assessed by the Pittsburg Sleep Quality Index (PSQI).
Patient Reported Outcomes - Symptoms
Symptomatic toxicities will be assessed by PRO-CTCAE.
Dietary Assessment
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
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
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
Augmentation index (a marker for arterial stiffness) will also be assessed using Mobil-O-Graph device.
Biomarkers for Cardiovascular and Metabolic Health - glucose
Fasting blood will be drawn from the antecubital vein by a trained phlebotomist. Glucose will be measured.
Biomarkers for Cardiovascular and Metabolic Health - HbA1c
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
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
Fasting blood will be drawn from the antecubital vein by a trained phlebotomist. C-reactive protein (CRP; biomarker of system inflammation) will be measured.

Full Information

First Posted
March 11, 2022
Last Updated
November 14, 2022
Sponsor
Dana-Farber Cancer Institute
Collaborators
National Cancer Institute (NCI), University of Massachusetts, Boston
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1. Study Identification

Unique Protocol Identification Number
NCT05327452
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
Study Type
Interventional

2. Study Status

Record Verification Date
November 2022
Overall Recruitment Status
Recruiting
Study Start Date
October 31, 2022 (Actual)
Primary Completion Date
December 31, 2024 (Anticipated)
Study Completion Date
January 31, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Dana-Farber Cancer Institute
Collaborators
National Cancer Institute (NCI), University of Massachusetts, Boston

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Breast Cancer, Colorectal Cancer, Prostate Cancer
Keywords
Breast Cancer, Colorectal Cancer, Prostate Cancer

