Precise Oncology Interventions in Nutrition and Training (OnPoint)

Part of paid clinical trials in Miami, Florida.

Sponsor
University of Miami
Study ID
NCT06534918
Status
Recruiting
Apply to this trial

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Accepted

Interventions

  • 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.

Study Details

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.

Key Dates

Start date
Sep 18, 2024
Status verified
Sep 2025
Primary completion
Sep 30, 2027
Completion
Sep 30, 2027

Study Design

Enrollment
306 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE

Arms

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

Primary Outcome Measure

Percentage of Survivors Who Agree to Participate [ Time Frame: Up to 8 Weeks ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
University of MiamiMiamiFlorida33136
Grey Freylersythe, BS
[email protected]
305-243-9832
Tracy Crane, PhD, RDN
[email protected]
(305) 243-8255
Tracy Crane, PhD, RDN (PRINCIPAL_INVESTIGATOR)

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Breast cancerColorectal cancerProstate cancer
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OncologyBreast oncologyWomen's healthGI oncologyProstate oncologyMen's healthUrology
By research site
University of Miami· Miami, FL

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