Precise Oncology Interventions in Nutrition and Training (OnPoint)

Clinicaltrials.gov ID: NCT06534918
db-list-check Status RECRUITING
b-loader Phase NA
b-people Age ≥ 18 Years
b-bullseye-arrow Enrollments 306

Conditions

Breast Cancer, Prostate Cancer, Colorectal Cancer

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.

Locations

1 location Found with status Recruiting

Status

  • RECRUITING

Contact Person

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:

    Fitbit

    Description:

    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 Course

    Description:

    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 Program

    Description:

    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:

    Fitbit

    Description:

    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 Course

    Description:

    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 Program

    Description:

    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 Prescription

    Description:

    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 Prescription

    Description:

    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:

    Fitbit

    Description:

    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 Course

    Description:

    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 Program

    Description:

    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 Dietitian

    Description:

    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 Physiologist

    Description:

    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

    Time Frame: Up to 8 Weeks

    Percentage of Interventions Sessions Completed

    Time Frame: Up to 8 Weeks

    Percentage of Participants Satisfied with the Intervention

    Time Frame: Up to 8 Weeks

    Timeline

    • Last Updated
      October 10, 2024
    • Start Date
      August 2, 2024
    • Today
      February 5, 2025
    • Completion Date ( Estimated )
      September 30, 2027

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