Improving Cardiovascular Disease Risk for Young Adult Cancer Survivors - Clinical Trial

What is the Purpose of this Study?

We are doing this study to test a program that is designed to help young cancer survivors improve how well they follow diet and exercise guidelines, manage their weight, and cope with physical and emotional symptoms that can interfere with diet, exercise, and weight management.

What is the Condition Being Studied?

Teen and young adult cancer survivors who may be at risk for cardiovascular disease due to cancer treatment

Who Can Participate in the Study?

Adults ages 18-39 who:

  • Were diagnosed with cancer between the ages of 15 and 39
  • Have completed cancer treatment in the last 5 years
  • Have a body mass index (BMI) of 30 or greater
  • Are able to participate in home-based exercise
  • Live within 60 miles of Duke campus

For more information about who can be in this study, please contact the study team at 919-681-8437 or Michael.W.Willis@duke.edu.

Age Group
Adults

What is Involved?

If you take part in this study, you will get a random assignment (like a coin flip) to receive either a healthy lifestyle behavior program or your usual medical care. We will schedule you to complete an in-person study visit when you begin the study and again about 3 months later. At each visit, you will:

  • Answer questions about your symptoms, emotions, health behaviors, and health history
  • Complete a 6-minute walk test
  • Have your height, weight, and bood pressure measured
  • Provide a urine sample, if you are a person who could become pregnant
  • Have a blood draw, to measure your cholesterol levels and your hemoglobin A1C (average blood sugar level)

If you are assigned to the healthy lifestyle program, we will also ask you to:

  • Complete 8 one-hour sessions with a study therapist over video (Zoom®) over the course of 10 to 12 weeks
  • Wear a wireless activity tracker (Garmin®) that we will provide you
  • Measure your blood pressure and weigh yourself using Bluetooth-enabled devices (Qardio®) provided by the study team

Study Details

Full Title
Improving Cardiovascular Disease Risk Factors in Survivors of Adolescent and Young Adult Cancer with Obesity: Adaptation and Pilot Testing of a Behavioral Weight and Symptom Management Intervention
Principal Investigator
Caroline Dorfman
Protocol Number
IRB: PRO00110049
NCT: NCT05869604
Phase
Phase N/A
ClinicalTrials.gov
Enrollment Status
Open for Enrollment
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