Precise Oncology Interventions in Nutrition and Training (OnPoint)

University of Miami

Status: Enrolling

Conditions: Breast Cancer; Prostate Cancer; Colorectal Cancer

Treatments: Behavioral: Nutrition and Physical Activity Prescription; Behavioral: Physical Activity Program: Group Sessions; Behavioral: Nutrition Course: Group Sessions; Other: Fitbit; Behavioral: Physical Activity Program: One on One Sessions with an Exercise Physiologist; Behavioral: Nutrition Course: One on One Sessions with Registered Dietitian

Study type: Interventional

Funder types: Other

Identifiers

NCT06534918

20230533

Details and patient eligibility

About

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.

Enrollment: 306 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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 30-60-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 completion of primary treatment, with no evidence of primary disease
6. Approval from treating oncologist, confirmed via email or in writing
7. 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.
8. Internet access on a smart phone, tablet, or computer
9. 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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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306 participants in 4 patient groups

Low Complexity Group

Experimental group

Description:

Participants in this group will receive the low complexity intervention for up to eight (8) weeks.

Treatment:

Other: Fitbit

Behavioral: Nutrition and Physical Activity Prescription

Moderate Complexity Group

Experimental group

Description:

Participants in this group will receive the moderate complexity intervention for up to eight (8) weeks.

Treatment:

Other: Fitbit

Behavioral: Nutrition Course: Group Sessions

Behavioral: Nutrition and Physical Activity Prescription

Behavioral: Physical Activity Program: Group Sessions

High Complexity Group

Experimental group

Description:

Participants in this group will receive the high complexity intervention for up to eight (8) weeks.

Treatment:

Behavioral: Nutrition Course: One on One Sessions with Registered Dietitian

Behavioral: Physical Activity Program: One on One Sessions with an Exercise Physiologist

Other: Fitbit

Behavioral: Nutrition and Physical Activity Prescription

Control Group

No Intervention group

Description:

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.