Precise Oncology Interventions in Nutrition and Training (OnPoint)

Not Applicable

Recruiting

• Conditions: Breast Cancer; Colorectal Cancer; Prostate Cancer
• Interventions: Other: Fitbit; Behavioral: Nutrition Course; Behavioral: Physical Activity Program; Behavioral: Nutrition Prescription; Behavioral: Weekly One on One Session with Registered Dietitian; Behavioral: Physical Activity Prescription; Behavioral: Weekly One on One Session with an Exercise Physiologist

• Registration Number: NCT06534918
• Lead Sponsor: University of Miami

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2024-07-30
• Study First Submitted QC: 2024-07-30
• Study First Posted: 2024-08-02
• Study Start: 2024-09-18
• Status Verified: 2024-10
• Last Update Submitted: 2024-10-07
• Last Update Posted: 2024-10-10
• Primary Completion: 2027-09-30
• Study Completion: 2027-09-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 306

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Moderate Complexity Group	Nutrition Prescription	Participants in this group will receive the moderate complexity intervention for up to eight (8) weeks.
Low Complexity Group	Physical Activity Program	Participants in this group will receive the low complexity intervention for up to eight (8) weeks.
Low Complexity Group	Fitbit	Participants in this group will receive the low complexity intervention for up to eight (8) weeks.
Moderate Complexity Group	Fitbit	Participants in this group will receive the moderate complexity intervention for up to eight (8) weeks.
Moderate Complexity Group	Nutrition Course	Participants in this group will receive the moderate complexity intervention for up to eight (8) weeks.
Moderate Complexity Group	Physical Activity Prescription	Participants in this group will receive the moderate complexity intervention for up to eight (8) weeks.
High Complexity Group	Weekly One on One Session with Registered Dietitian	Participants in this group will receive the high complexity intervention for up to eight (8) weeks.
Low Complexity Group	Nutrition Course	Participants in this group will receive the low complexity intervention for up to eight (8) weeks.
High Complexity Group	Fitbit	Participants in this group will receive the high complexity intervention for up to eight (8) weeks.
High Complexity Group	Nutrition Course	Participants in this group will receive the high complexity intervention for up to eight (8) weeks.
Moderate Complexity Group	Physical Activity Program	Participants in this group will receive the moderate complexity intervention for up to eight (8) weeks.
High Complexity Group	Physical Activity Program	Participants in this group will receive the high complexity intervention for up to eight (8) weeks.
High Complexity Group	Weekly One on One Session with an Exercise Physiologist	Participants in this group will receive the high complexity intervention for up to eight (8) weeks.

Primary Outcome Measures

Name	Time	Method
Percentage of Interventions Sessions Completed	Up to 8 Weeks	Percentage of intervention sessions completed will be reported as ≥ 80%.
Percentage of Survivors Who Agree to Participate	Up to 8 Weeks	Percentage of survivors who agree to participate will be reported as ≥ 50%.
Percentage of Participants Satisfied with the Intervention	Up to 8 Weeks	Report of 80% satisfaction will be determined as satisfaction with intervention components.

Trial Locations

Locations (1)

University of Miami; 🇺🇸 Miami, Florida, United States