RecruitingNot ApplicableNCT06534918

Precise Oncology Interventions in Nutrition and Training (OnPoint)


Sponsor

University of Miami

Enrollment

306 participants

Start Date

Sep 18, 2024

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 18 Years

Inclusion Criteria12

  • 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
  • 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 Criteria12

  • 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

Interventions

OTHERFitbit

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.

BEHAVIORALNutrition 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.

BEHAVIORALPhysical 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.

BEHAVIORALNutrition 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.

BEHAVIORALPhysical 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

BEHAVIORALNutrition 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.


Locations(1)

University of Miami

Miami, Florida, United States

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NCT06534918


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