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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Mount Sinai School of Medicine
ClinicalTrials.gov Identifier:
NCT00145197
First received: September 2, 2005
Last updated: December 2, 2013
Last verified: December 2013
  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

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Official Title: Improving the Delivery of Effective Care to Minorities

Resource links provided by NLM:


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

Primary Outcome Measures:
  • initiation and completion of primary treatment [ Time Frame: measured 6 months after patient recruitment ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • adherence [ Time Frame: measured at time of patient survey ] [ Designated as safety issue: No ]
  • emotional and health status [ Time Frame: measured at time of patient survey ] [ Designated as safety issue: No ]
  • patient satisfaction [ Time Frame: measured at time of patient survey ] [ Designated as safety issue: No ]
  • knowledge & beliefs [ Time Frame: measured at time of patient survey ] [ Designated as safety issue: No ]

Enrollment: 1164
Study Start Date: January 2004
Study Completion Date: December 2007
Primary Completion Date: December 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Improving the Delivery of Effective Care to Minorities Behavioral: Improving the Delivery of Effective Care to Minorities
The intervention consists of: a) 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 recruit all physicians who treat patients with early stage breast cancer. Physicians who agree to participate will identify a point person in their office who will inform the research team if the patient has a follow up appointment with radiation or medical oncologists. Following the appointment date, we will contact each office to confirm the patient's visit. If the patient has connected with radiation and/or medical oncologist, we will let the surgeon's office know and stop calling his/her office. However, if the patient has not made the appropriate visits, we will continue to call the surgeon's office every week for a total of 3 calls to let them know that the patient has not connected with the oncologist.

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
Icahn School of Medicine at Mount Sinai
New York, New York, United States, 10029
Sponsors and Collaborators
Mount Sinai School of Medicine
Investigators
Principal Investigator: Nina Bickell, MD Mount Sinai School of Medicine
  More Information

No publications provided

Responsible Party: Mount Sinai School of Medicine
ClinicalTrials.gov Identifier: NCT00145197     History of Changes
Other Study ID Numbers: GCO 00-0053, 5 P01 HS10859-05
Study First Received: September 2, 2005
Last Updated: December 2, 2013
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

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases

ClinicalTrials.gov processed this record on April 15, 2014