Purpose

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.

Conditions

Eligibility

Eligible Ages
Over 18 Years
Eligible Sex
All
Accepts Healthy Volunteers
Yes

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

Study Design

Phase
N/A
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Supportive Care
Masking
Single (Investigator)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
Low Complexity Group
Participants in this group will receive the low complexity intervention for up to eight (8) weeks.
  • Other: Fitbit
    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 and Physical Activity Prescription
    Participants will receive a lifestyle medicine prescription pad, developed by the investigators, which serves as a checklist to assist participants in effectively monitoring their dietary habits and physical activity routines. Participants will also receive an 8-week text messages program which will direct participants to a webpage with nutrition and physical activity content.
Experimental
Moderate Complexity Group
Participants in this group will receive the moderate complexity intervention for up to eight (8) weeks.
  • Other: Fitbit
    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: Group Sessions
    The nutrition course will follow a combined asynchronous and synchronous approach. The asynchronous component will consist of a pre-recorded session covering educational nutrition content, which will be made available to participants for self-paced learning. This will be followed by a synchronous, 30-60 minute live group education class on nutrition information for cancer survivors, held once per week.
  • Behavioral: Physical Activity Program: Group Sessions
    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 and Physical Activity Prescription
    Participants will receive a lifestyle medicine prescription pad, developed by the investigators, which serves as a checklist to assist participants in effectively monitoring their dietary habits and physical activity routines. Participants will also receive an 8-week text messages program which will direct participants to a webpage with nutrition and physical activity content.
Experimental
High Complexity Group
Participants in this group will receive the high complexity intervention for up to eight (8) weeks.
  • Other: Fitbit
    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: One on One Sessions with Registered Dietitian
    Participants will be referred to weekly one on one nutrition counseling 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: Physical Activity Program: One on One Sessions with an Exercise Physiologist
    Participants will be referred to weekly one on one exercise training sessions with an Exercise Physiologist. The one on one sessions are anticipated to last 30-60 minutes, based on the needs of the individual
  • Behavioral: Nutrition and Physical Activity Prescription
    Participants will receive a lifestyle medicine prescription pad, developed by the investigators, which serves as a checklist to assist participants in effectively monitoring their dietary habits and physical activity routines. Participants will also receive an 8-week text messages program which will direct participants to a webpage with nutrition and physical activity content.
No Intervention
Control Group
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.

Recruiting Locations

University of Miami
Miami 4164138, Florida 4155751 33136
Contact:
Grey Freylersythe, BS
305-243-9832
g.freylersythe@med.miami.edu

More Details

NCT ID
NCT06534918
Status
Recruiting
Sponsor
University of Miami

Study Contact

Grey Freylersythe, BS
305-243-9832
g.freylersythe@med.miami.edu

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.