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 @ 7:47 PM
Ignite Modification Date:
2025-12-24 @ 7:47 PM
NCT ID:
NCT01043003
Eligibility Criteria:
Inclusion
* Histologically confirmed diagnosis of stage 0 (DCIS), I, II, or III breast cancer
* No evidence of recurrent, metastatic, or second primary cancer
* Completing primary treatment with surgery, radiation therapy (if indicated), and/or adjuvant chemotherapy (if indicated)
* Subjects may be on hormonal therapy after treatment for initial breast cancer
* Self-identification as Hispanic/Latino
* Able to read and understand English or Spanish to participate in the patient teaching
* Able and willing to participate in the study
* The Caregiver selection criteria is: self-identification as the primary caregiver; age 18 years or over; self-identification as Hispanic/Latino; Able to read and speak English or Spanish; Able and willing to participate in the study
Exclusion
* Patients will be excluded if they are actively receiving treatment with surgery, radiation therapy, or chemotherapy; patients may be receiving adjuvant hormonal therapy such as Tamoxifen during the course of the study since it is recommended for five years after primary and adjuvant therapy
* Patients who have recurrence, metastasis, or a second primary cancer will not be recruited for the study; if however, they develop recurrence, metastasis, or a second primary cancer during the time of the study participation, the subjects will remain in the study
* Patients will not be recruited directly from support groups because of potential bias inherent in sample attending support groups; however, some patients may be participating in support groups or other forms of counseling
Healthy Volunteers:
True
Sex:
FEMALE
Minimum Age:
18 Years
Study:
NCT01043003
Study Brief:
Protocol Section:
NCT01043003