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Reducing Underuse of Early-Stage Breast Cancer Treatment in Minority Communities

This study is currently recruiting participants.
Verified by Mount Sinai School of Medicine, September 2005

Sponsored by: Mount Sinai School of Medicine
Information provided by: Mount Sinai School of Medicine
ClinicalTrials.gov Identifier: NCT00145197
  Purpose

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
Breast Cancer
Behavioral: Improving the Delivery of Effective Care to Minorities

Genetics Home Reference related topics:   breast cancer   

MedlinePlus related topics:   Breast Cancer    Cancer   

U.S. FDA Resources

Study Type:   Interventional
Study Design:   Other, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Efficacy Study
Official Title:   Improving the Delivery of Effective Care to Minorities

Further study details as provided by Mount Sinai School of Medicine:

Primary Outcome Measures:
  • initiation and completion of primary treatment

Secondary Outcome Measures:
  • adherence, emotional and health status, patient satisfaction

Estimated Enrollment:   695
Study Start Date:   January 2004
Estimated Study Completion Date:   August 2007

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 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.

  Eligibility
Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No

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 > 1 cm or < 1 cm 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
  Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00145197

Locations
United States, New York
Mount Sinai School of Medicine     Recruiting
      New York, New York, United States, 10029
      Contact: Nina Bickell, MD     212-659-9567        

Sponsors and Collaborators
Mount Sinai School of Medicine

Investigators
Principal Investigator:     Nina Nina Bickell, MD     Mount Sinai School of Medicine    
  More Information


Study ID Numbers:   5 P01 HS10859-05
First Received:   September 2, 2005
Last Updated:   July 30, 2007
ClinicalTrials.gov Identifier:   NCT00145197
Health Authority:   United States: Institutional Review Board

Keywords provided by Mount Sinai School of Medicine:
breast cancer  
adjuvant treatment  
racial disparities  
Early-Stage Breast Cancer  

Study placed in the following topic categories:
Skin Diseases
Breast Neoplasms
Breast Diseases

Additional relevant MeSH terms:
Neoplasms
Neoplasms by Site

ClinicalTrials.gov processed this record on October 31, 2008




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