Recruiting

Nutrition & Exercise

Sponsor:

University of Miami

Code:

NCT06534918

Conditions

Breast Cancer

Prostate Cancer

Colorectal Cancer

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Accepted

Interventions

Fitbit

Nutrition Course: Group Sessions

Physical Activity Program: Group Sessions

Nutrition Course: One on One Sessions with Registered Dietitian

Physical Activity Program: One on One Sessions with an Exercise Physiologist

Study Details

Brief summary:

The purpose of this study is to see if survivors of breast, prostate, or colorectal cancer who receive a personal referral to a targeted nutrition and exercise program will be able to eat a healthier diet and be more physically activity.

Conditions

Breast Cancer

Prostate Cancer

Colorectal Cancer

Study ID

NCT06534918

Start date

Sep 18, 2024

Status verified date

Sep, 2025

Completion date

Sep 30, 2027

Anticipated

Primary completion date

Sep 30, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Accepted

Inclusion Criteria:

Inclusion Criteria - Healthcare Providers

1. Provide full- or part-time care in an oncology clinical care setting at Sylvester Comprehensive Cancer Center
2. Utilize the electronic medical record for patient documentation on a regular basis
3. Willing to complete a 30-60-minute interview

Inclusion Criteria - Patients

1. 18 years of age or older
2. Any sex/gender
3. Able to provide consent
4. Able to read/understand English or Spanish
5. Diagnosis of breast, prostate or colorectal cancer, 6 months post completion of primary treatment, with no evidence of primary disease
6. Approval from treating oncologist, confirmed via email or in writing
7. Fail to meet at least one of the American Cancer Society guidelines: engaging in >150 minutes of moderate-to-vigorous physical activity per week for the prior month or consuming at least 3 cups of vegetables and 2 cups of fruit per day over the past month.
8. Internet access on a smart phone, tablet, or computer
9. Agree to be randomly assigned to any study group

Exclusion Criteria:

1. Less than 18 years of age
2. Unable to provide consent
3. Unable to read/understand English or Spanish
4. Any contraindication for diet change or exercising as determined by physician
5. Blank
6. Engaging in >150 minutes of moderate to vigorous physical activity on average per week for the prior month
7. Meeting the American Cancer Society diet recommendations (3 cups of vegetables or legumes, 2 cups of fruit, 2 serving whole grain per day, and limited red/processed meats, sugar-sweetened beverages, and highly processed foods) for the prior month
8. History of dementia or major psychiatric disease which would interfere with study participation
9. History of recent (≤1 yr) stroke, myocardial infarction or congestive heart failure
10. Eastern Cooperative Oncology Group (ECOG) score of >2
11. Severe lymphedema as determined by physician
12. Receiving physical therapy treatment

Study Design

Enrollment

306 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Supportive Care

Interventions and Outcome Measures

Arms

experimental: Low Complexity Group

Participants in this group will receive the low complexity intervention for up to eight (8) weeks.

experimental: Moderate Complexity Group

Participants in this group will receive the moderate complexity intervention for up to eight (8) weeks.

experimental: High Complexity Group

Participants in this group will receive the high complexity intervention for up to eight (8) weeks.

no intervention: Control Group

Participants randomized to this arm will receive routine care and will not receive any study materials until the end of the study at 24 weeks.

Interventions

Fitbit

Participants will be provided with a Fitbit. Self-reported physical activity, location, vital sign and sleep stage information will be collected and monitored every day for up to eight (8) weeks. Data will be synced to the My Wellness Research Software Platform, resulting in a weekly text or phone call check-in, based on participants preference.

Nutrition Course: Group Sessions

The nutrition course will follow a combined asynchronous and synchronous approach. The asynchronous component will consist of a pre-recorded session covering educational nutrition content, which will be made available to participants for self-paced learning. This will be followed by a synchronous, 30-60 minute live group education class on nutrition information for cancer survivors, held once per week.

Physical Activity Program: Group Sessions

The Physical Activity Program will be held virtually or in-person. This will be a 1-hour biweekly group education class on aerobic and resistance exercise recommendations for cancer survivors.

Nutrition Course: One on One Sessions with Registered Dietitian

Participants will be referred to weekly one on one nutrition counseling sessions with a Registered Dietitian. The one on one sessions are anticipated to last 30-60 minutes, based on the needs of the individual.

Physical Activity Program: One on One Sessions with an Exercise Physiologist

Participants will be referred to weekly one on one exercise training sessions with an Exercise Physiologist. The one on one sessions are anticipated to last 30-60 minutes, based on the needs of the individual

Nutrition and Physical Activity Prescription

Participants will receive a lifestyle medicine prescription pad, developed by the investigators, which serves as a checklist to assist participants in effectively monitoring their dietary habits and physical activity routines. Participants will also receive an 8-week text messages program which will direct participants to a webpage with nutrition and physical activity content.

Primary outcome measure

  • Percentage of Survivors Who Agree to Participate [ Time Frame: Up to 8 Weeks ]
  • Percentage of Interventions Sessions Completed [ Time Frame: Up to 8 Weeks ]
  • Percentage of Participants Satisfied with the Intervention [ Time Frame: Up to 8 Weeks ]

Central Contacts and Locations

Central contacts

Locations

University of Miami

Recruiting

Miami, Florida, United States, 33136

Contacts

Principal Investigator:

Tracy Crane, PhD, RDN

More Information

Sponsor

University of Miami

Last update posted

Sep 19, 2025

Last verified

Sep, 2025

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by University of Miami on 2025-09-19.