Precise Oncology Interventions in Nutrition and Training (OnPoint)
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity of Miami
About this trial
The purpose of this study is to see if survivors of breast, prostate, colorectal or lymphoma 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 criteria
This trial accepts healthy volunteersQualifiers
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
18 years of age or older
Disqualifiers
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
Trial design
Design model
Parallel
Treatments tested in this trial
Fitbit
Other interventionParticipants 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
BehavioralThe 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
BehavioralThe 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
BehavioralParticipants 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
BehavioralParticipants 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
BehavioralParticipants 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.
Treatment groups
306 Participants
are divided into 4 treatment groupsGroup A: Low Complexity GroupExperimental treatment 2 interventions
Group B: Moderate Complexity GroupExperimental treatment 4 interventions
Group C: High Complexity GroupExperimental treatment 4 interventions
Group D: Control GroupNo intervention 0 interventions
Trial outcomes
Primary outcomes
1
Percentage of Survivors Who Agree to Participate
Percentage of survivors who agree to participate will be reported as ≥ 50%.
Time frame
Up to 8 Weeks2
Percentage of Interventions Sessions Completed
Percentage of intervention sessions completed will be reported as ≥ 80%.
Time frame
Up to 8 Weeks3
Percentage of Participants Satisfied with the Intervention
Report of 80% satisfaction will be determined as satisfaction with intervention components.
Time frame
Up to 8 WeeksSponsors and contacts
Click on the lead sponsor to view all of their trials.
University of Miami
Lead sponsor
The Applebaum Foundation
Collaborator
Source ClinicalTrials.gov