Early-Stage Breast Cancer Clinical Trial
Official title:
Patient Assistance to Reduce Breast Cancer Disparities
The purpose of this study is to determine whether patient-assistance programs as compared with usual care will help women with early stage breast cancer receive appropriate treatments.
Status | Completed |
Enrollment | 374 |
Est. completion date | January 2011 |
Est. primary completion date | June 2010 |
Accepts healthy volunteers | No |
Gender | Female |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: - All patients, who are English or Spanish speaking, with a new primary stage 1 or 2 breast cancer who have undergone either breast conserving surgery or mastectomy and those with tumors >1cm or <1cm and poorly differentiated; - All surgeons performing breast surgery at the participating hospitals Exclusion Criteria: - Patients with dementia or those with a poor prognosis due to end-stage organ failure or other concomitant conditions such as those undergoing treatment for other cancers |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver)
Country | Name | City | State |
---|---|---|---|
United States | Albert Einstein College of Medicine | New York | New York |
United States | Columbia University | New York | New York |
United States | Harlem Hospital Center | New York | New York |
United States | Icahn School of Medicine at Mount Sinai | New York | New York |
United States | Metropolitan Hospital | New York | New York |
United States | Montefiore Medical Center | New York | New York |
United States | Elmhurst Hospital Center | Queens | New York |
United States | Queens Hospital Center | Queens | New York |
Lead Sponsor | Collaborator |
---|---|
Icahn School of Medicine at Mount Sinai | National Cancer Institute (NCI) |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | initiation and completion of primary treatment | Measured after completion of 6-mth interview | No | |
Secondary | adherence | Measured after completion of 6-mth interview | No | |
Secondary | emotional and health status | Measured at baseline | No | |
Secondary | emotional and health status | Measured after completion of 6-mth interview | No | |
Secondary | patient satisfaction | measured at baseline | No | |
Secondary | patient satisfaction | Measured after completion of 6-mth interview | No |
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