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NCT Number: NCT06534918

Precise Oncology Interventions in Nutrition and Training (OnPoint)

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.

Recruiting

Interested in participating?

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Key information

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Inclusion criteria

- Healthcare Providers

  • 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
  • Blank
  • 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

Treatment and study plan

FitBit

Other

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

Behavioral

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

Behavioral

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

Behavioral

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

Behavioral

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

Behavioral

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 outcomes

  1. 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%.

  2. Percentage of Interventions Sessions Completed

    Time frame: Up to 8 Weeks

    Percentage of intervention sessions completed will be reported as ≥ 80%.

  3. 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Grey Freylersythe, BS

CONTACT

[email protected]

305-243-9832

Tracy Crane, PhD, RDN

CONTACT

[email protected]

305-243-8255

Sponsors and collaborators

Lead sponsor

University of Miami

Other

Collaborators

  • The Applebaum Foundation

Registry information

Acronym: OnPoint

Important dates

Study start
2024
Primary completion
2027
Study completion
2027
First posted
Aug 2, 2024
Registry last updated
Sep 19, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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