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.
Who Can Participate?
Eligibility
Adults ages 18-39 who:<ul>
<li>Were diagnosed with cancer between the ages of 15 and 39</li>
<li>Have completed cancer treatment in the last 5 years</li>
<li>Have a body mass index (BMI) of 30 or greater</li>
<li>Are able to participate in home-based exercise</li>
<li>Live within 60 miles of Duke campus</li></ul>
For more information about who can be in this study, please contact the study team at 919-681-8437 or <a href="mailto: Michael.W.Willis@duke.edu">Michael.W.Willis@duke.edu.</a>
<li>Were diagnosed with cancer between the ages of 15 and 39</li>
<li>Have completed cancer treatment in the last 5 years</li>
<li>Have a body mass index (BMI) of 30 or greater</li>
<li>Are able to participate in home-based exercise</li>
<li>Live within 60 miles of Duke campus</li></ul>
For more information about who can be in this study, please contact the study team at 919-681-8437 or <a href="mailto: Michael.W.Willis@duke.edu">Michael.W.Willis@duke.edu.</a>
Age Range
18-39
Sex/Genders
Male (cisgender)
Female (cisgender)
Non-binary or gender fluid
Transgender male
Transgender female
Looking for Healthy Participants
No
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:<ul>
<li>Answer questions about your symptoms, emotions, health behaviors, and health history</li>
<li>Complete a 6-minute walk test</li>
<li>Have your height, weight, and bood pressure measured</li>
<li>Provide a urine sample, if you are a person who could become pregnant</li>
<li>Have a blood draw, to measure your cholesterol levels and your hemoglobin A1C (average blood sugar level)</li></ul>
If you are assigned to the healthy lifestyle program, we will also ask you to:<ul>
<li>Complete 8 one-hour sessions with a study therapist over video (Zoom®) over the course of 10 to 12 weeks</li>
<li>Wear a wireless activity tracker (Garmin®) that we will provide you</li>
<li>Measure your blood pressure and weigh yourself using Bluetooth-enabled devices (Qardio®) provided by the study team</li></ul>
<li>Answer questions about your symptoms, emotions, health behaviors, and health history</li>
<li>Complete a 6-minute walk test</li>
<li>Have your height, weight, and bood pressure measured</li>
<li>Provide a urine sample, if you are a person who could become pregnant</li>
<li>Have a blood draw, to measure your cholesterol levels and your hemoglobin A1C (average blood sugar level)</li></ul>
If you are assigned to the healthy lifestyle program, we will also ask you to:<ul>
<li>Complete 8 one-hour sessions with a study therapist over video (Zoom®) over the course of 10 to 12 weeks</li>
<li>Wear a wireless activity tracker (Garmin®) that we will provide you</li>
<li>Measure your blood pressure and weigh yourself using Bluetooth-enabled devices (Qardio®) provided by the study team</li></ul>
Locations
Pickett Road Research
Visit Timing
Weekdays
Compensation
Yes
Spanish Materials Available
No
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
PRO00110049
NCT ID
NCT05869604
Phase
N/A
Enrollment Status
Open to Enrollment