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 @ 12:05 PM
Ignite Modification Date:
2025-12-24 @ 12:05 PM
NCT ID:
NCT07101861
Eligibility Criteria:
Inclusion Criteria:
* Self-identify as non-Hispanic Black
* Self-identify as cisgendered female.
* Are ≥ age 18.
* Have a history of stage 0-3 breast cancer diagnosis treated for curative intent.
* Have completed all adjuvant or neoadjuvant chemotherapy, radiation, and surgery at least 21 days prior to study registration but may continue on hormonal therapy and Abemaciclib therapy.
* Have a measured BMI ≥ 30 kg/m2.
* Willing to participate for the entire 4-month duration.
Exclusion Criteria:
* Are pregnant or are planning to become pregnant during the study period.
* Have a known major medical or psychological condition known to influence weight loss \[e.g., medicated or poorly controlled diabetes (HbA1c \> 8%), uncontrolled hypertension (BP\>160 mm Hg systolic or BP\>100 mm Hg diastolic), cardiovascular event in the past 12 months, history of gastric bypass or bariatric surgery\].
* History of psychiatric hospitalization in past 2 years.
* History of substance abuse or eating disorder.
* Any other condition by which a medical professional has suggested diet modification, physical activity, and/or weight loss would be contraindicated.
Healthy Volunteers:
False
Sex:
FEMALE
Minimum Age:
18 Years
Study:
NCT07101861
Study Brief:
Protocol Section:
NCT07101861