NCT06534918 · University of Miami
Precise Oncology Interventions in Nutrition and Training (OnPoint)
(OnPoint)
What this study is about
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.
View original scientific description
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.
Interventions
OTHER
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.
BEHAVIORAL
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.
BEHAVIORAL
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.
BEHAVIORAL
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.
BEHAVIORAL
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
BEHAVIORAL
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 measures
Percentage of Survivors Who Agree to Participate
Time frame: Up to 8 Weeks
Percentage of survivors who agree to participate will be reported as ≥ 50%.
Percentage of Interventions Sessions Completed
Time frame: Up to 8 Weeks
Percentage of intervention sessions completed will be reported as ≥ 80%.
Percentage of Participants Satisfied with the Intervention
Time frame: Up to 8 Weeks
Report of 80% satisfaction will be determined as satisfaction with intervention components.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- Provide full- or part-time care in an oncology clinical care setting at Sylvester Comprehensive Cancer Center
- Utilize the electronic medical record for patient documentation on a regular basis
- Willing to complete a 30-60-minute interview Inclusion Criteria - Patients
- 18 years of age or older
- Any sex/gender
- Able to provide consent
- Able to read/understand English or Spanish
- Diagnosis of breast, prostate or colorectal cancer, 6 months post completion of primary treatment, with no evidence of primary disease
- Approval from treating oncologist, confirmed via email or in writing
- 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.
- Internet access on a smart phone, tablet, or computer
- Agree to be randomly assigned to any study group
Exclusion criteria
- Less than 18 years of age
- Unable to provide consent
- Unable to read/understand English or Spanish
- Any contraindication for diet change or exercising as determined by physician
- Engaging in \>150 minutes of moderate to vigorous physical activity on average per week for the prior month
- 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
- History of dementia or major psychiatric disease which would interfere with study participation
- History of recent (≤1 yr) stroke, myocardial infarction or congestive heart failure
- Eastern Cooperative Oncology Group (ECOG) score of \>2
- Severe lymphedema as determined by physician
- Receiving physical therapy treatment
Where
- Miami, Florida
Collaborators
The Applebaum Foundation
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Sep 19, 2025 · Source of record for eligibility and locations