Precise Oncology Interventions in Nutrition and Training (OnPoint)

Overview

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 Interventions Sessions Completed [Time frame: Up to 8 Weeks]
• Percentage of Participants Satisfied with the Intervention [Time frame: Up to 8 Weeks]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Single blind

Primary purpose

Supportive care

Study locations

United States · 1 center

• University of Miami — Miami

Identifiers

NCT: NCT06534918 · 20230533

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