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 @ 11:53 PM
Ignite Modification Date:
2025-12-24 @ 11:53 PM
NCT ID:
NCT04064151
Eligibility Criteria:
Inclusion Criteria:
* Female
* Diagnosis of breast cancer, non-metastatic, stage 0-IIIA; for women diagnosed with stage 0, either radiation or chemotherapy is required as an additional treatment to surgery
* Currently undergoing cancer treatment \[e.g., surgery, chemotherapy, radiation, or combination of the two or three\]
* at least 21 years of age
* Able to speak and read English or Spanish
* Able to provide informed consent
* Elevated score on breast cancer symptom burden and HRQoL, measured by the Functional Assessment of Cancer Therapy-Breast questionnaire using an established cut-off score for clinically meaningful, compromised HRQoL
* Self-identified Hispanic/Latina ethnicity.
Exclusion Criteria:
* Visual, hearing, voice, or motor impairment that would prevent completion of study procedures
* diagnosis of an unmanaged psychotic disorder, bipolar disorder, dissociative disorder, or other diagnosis for which participation in this trial is either inappropriate or dangerous - this includes patients who have life-threatening illness (e.g., end-stage kidney disease) or diagnosis of a chronic disease that is associated with a major functional impairment (e.g., fibromyalgia)
* Illicit substance or alcohol dependence
* Suicidal ideation, plan, intent
* Alzheimer's, dementia or history of stroke
* Scheduled reconstruction surgery within 1 month of any study procedures or involvement.
Healthy Volunteers:
False
Sex:
FEMALE
Minimum Age:
21 Years
Study:
NCT04064151
Study Brief:
Protocol Section:
NCT04064151