跳至主要内容
临床试验/NCT00145197
NCT00145197已完成不适用

Improving the Delivery of Effective Care to Minorities

Icahn School of Medicine at Mount Sinai1 个研究点 分布在 1 个国家目标入组 1,164 人开始时间: 2004年1月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
1,164
试验地点
1
主要终点
initiation and completion of primary treatment

研究概览

简要总结

The purpose of this study is to determine if a physician-centered intervention will help women with early stage breast cancer receive appropriate treatment.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
盲法
None

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
Female
接受健康志愿者

入选标准

  • 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

排除标准

  • 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

结局指标

主要结局

initiation and completion of primary treatment

时间窗: measured 6 months after patient recruitment

次要结局

  • 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)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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