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

NCT00145197 | Completed

• 2 other identifiers: GCO 00-00535P01HS010859-05
• Study Type: interventional
• Target: 1,164
• Locations: 1 country
• Sites: 1

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.

Conditions

Breast Cancer

Keywords

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

Outcome Measures

Primary Outcomes (1)

• initiation and completion of primary treatment

  measured 6 months after patient recruitment

Secondary Outcomes (4)

• adherence

  measured at time of patient survey

• emotional and health status

  measured at time of patient survey

• patient satisfaction

  measured at time of patient survey

• knowledge & beliefs

  measured at time of patient survey

Study Arms (1)

Improving the Delivery of Effective Care to Minorities

EXPERIMENTAL

Behavioral: Improving the Delivery of Effective Care to Minorities

Interventions

Improving the Delivery of Effective Care to Minorities BEHAVIORAL

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.

Improving the Delivery of Effective Care to Minorities

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Icahn School of Medicine at Mount Sinai: lead

Study Sites (1)

Icahn School of Medicine at Mount Sinai

New York, New York, 10029, United States

Location

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Nina Bickell, MD

  Icahn School of Medicine at Mount Sinai

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 2, 2005
• First Posted: September 5, 2005
• Study Start: January 1, 2004
• Primary Completion: December 1, 2007
• Study Completion: December 1, 2007
• Last Updated: December 3, 2013

Record last verified: 2013-12

Locations

US (1)