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临床试验/NCT00376909
NCT00376909已完成2 期

New York Prevention Care Manager Project

Dartmouth-Hitchcock Medical Center3 个研究点 分布在 1 个国家目标入组 2,729 人开始时间: 2001年11月最近更新:
适应症

试验速览

阶段
2 期
状态
已完成
入组人数
2,729
试验地点
3
主要终点
Screening rates as measured by mammography, Pap test, hfoBT, sigmoidoscopy, barium enema and colonoscopy

研究概览

简要总结

RATIONALE: Studying the barriers that prevent minority and low-income women from undergoing cancer screening, and offering encouragement to them over the telephone, may help improve cancer screening rates.

PURPOSE: This randomized phase II trial is studying how well a telephone-based Prevention Care Manager increases screening rates for breast cancer, cervical cancer, and colorectal cancer in minority and low-income women.

详细描述

OBJECTIVES:

  • Determine whether telephone support for patients, provided through a Prevention Care Manager (PCM), can increase breast, cervical, and colorectal cancer screening rates among minority and low-income women.
  • Measure the amount of PCM time required to improve early cancer detection provided to age-eligible ethnically diverse women seen in community health centers in the New York City area.
  • Learn barriers faced by this population in obtaining indicated services (mammograms, Pap tests, fecal occult blood testing, and sigmoidoscopy).
  • Assess at baseline and follow-up the office environment and work processes in each participating center (in PCM randomized controlled study only).
  • Develop and implement the PCM intervention to help patients overcome barriers.
  • Evaluate the impact and costs of the PCM in a randomized controlled efficacy trial.

OUTLINE: This is a randomized, controlled, single-blind, multicenter study. Patients are randomized according to participating center.

  • Part 1: Some patients undergo a series of structured interviews about the obstacles to early cancer detection. Participating sites are assessed for study eligibility.

  • Part 2: Pilot testing, training, and competency testing of the Prevention Care Managers (PCM) are conducted.

  • Part 3: Patients are randomized to 1 of 2 intervention arms.

  • Arm I: Patients are offered health education and follow-up services by telephone with a PCM.

  • Arm II: Patients receive usual care.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Single Group
主要目的
Screening
盲法
None

入排标准

年龄范围
40 Years 至 69 Years(Adult, Older Adult)
性别
Female
接受健康志愿者

入选标准

  • 未提供

排除标准

  • 未提供

结局指标

主要结局

Screening rates as measured by mammography, Pap test, hfoBT, sigmoidoscopy, barium enema and colonoscopy

Follow-up patient cancer 3 months after completion of study treatment

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (3)

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