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
135 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Supervised aerobic and resistance exercise (SUP)
Arm Type
Experimental
Arm Description
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.
Arm Title
Unsupervised aerobic and resistance exercise (UNSUP)
Arm Type
Experimental
Arm Description
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.
Arm Title
Attention Control (AC)
Arm Type
Active Comparator
Arm Description
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 Type
Behavioral
Intervention Name(s)
Supervised Home-Based Exercise
Intervention Description
Online supervised aerobic and resistance exercise
Intervention Type
Behavioral
Intervention Name(s)
Unsupervised Home-Based Exercise
Intervention Description
Unsupervised aerobic and resistance exercise (UNSUP)
Intervention Type
Behavioral
Intervention Name(s)
Attention Control
Intervention Description
Stretching Program
Primary Outcome Measure Information:
Title
Change in Physical Activity Participation
Description
Changes from baseline in physical activity participation measured by Godin Leisure-Time Exercise Questionnaire.
Time Frame
Evaluated at week 1 for baseline, week 16 for post-intervention assessment, and week 32 for follow-up
Secondary Outcome Measure Information:
Title
Biomarkers for Cardiovascular and Metabolic Health - insulin
Description
Fasting blood will be drawn from the antecubital vein by a trained phlebotomist. Insulin will be measured.
Time Frame
Evaluated at week 1 for baseline, week 16 for post-intervention assessment, and week 32 for follow-up
Title
Blood Pressure
Description
Blood pressure will be assessed using an automated blood pressure cuff to measure both systolic and diastolic blood pressure.
Time Frame
Evaluated at week 1 for baseline, week 16 for post-intervention assessment, and week 32 for follow-up
Title
Body Composition
Description
Body composition (lean mass and fat mass) will be assessed via bioelectrical impedance using a validated scale.
Time Frame
Evaluated at week 1 for baseline, week 16 for post-intervention assessment, and week 32 for follow-up
Title
Cardiopulmonary Fitness
Description
Cardiopulmonary fitness will be measured by a submaximal graded exercise cycling test.
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
Title
Physical Fitness
Description
Physical Fitness will be measured by the short physical performance battery (SPPB).
Time Frame
Evaluated at week 1 for baseline, week 16 for post-intervention assessment, and week 32 for follow-up
Title
Cardiorespiratory Fitness
Description
Cardiorespiratory fitness will be assessed by the 6-minute walk test.
Time Frame
Evaluated at week 1 for baseline, week 16 for post-intervention assessment, and week 32 for follow-up
Title
Muscular Strength
Description
Muscular strength will be assessed with a 10 repetition maximum test.
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
Title
Patient Reported Outcomes - Quality of Life
Description
Quality of life will be assessed by EORTC QLQ C-30.
Time Frame
Evaluated at week 1 for baseline, week 16 for post-intervention assessment, and week 32 for follow-up
Title
Patient Reported Outcomes - Health-related domains
Description
Health-related domains of patient reported outcomes will be assessed by PROMIS-29 Profile v2.1.
Time Frame
Evaluated at week 1 for baseline, week 16 for post-intervention assessment, and week 32 for follow-up
Title
Patient Reported Outcomes - Sleep
Description
Quality of life will be assessed by the Pittsburg Sleep Quality Index (PSQI).
Time Frame
Evaluated at week 1 for baseline, week 16 for post-intervention assessment, and week 32 for follow-up
Title
Patient Reported Outcomes - Symptoms
Description
Symptomatic toxicities will be assessed by PRO-CTCAE.
Time Frame
Evaluated at week 1 for baseline, week 16 for post-intervention assessment, and week 32 for follow-up
Title
Dietary Assessment
Description
Dietary recall will be used to assess recent dietary patterns for two weekdays and one weekend day using NutriBase 11.
Time Frame
Evaluated at week 1 for baseline, week 16 for post-intervention assessment, and week 32 for follow-up
Title
Acceptability of Intervention Questionnaire Ratings
Description
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.
Time Frame
Evaluated at months 2 and 4
Title
Feasibility of Intervention Questionnaire Ratings
Description
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.
Time Frame
Evaluated at months 2 and 4
Title
Augmentation Index
Description
Augmentation index (a marker for arterial stiffness) will also be assessed using Mobil-O-Graph device.
Time Frame
Time Frame: Evaluated at week 1 for baseline, week 16 for post-intervention assessment, and week 32 for follow-up
Title
Biomarkers for Cardiovascular and Metabolic Health - glucose
Description
Fasting blood will be drawn from the antecubital vein by a trained phlebotomist. Glucose will be measured.
Time Frame
Evaluated at week 1 for baseline, week 16 for post-intervention assessment, and week 32 for follow-up
Title
Biomarkers for Cardiovascular and Metabolic Health - HbA1c
Description
Fasting blood will be drawn from the antecubital vein by a trained phlebotomist. HbA1c will be measured.
Time Frame
Evaluated at week 1 for baseline, week 16 for post-intervention assessment, and week 32 for follow-up.
Title
Biomarkers for Cardiovascular and Metabolic Health - c-peptide
Description
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.
Time Frame
Evaluated at week 1 for baseline, week 16 for post-intervention assessment, and week 32 for follow-up.
Title
Biomarkers for Cardiovascular and Metabolic Health - c-reactive protein
Description
Fasting blood will be drawn from the antecubital vein by a trained phlebotomist. C-reactive protein (CRP; biomarker of system inflammation) will be measured.
Time Frame
Evaluated at week 1 for baseline, week 16 for post-intervention assessment, and week 32 for follow-up.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Christina Dieli-Conwright, PhD, MPH
Phone
617-582-8321
Email
ChristinaM_Dieli-Conwright@dfci.harvard.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Mary Norris, MSc
Phone
8572150195
Email
maryk_norris@dfci.harvard.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Christina Dieli-Conwright, PhD, MPH
Organizational Affiliation
Dana-Farber Cancer Institute
Official's Role
Principal Investigator
Facility Information:
Facility Name
Brigham and Women's Hospital
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02115
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Christina Dieli-Conwright, PhD, MPH
Phone
617-582-8321
Email
ChristinaM_Dieli-Conwright@DFCI.HARVARD.EDU
First Name & Middle Initial & Last Name & Degree
Christina Dieli-Conwright, PhD, MPH
Facility Name
Dana Farber Cancer Institute
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02215
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Christina Dieli-Conwright, PhD, MPH
Phone
617-632-3800
Email
ChristinaM_Dieli-Conwright@dfci.harvard.edu
First Name & Middle Initial & Last Name & Degree
PhD, MPH
First Name & Middle Initial & Last Name & Degree
Christina Dieli-Conwright, PhD

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing 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.
IPD Sharing Time Frame
Data can be shared no earlier than 1 year following the date of publication
IPD Sharing Access Criteria
Contact the Belfer Office for Dana-Farber Innovations (BODFI) at innovation@dfci.harvard.edu

Learn more about this trial

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

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