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临床试验/NCT00375024
NCT00375024已完成不适用

Patient Navigator Project

H. Lee Moffitt Cancer Center and Research Institute2 个研究点 分布在 1 个国家目标入组 1,267 人开始时间: 2007年5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
1,267
试验地点
2
主要终点
Questionnaire Results Regarding Time to Diagnosis

研究概览

简要总结

Patient Navigation is a Supportive Care Intervention that addresses barriers to quality standard care by providing individualized assistance to patients and families. The NCI is conducting several research programs to test the effectiveness of this approach. The expected outcomes of patient navigation through the cancer care system include:

  • Timely, definitive diagnosis following an abnormal test
  • Timely treatment following positive diagnosis
  • Patient satisfaction with the diagnostic and care system experience

详细描述

The goal of our local project is to provide Tampa Bay with a culturally appropriate Patient Navigator Program that will decrease delay in diagnosis and delivery of cancer care in an acceptable and cost-effective manner leading to lower cancer mortality among our underserved populations. We will partner with community health centers in the Tampa Bay area to provide an avenue for patients who have received an abnormal screening for breast and colorectal cancer to easier pilot the course of the healthcare system. The populations served by this program will include African-Americans, Hispanics and rural Whites who are medically underserved due to lack of insurance, documentation issues and a variety of other barriers to health care.

The primary outcome to be tested with this program is the time it takes for patients with an abnormality to receive a definitive diagnosis. Secondary outcomes such as patient satisfaction and cost-effectiveness will also be measured. This program occurs in three phases. In Phase I, the aim is to work closely with our key community partners to conduct formative research for the development of an acceptable, appealing, and appropriate Patient Navigator Program. The aim for Phase II is to conduct a group randomized controlled trial by having participating clinics randomly assigned to an intervention or control clinic. The outcomes from this phase in the project will be assessed through chart reviews, patient satisfaction surveys and other survey methods. In Phase III a comprehensive evaluation on the program will be produced and disseminated nationally.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Supportive Care
盲法
None

入排标准

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

入选标准

  • Receive health care at one of the enrolled clinics
  • Newly diagnosed with breast of colorectal cancer or if they have an abnormality that is suspicious for breast (breast lump, or abnormal mammogram) or colorectal cancer (abnormal colon screening test, blood in bowel movement).

排除标准

  • Persons with previous history of breast or colon cancer will be excluded from the study

结局指标

主要结局

Questionnaire Results Regarding Time to Diagnosis

时间窗: Individual per patient

Time from finding of abnormality to definitive diagnosis

次要结局

  • Patient Satisfaction Questionaire Results(At end of patient participation)
  • Questionnaire Results Regarding Patient Navigators(End of study)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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