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

N/AActive Not RecruitingNCT05327452

Dana-Farber Cancer Institute135 enrolled

Overview

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.

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

Allocation

RANDOMIZED

Purpose

SUPPORTIVE_CARE

Masking

NONE

Enrollment

135

Conditions

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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.

Outcomes

Primary Outcomes

Change in Physical Activity Participation

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 Outcomes

Biomarkers for Cardiovascular and Metabolic Health - insulin

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

Blood Pressure

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

Body Composition

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

Cardiopulmonary Fitness

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

Physical Fitness

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

Cardiorespiratory Fitness

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

Muscular Strength

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

Patient Reported Outcomes - Quality of Life

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

Patient Reported Outcomes - Health-related domains

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

Patient Reported Outcomes - Sleep

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

Patient Reported Outcomes - Symptoms

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

Dietary Assessment

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

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.

Time frame: Evaluated at months 2 and 4

Feasibility of Intervention Questionnaire Ratings

Time frame: Evaluated at months 2 and 4

Augmentation Index

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

Biomarkers for Cardiovascular and Metabolic Health - glucose

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

Biomarkers for Cardiovascular and Metabolic Health - HbA1c

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.

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.

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

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.

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

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

Overview

Conditions

Interventions

Eligibility

Locations (2)

Outcomes

Primary Outcomes

Secondary Outcomes