Reducing Underuse of Early-Stage Breast Cancer Treatment in Minority Communities
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|ClinicalTrials.gov Identifier: NCT00145197|
Recruitment Status : Completed
First Posted : September 5, 2005
Last Update Posted : December 3, 2013
|Condition or disease||Intervention/treatment||Phase|
|Breast Cancer||Behavioral: Improving the Delivery of Effective Care to Minorities||Not Applicable|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||1164 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Improving the Delivery of Effective Care to Minorities|
|Study Start Date :||January 2004|
|Actual Primary Completion Date :||December 2007|
|Actual Study Completion Date :||December 2007|
|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.
- initiation and completion of primary treatment [ Time Frame: measured 6 months after patient recruitment ]
- adherence [ Time Frame: measured at time of patient survey ]
- emotional and health status [ Time Frame: measured at time of patient survey ]
- patient satisfaction [ Time Frame: measured at time of patient survey ]
- knowledge & beliefs [ Time Frame: measured at time of patient survey ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00145197
|United States, New York|
|Icahn School of Medicine at Mount Sinai|
|New York, New York, United States, 10029|
|Principal Investigator:||Nina Bickell, MD||Icahn School of Medicine at Mount Sinai|