The purpose of this study is to determine if a physician-centered intervention will help women with early stage breast cancer receive appropriate treatment.

Condition	Intervention
Early-Stage Breast Cancer	Behavior: Improving the Delivery of Effective Care to Minorities

Further Study Details: 

Primary Outcomes: initiation and completion of primary treatment; initiation and completion of primary treatment; initiation and completion of primary treatment
Secondary Outcomes: adherence, emotional and health status, patient satisfaction
Expected Total Enrollment:  695

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 racial/ethnic 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.

Ages Eligible for Study:  18 Years and above,  Genders Eligible for Study:  Female

Criteria

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

Please refer to this study by ClinicalTrials.gov identifier  NCT00145197

New York
      Mount Sinai School of Medicine, New York,  New York,  10029,  United States; Recruiting

Study chairs or principal investigators

Nina Nina Bickell, MD,  Principal Investigator,  Mount Sinai School of Medicine   

Study ID Numbers:  5 P01 HS10859-05
Last Updated:  September 2, 2005
Record first received:  September 2, 2005
ClinicalTrials.gov Identifier:  NCT00145197
Health Authority: United States: Institutional Review Board
ClinicalTrials.gov processed this record on 2005-09-06