Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 7:58 PM
Ignite Modification Date:
2025-12-24 @ 7:58 PM
NCT ID:
NCT03542604
Eligibility Criteria:
Inclusion Criteria:
* Female
* 18 years of age or older
* Histologically-confirmed ductal carcinoma in-situ (DCIS) or stage I-III invasive carcinoma of the breast
* Current BMI ≥ 25 kg/m2 and weight ≤ 400 lbs
* Willing to lose 10% of body weight
* Diagnosed with current breast cancer \>3 and \<60 months from planned baseline visit date
* Completed local therapy (i.e. surgery and radiation therapy) and any planned preoperative or adjuvant chemotherapy within \>3 prior to enrollment
* Diagnosed with insomnia or reports sleep problems
* Has daily access to the internet and/or smartphone
Exclusion Criteria:
* Serious/uncontrolled condition likely to hinder accurate measurement of weight or sleep, such as bipolar I, seizure disorders, autoimmune disease, etc., or a medical condition that makes physical activity unsafe
* Current use of weight loss medications or sleeping aids
* Current enrollment in a sleep or weight loss program
* Sleep disorder other than insomnia
* Plan to become pregnant within next 12 months, or lactating
Healthy Volunteers:
False
Sex:
FEMALE
Minimum Age:
18 Years
Study:
NCT03542604
Study Brief:
Protocol Section:
NCT03542604