Precise Oncology Interventions in Nutrition and Training (OnPoint)
Conditions
Breast Cancer, Prostate Cancer, Colorectal CancerSummary
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.
Locations
1 location Found with status Recruiting
Status
- RECRUITING
Contact Person
- Grey Freylersythe, BS
- (305) 243-9832
- [email protected]
Principal Investigator
- Tracy Crane, PhD, RDN
Eligibility Criteria
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 60-90-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 competition of primary treatment, with no evidence of primary disease
6. Approval from treating oncologist, confirmed via email or in writing
7. Internet access on a smart phone, tablet, or computer
8. 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
Low Complexity Group
EXPERIMENTAL
Participants in this group will receive the low complexity intervention for up to eight (8) weeks.
OTHER:
FitbitDescription:
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 CourseDescription:
The virtual, synchronous nutrition course will be a 30-60 minute group education class on nutrition information for cancer survivors. The class will be held once per week.BEHAVIORAL:
Physical Activity ProgramDescription:
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.
Moderate Complexity Group
EXPERIMENTAL
Participants in this group will receive the moderate complexity intervention for up to eight (8) weeks.
OTHER:
FitbitDescription:
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 CourseDescription:
The virtual, synchronous nutrition course will be a 30-60 minute group education class on nutrition information for cancer survivors. The class will be held once per week.BEHAVIORAL:
Physical Activity ProgramDescription:
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 PrescriptionDescription:
The nutrition prescription pad serves as a quick checklist designed to assist participants in effectively monitoring their dietary habits. Participants randomized to intervention group will each receive a one-time nutrition prescription in person during their first intervention week.BEHAVIORAL:
Physical Activity PrescriptionDescription:
The physical activity prescription pad serves as a quick checklist designed to assist participants in effectively monitoring their exercise routines. Participants randomized to intervention group will each receive a one-time physical prescription in person during their first intervention week.
High Complexity Group
EXPERIMENTAL
Participants in this group will receive the high complexity intervention for up to eight (8) weeks.
OTHER:
FitbitDescription:
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 CourseDescription:
The virtual, synchronous nutrition course will be a 30-60 minute group education class on nutrition information for cancer survivors. The class will be held once per week.BEHAVIORAL:
Physical Activity ProgramDescription:
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:
Weekly One on One Session with Registered DietitianDescription:
Participants will be referred to weekly one on one 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:
Weekly One on One Session with an Exercise PhysiologistDescription:
Participants will be referred to weekly one on one sessions with an Exercise Physiologist. The one on one sessions are anticipated to last 30-60 minutes, based on the needs of the individual
Control Group
NO_INTERVENTION
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.
Outcome Measures
Primary Outcome Measures
Percentage of Survivors Who Agree to Participate
Percentage of Interventions Sessions Completed
Percentage of Participants Satisfied with the Intervention
Timeline
Last Updated
October 10, 2024Start Date
August 2, 2024Today
February 5, 2025Completion Date ( Estimated )
September 30, 2027
Sponsors of this trial
Lead Sponsor
University of MiamiCollaborating Sponsors
The Applebaum Foundation