Viewing Study NCT00145197



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Last Modification Date: 2024-10-26 @ 9:14 AM
Study NCT ID: NCT00145197
Status: COMPLETED
Last Update Posted: 2013-12-03
First Post: 2005-09-02

Brief Title: Reducing Underuse of Early-Stage Breast Cancer Treatment in Minority Communities
Sponsor: Icahn School of Medicine at Mount Sinai
Organization: Icahn School of Medicine at Mount Sinai

Study Overview

Official Title: Improving the Delivery of Effective Care to Minorities
Status: COMPLETED
Status Verified Date: 2013-12
Last Known Status: None
Delayed Posting: No
If Stopped, Why?: Not Stopped
Has Expanded Access: False
If Expanded Access, NCT#: N/A
Has Expanded Access, NCT# Status: N/A
Acronym: None
Brief Summary: The purpose of this study is to determine if a physician-centered intervention will help women with early stage breast cancer receive appropriate treatment
Detailed Description: Efficacious adjuvant treatments such as radiotherapy following breast conserving surgery and chemo- or hormonal therapy for stage 1b or 2 breast cancer improve disease-free and overall survival Lower rates of radiotherapy following breast-conserving surgery have been reported among black women Few data exist about racial disparities in receipt of chemo- or hormonal therapies however poorer stage-specific survival rates among blacks and among women with poor or no insurance suggest underuse of these treatments Despite elimination of racial disparities in rates of mammography screening the full benefit of screening will not be realized unless underuse of effective treatments for early-stage breast cancer is eliminated Little is known about reasons for underuse of these treatments or ways to increase treatment rates Our preliminary work suggests omitted referrals and lack of follow-up tracking account for a majority of underuse particularly among minority patients

The proposed breast cancer project will measure the extent of underuse of efficacious breast cancer treatments among patients of the hospitals serving East and Central Harlem and other minority communities in lower Manhattan We will first interview physicians and patients about their reasons for omission of efficacious adjuvant treatments At the 6 participating hospitals we will then implement an intervention consisting of a computerized reminders to prompt surgeons to refer patients for adjuvant treatment and b an individual to track referrals for and receipt of adjuvant treatments We will assess racialethnic differences in rates of underuse and explore racial differences in reasons for underuse

We will assess the impact of the intervention on reducing underuse of efficacious therapies among 2 years of 695 pre-intervention and 2 years of 695 post-intervention patients This study will provide new knowledge about racial disparities in treatment for early-stage breast cancer patient and physician reasons for underuse and the effectiveness of a simple sustainable intervention to improve rates of efficacious adjuvant treatments

Study Oversight

Has Oversight DMC: None
Is a FDA Regulated Drug?: None
Is a FDA Regulated Device?: None
Is an Unapproved Device?: None
Is a PPSD?: None
Is a US Export?: None
Is an FDA AA801 Violation?: None
Secondary IDs
Secondary ID Type Domain Link
5P01HS010859-05 AHRQ None httpsreporternihgovquickSearch5P01HS010859-05