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Improving the Delivery of Effective Care to Minorities

18 Years
Not Enrolling
Breast Cancer

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Trial Information

Improving the Delivery of Effective Care to Minorities

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.

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

Type of Study:


Study Design:

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label

Outcome Measure:

initiation and completion of primary treatment

Outcome Time Frame:

measured 6 months after patient recruitment

Safety Issue:


Principal Investigator

Nina Bickell, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Mount Sinai School of Medicine


United States: Institutional Review Board

Study ID:

5 P01 HS10859-05



Start Date:

January 2004

Completion Date:

December 2007

Related Keywords:

  • Breast Cancer
  • breast cancer
  • adjuvant treatment
  • racial disparities
  • Early-Stage Breast Cancer
  • Breast Neoplasms



Mount Sinai School of Medicine New York, New York  10029