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 @ 7:16 PM
Ignite Modification Date:
2025-12-24 @ 7:16 PM
NCT ID:
NCT04306003
Eligibility Criteria:
Inclusion Criteria:
1. Women of age 18 years or greater
2. Able to understand and communicate in English
3. Diagnosis of breast cancer or BRCA gene
4. Undergoing (or previously had) unilateral or bilateral mastectomy
5. Undergoing immediate or delayed DIEP breast reconstruction (unilateral or bilateral).
Patients undergoing repeat breast reconstruction (secondary reconstruction) after a previously failed alloplastic or autologous reconstruction will be eligible to participate.
Patients undergoing both DIEP and alloplastic reconstruction (e.g. DIEP reconstruction for one breast, alloplastic reconstruction for the other breast) will also be eligible to participate.
Exclusion Criteria:
1. Non-ambulatory at baseline
2. Pregnant
3. Unable to provide informed consent or unable to complete quality of life questionnaires due to mental capacity, cognitive impairment, or language barrier.
Healthy Volunteers:
False
Sex:
FEMALE
Minimum Age:
18 Years
Study:
NCT04306003
Study Brief:
Protocol Section:
NCT04306003