Status:
COMPLETED
A Research Study for Latina Women Undergoing Breast Cancer Treatment
Lead Sponsor:
Northwestern University
Conditions:
Cancer-related Problem/Condition
Quality of Life
Eligibility:
FEMALE
21+ years
Phase:
NA
Brief Summary
The purpose of this study is to examine the effects of a developed psychosocial eHealth intervention on the proposed primary outcomes, health-related quality of life and symptom burden, among Hispanic...
Detailed Description
Among Hispanics, the largest and fastest growing ethnic minority group in the U.S., cancer is the leading cause of death whereas cardiovascular disease is the leading cause of death for African Americ...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
September 10 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2022
Estimated Enrollment :
51 Patients enrolled
Trial Details
Trial ID
NCT04064151
Start Date
September 10 2019
End Date
July 1 2022
Last Update
November 9 2022
Active Locations (1)
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1
Northwestern University
Chicago, Illinois, United States, 60611