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

Improving the Delivery of Effective Care to Minorities

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00145197
Enrollment
1164
Registered
2005-09-05
Start date
2004-01-31
Completion date
2007-12-31
Last updated
2013-12-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Breast Cancer

Keywords

breast cancer, adjuvant treatment, racial disparities, Early-Stage Breast Cancer

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 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.

Interventions

BEHAVIORALImproving 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.

Sponsors

Icahn School of Medicine at Mount Sinai
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Masking
NONE

Eligibility

Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frame
initiation and completion of primary treatmentmeasured 6 months after patient recruitment

Secondary

MeasureTime frame
adherencemeasured at time of patient survey
emotional and health statusmeasured at time of patient survey
patient satisfactionmeasured at time of patient survey
knowledge & beliefsmeasured at time of patient survey

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026