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临床试验/NCT00617071
NCT00617071Unknown3 期

Tailored Navigation in CRC Screening

Sidney Kimmel Comprehensive Cancer Center at Thomas Jefferson University2 个研究点 分布在 1 个国家目标入组 900 人开始时间: 2007年1月1日最近更新:
适应症

试验速览

阶段
3 期
入组人数
900
试验地点
2
主要终点
Screening utilization over the 6-month observation period

研究概览

简要总结

RATIONALE: Developing a personalized screening plan may be more effective than usual care in increasing the number of healthy participants who regularly undergo screening for colorectal cancer.

PURPOSE: This randomized phase III trial is studying personalized screening plans to see how well they work compared with usual care in increasing colorectal cancer screening in healthy participants.

详细描述

OBJECTIVES:

  • To compare the impact of tailored intervention vs standard intervention vs usual care on patient utilization of colorectal cancer (CRC) screening.
  • To compare the impact of these interventions on CRC screening preference.
  • To compare the impact of these interventions on patient perceptions about CRC screening.

OUTLINE: This is a multicenter study. Participants are stratified by practice and study wave and blocking. Participants are randomized to 1 of 3 arms.

  • Arm I (usual care): Participants receive usual care in accordance with their normal patterns of interaction with study practices.
  • Arm II (standard intervention [SI]): A generic screening invitation letter, a colorectal cancer (CRC) screening informational booklet, stool blood testing (SBT) cards, and instructions for arranging a colonoscopy screening appointment are mailed to participants on day 15. On day 45, a reminder letter is mailed to participants who have not completed SBT or undergone a screening colonoscopy.
  • Arm III (tailored navigation intervention [TNI]): A test-specific screening invitation letter, a CRC screening informational booklet, and additional test-specific materials (i.e., instructions for arranging a colonoscopy screening appointment or SBT cards) are mailed to participants on day 15. On day 30, a patient navigator contacts participants by telephone who have not completed SBT or undergone a screening colonoscopy. The patient navigator re-assesses screening test-specific decision stage; addresses CRC screening barriers; develops a personalized CRC screening plan to move the participant towards screening use (i.e., explains the steps in completing the SBT or scheduling a colonoscopy appointment); and facilitates screening plan implementation. On day 45, a reminder letter is mailed to participants who were contacted by the navigator.

Participants in all arms complete a survey at baseline and then at 6 months. Medical records for each participant are reviewed at 6 months.

研究设计

研究类型
Interventional
分配方式
Randomized
主要目的
Health Services Research
盲法
Single

入排标准

年龄范围
50 Years 至 74 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • DISEASE CHARACTERISTICS:
  • Meets the following criteria:
  • No personal history of colorectal neoplasia (cancer or polyps) or inflammatory bowel disease
  • No family history of colorectal cancer (CRC) diagnosed before the age of 60
  • Visited one of the six community-based primary care practices that are part of the Christiana Care Health System (CCHS) in Delaware within the past 2 years
  • Not up-to-date with CRC screening, according to the United States Preventive Services Task Force guidelines
  • PATIENT CHARACTERISTICS:
  • Must have a complete address and telephone number
  • Able to communicate in English
  • No psychosis or severe dementia
  • PRIOR CONCURRENT THERAPY:
  • No prior participation in the developmental study CA10241

排除标准

  • 未提供

结局指标

主要结局

Screening utilization over the 6-month observation period

次要结局

  • Screening preference
  • Perceived salience and coherence and self-efficacy related to colorectal cancer (CRC) screening
  • Number and length of contacts with each participant and the type of communication during those contacts
  • Identification of predictors of CRC screening use and screening preference

研究者

研究点 (2)

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