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Clinical Trials/NCT06534918
NCT06534918
Recruiting
Not Applicable

Precise Oncology Interventions in Nutrition and Training (OnPoint)

University of Miami1 site in 1 country306 target enrollmentSeptember 18, 2024

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Breast Cancer
Sponsor
University of Miami
Enrollment
306
Locations
1
Primary Endpoint
Percentage of Interventions Sessions Completed
Status
Recruiting
Last Updated
7 months ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
September 18, 2024
End Date
September 30, 2027
Last Updated
7 months ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Tracy E Crane, PhD, RDN

Associate Professor

University of Miami

Eligibility Criteria

Inclusion Criteria

  • Inclusion Criteria - Healthcare Providers
  • 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
  • Inclusion Criteria - Patients
  • 18 years of age or older
  • Any sex/gender
  • Able to provide consent
  • Able to read/understand English or Spanish
  • Diagnosis of breast, prostate or colorectal cancer, 6 months post completion of primary treatment, with no evidence of primary disease

Exclusion Criteria

  • 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
  • Engaging in \>150 minutes of moderate to vigorous physical activity on average per week for the prior month
  • 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
  • History of dementia or major psychiatric disease which would interfere with study participation
  • History of recent (≤1 yr) stroke, myocardial infarction or congestive heart failure
  • Eastern Cooperative Oncology Group (ECOG) score of \>2
  • Severe lymphedema as determined by physician

Outcomes

Primary Outcomes

Percentage of Interventions Sessions Completed

Time Frame: Up to 8 Weeks

Percentage of intervention sessions completed will be reported as ≥ 80%.

Percentage of Survivors Who Agree to Participate

Time Frame: Up to 8 Weeks

Percentage of survivors who agree to participate will be reported as ≥ 50%.

Percentage of Participants Satisfied with the Intervention

Time Frame: Up to 8 Weeks

Report of 80% satisfaction will be determined as satisfaction with intervention components.

Study Sites (1)

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