Diabetes Prevention Program With or Without Hunger Training in Helping to Lower Breast Cancer Ris… (NCT03546972) | Clinical Trial Compass
Active — Not RecruitingNot Applicable
Diabetes Prevention Program With or Without Hunger Training in Helping to Lower Breast Cancer Risk in Obese Participants
United States51 participantsStarted 2017-12-17
Plain-language summary
This pilot trial studies how well a diabetes prevention program with or without hunger training works in helping to lower breast cancer risk in obese participants. A diabetes prevention program involves learning about and receiving materials on different strategies to encourage weight loss, and hunger training involves learning how to recognize hunger. It is not yet known whether adding hunger training to a diabetes prevention program helps participants control their weight that could reduce the risk of some cancers.
Who can participate
Age range
30 Years – 70 Years
Sex
FEMALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Body Mass Index (BMI) \>= 27 kg/m\^2.
* At high risk of developing breast cancer defined by one or more of the following: Gail model lifetime risk \> 20% or a 5 year risk \>1.66%, a history of deleterious BRCA1/2 mutation or mantle radiation, a history of ductal cancer in situ, or a history of high risk premalignant breast lesion.
* 12 months without a period/menstrual cycle or having had a bilateral oophorectomy.
* Ability to take digital time stamped photos.
* Internet access (daily).
* Reports being proficient in English (can read/write and speak fluently).
Exclusion Criteria:
* Previous participation in this trial. Participation is defined as screening. Re-screening is not allowed except for individuals excluded for BMI. Patients previous screened as ineligible due to BMI are allowed to be re-screened and enrolled if eligible.
* Has a current measured BMI less than 27 kg/m\^2.
* Reports being unwilling to use Continuous Glucose Monitor (CGM), which requires daily blood sampling by finger pricks.
* Currently being actively treated for cancer other than nonmelanoma skin cancer.
* Known inability to participate in the ongoing appointments for the four months of the study and scheduled follow-up tests.
* Reported current diagnosis or history of type I diabetes or type 2 diabetes.
* Reported use of oral antidiabetic agents (OADs).
* Current use of any drug (except metformin) or anticipated change in concomitant medication, which the investigator's opin…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Feasibility of adding hunger training (HT) to Diabetes Prevention Program (DPP) as assessed by recruitment rate
Timeframe: Up to 2 years
2
Feasibility of adding hunger training (HT) to Diabetes Prevention Program (DPP) as assessed by drop-out rates
Timeframe: Up to 2 years
3
Feasibility of adding hunger training (HT) to Diabetes Prevention Program (DPP) as assessed by completion rates