Clinical trial NCT05327452: 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
Overall status: RECRUITING
Phase: NA
Conditions: Breast Cancer
Colorectal Cancer
Prostate Cancer
Keywords: Breast Cancer
Colorectal Cancer
Prostate Cancer
Lead sponsor: Dana-Farber Cancer Institute
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
name: University of Massachusetts, Boston
First posted: 2022-04-14
Enrollment: 135
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

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.

Primary outcomes:
measure: Change in Physical Activity Participation
timeFrame: Evaluated at week 1 for baseline, week 16 for post-intervention assessment, and week 32 for follow-up
Secondary outcomes:
measure: Biomarkers for Cardiovascular and Metabolic Health - insulin
timeFrame: Evaluated at week 1 for baseline, week 16 for post-intervention assessment, and week 32 for follow-up
measure: Blood Pressure
timeFrame: Evaluated at week 1 for baseline, week 16 for post-intervention assessment, and week 32 for follow-up
measure: Body Composition
timeFrame: Evaluated at week 1 for baseline, week 16 for post-intervention assessment, and week 32 for follow-up
measure: Cardiopulmonary Fitness
timeFrame: Evaluated at week 1 for baseline, week 9 for mid-point, week 16 for post-intervention assessment, and week 32 for follow-up
measure: Physical Fitness
timeFrame: Evaluated at week 1 for baseline, week 16 for post-intervention assessment, and week 32 for follow-up
measure: Cardiorespiratory Fitness
timeFrame: Evaluated at week 1 for baseline, week 16 for post-intervention assessment, and week 32 for follow-up
measure: Muscular Strength
timeFrame: Evaluated at week 1 for baseline, week 9 for mid-point, week 16 for post-intervention assessment, and week 32 for follow-up
measure: Patient Reported Outcomes - Quality of Life
timeFrame: Evaluated at week 1 for baseline, week 16 for post-intervention assessment, and week 32 for follow-up
measure: Patient Reported Outcomes - Health-related domains
timeFrame: Evaluated at week 1 for baseline, week 16 for post-intervention assessment, and week 32 for follow-up
measure: Patient Reported Outcomes - Sleep
timeFrame: Evaluated at week 1 for baseline, week 16 for post-intervention assessment, and week 32 for follow-up
measure: Patient Reported Outcomes - Symptoms
timeFrame: Evaluated at week 1 for baseline, week 16 for post-intervention assessment, and week 32 for follow-up
measure: Dietary Assessment
timeFrame: Evaluated at week 1 for baseline, week 16 for post-intervention assessment, and week 32 for follow-up
measure: Acceptability of Intervention Questionnaire Ratings
timeFrame: Evaluated at months 2 and 4
measure: Feasibility of Intervention Questionnaire Ratings
timeFrame: Evaluated at months 2 and 4
measure: Augmentation Index
timeFrame: Time Frame: Evaluated at week 1 for baseline, week 16 for post-intervention assessment, and week 32 for follow-up
measure: Biomarkers for Cardiovascular and Metabolic Health - glucose
timeFrame: Evaluated at week 1 for baseline, week 16 for post-intervention assessment, and week 32 for follow-up
measure: Biomarkers for Cardiovascular and Metabolic Health - HbA1c
timeFrame: Evaluated at week 1 for baseline, week 16 for post-intervention assessment, and week 32 for follow-up.
measure: Biomarkers for Cardiovascular and Metabolic Health - c-peptide
timeFrame: Evaluated at week 1 for baseline, week 16 for post-intervention assessment, and week 32 for follow-up.
measure: Biomarkers for Cardiovascular and Metabolic Health - c-reactive protein
timeFrame: Evaluated at week 1 for baseline, week 16 for post-intervention assessment, and week 32 for follow-up.
Other outcomes:
Locations:
city: Boston
country: United States
facility: Brigham and Women's Hospital
state: Massachusetts
city: Boston
country: United States
facility: Dana Farber Cancer Institute
state: Massachusetts
Study officials:
affiliation: Dana-Farber Cancer Institute
name: Christina Dieli-Conwright, PhD, MPH
role: PRINCIPAL_INVESTIGATOR
References: