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:
2025-12-26 @ 11:46 AM
Ignite Modification Date:
2025-12-26 @ 11:46 AM
NCT ID:
NCT04092816
Eligibility Criteria:
Inclusion Criteria for patients:
* Be a woman with metastatic (stage IV) breast cancer who has either: (1) estrogen (ER), progesterone (PR), or HER2 receptor-negative cancer and disease progression beyond first line of therapy, or (2) ER, PR, or HER2 -positive cancer and disease progression beyond two lines of therapy;
* A mother of at least one dependent child, defined as a child \<18 years of age who lives at least half-time in the home;
* Be at least 18 years of age;
* Adequate stamina to complete at least two study visits
* Able to provide informed consent
* Able to complete all study measures and visits in English;
* Be willing to participate in study visits at the North Carolina Cancer Hospital (NCCH) if they live \>75 miles away from NCCH
* Have an identified co-parent who is eligible and willing to participate in the study.
Inclusion Criteria for Co-parents:
* Be an adult man or woman who is both a partners or spouse of the patient and who would serve as the child(ren)'s primary caregiver if the patient were to become unavailable;
* Able to provide informed consent;
* Able to complete all study measures and visits in English;
* Stated willingness to comply with all study procedures; and
* Be at least 18 years of age.
Exclusion Criteria for patients and co-parents:
* Unable to participate in study visits due to illiteracy, inability to speak English or other causes.
* Live more than 75-miles away from the North Carolina Cancer Hospital (NCCH) and unable to attend study visits at NCCH (participants who live more than 75-miles away and can attend study visits at NCCH remain eligible for participation).
* Unwilling to be audio-recorded during facilitated study visits and feedback interview.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
99 Years
Study:
NCT04092816
Study Brief:
Protocol Section:
NCT04092816