Tailored Navigation in CRC Screening
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
- 是
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
