Precise Oncology Interventions in Nutrition and Training (OnPoint) (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.

Study Overview

• Status: Recruiting
• Conditions: Breast Cancer; Colorectal Cancer; Prostate Cancer
• Intervention / Treatment: Other: Fitbit; Behavioral: Nutrition and Physical Activity Prescription; Behavioral: Nutrition Course: Group Sessions; Behavioral: Physical Activity Program: Group Sessions; Behavioral: Nutrition Course: One on One Sessions with Registered Dietitian; Behavioral: Physical Activity Program: One on One Sessions with an Exercise Physiologist

• Study Type: Interventional
• Enrollment (Estimated): 306
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Grey Freylersythe, BS; Phone Number: 305-243-9832; Email: g.freylersythe@med.miami.edu
• Study Contact Backup: Name: Tracy Crane, PhD, RDN; Phone Number: 305-243-8255; Email: tecrane@med.miami.edu

Study Locations

• United States
  • Florida
    • Miami, Florida, United States, 33136
      • Recruiting
      • University of Miami
      • Contact: Grey Freylersythe, BS; Phone Number: 305-243-9832; Email: g.freylersythe@med.miami.edu
      • Contact: Tracy Crane, PhD, RDN; Phone Number: (305) 243-8255; Email: tecrane@med.miami.edu
      • Principal Investigator: Tracy Crane, PhD, RDN

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Low Complexity Group; Participants in this group will receive the low complexity intervention for up to eight (8) weeks.	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 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.
Experimental: Moderate Complexity Group; Participants in this group will receive the moderate complexity intervention for up to eight (8) weeks.	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 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.; 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.
Experimental: High Complexity Group; Participants in this group will receive the high complexity intervention for up to eight (8) weeks.	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 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.; 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
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage of Survivors Who Agree to Participate	Percentage of survivors who agree to participate will be reported as ≥ 50%.	Up to 8 Weeks
Percentage of Interventions Sessions Completed	Percentage of intervention sessions completed will be reported as ≥ 80%.	Up to 8 Weeks
Percentage of Participants Satisfied with the Intervention	Report of 80% satisfaction will be determined as satisfaction with intervention components.	Up to 8 Weeks

Collaborators and Investigators

• Sponsor: University of Miami
• Collaborators: The Applebaum Foundation
• Investigators: Principal Investigator: Tracy Crane, PhD, RDN, University of Miami

Study record dates

Study Major Dates

• Study Start (Actual): September 18, 2024
• Primary Completion (Estimated): September 30, 2027
• Study Completion (Estimated): September 30, 2027

Study Registration Dates

• First Submitted: July 30, 2024
• First Submitted That Met QC Criteria: July 30, 2024
• First Posted (Actual): August 2, 2024

Study Record Updates

• Last Update Posted (Estimated): September 19, 2025
• Last Update Submitted That Met QC Criteria: September 15, 2025
• Last Verified: September 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Urogenital Diseases; Genital Diseases; Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Prostatic Diseases; Male Urogenital Diseases; Intestinal Diseases; Gastrointestinal Neoplasms; Digestive System Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Intestinal Neoplasms; Rectal Diseases; Colonic Diseases; Skin Diseases; Breast Diseases; Skin and Connective Tissue Diseases; Prostatic Neoplasms; Colorectal Neoplasms; Breast Neoplasms; Diet, Food, and Nutrition; Physiological Phenomena; Nutritional Physiological Phenomena; Population Characteristics; Health Status; Demography; Nutritional Status
• Other Study ID Numbers: 20230533

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No