Facilitating Informed Decisions for MSI Testing
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 239
- 试验地点
- 3
- 主要终点
- Impact of Standard Informed Consent vs CD-ROM Educational Intervention on Knowledge About Microsatellite Instability (MSI) Testing
研究概览
简要总结
RATIONALE: The use of a CD-ROM may help patients with colorectal cancer or a family history of colorectal cancer make informed decisions about undergoing microsatellite instability (MSI) testing.
PURPOSE: This randomized clinical trial is studying an educational CD-ROM to see how well it works compared with standard informed consent to assist decision-making about MSI testing in patients with colorectal cancer or a family history of colorectal cancer.
详细描述
OBJECTIVES:
Primary
- Compare the impact of standard informed consent vs a CD-ROM educational intervention on knowledge about microsatellite instability (MSI) testing in patients with colorectal cancer (CRC) or a family history of CRC.
- Determine the impact of these interventions on patient satisfaction with the preparation to make a decision.
Secondary
- Determine whether the CD-ROM educational intervention has a differential impact on satisfaction with the MSI test decision, difficulty making the MSI test decision, and decisional conflict, as well as on patients' attitudes about MSI testing and CRC (e.g., perceived benefits and barriers to having the MSI test, perceived risk for colorectal and related cancers, self-efficacy), on general and cancer-related distress, and on discussions with family members about the MSI test and familial CRC risk.
- Assess whether demographic factors, disease/family history characteristics, family support for testing, and cancer-related distress moderate the impact of the intervention on satisfaction with and completeness of the informed consent process.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 盲法
- None
入排标准
- 年龄范围
- 21 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patient or family member meeting 1 of the following revised Bethesda colorectal cancer (CRC) criteria:
- •Diagnosis of colon or rectal cancer at < 50 years of age
- •Diagnosis of > 1 CRC at one time in the past
- •Diagnosis of ≥ 1 CRC at different times
- •Diagnosis of CRC and any other hereditary nonpolyposis colorectal cancer (HNPCC)-related cancers
- •Diagnosis of CRC in ≥ 2 first-degree or second-degree relatives with HNPCC-related tumor and ≥ 1 cancer diagnosed at < 50 years of age
- •Diagnosis of CRC in ≥ 2 first- or second-degree relatives with HNPCC-related tumors, regardless of age
- •Diagnosis of CRC with pathologic features suggestive of microsatellite instability (MSI) and < 60 years of age
- •Patients with CRC meeting the Amsterdam criteria defined below are ineligible:
- •Three relatives with CRC with 1 being a first-degree relative of the other 2
- •Cases that span ≥ 2 generations
- •At least 1 CRC case diagnosed before 50 years of age
- •PATIENT CHARACTERISTICS:
- •Not specified
- •PRIOR CONCURRENT THERAPY:
- •Not specified
排除标准
- 未提供
研究组 & 干预措施
Counseling
Participants will be given one of two counseling interventions regarding MSI testing: standard counseling or a CD-ROM intervention.
干预措施: counseling intervention (Other)
Counseling
Participants will be given one of two counseling interventions regarding MSI testing: standard counseling or a CD-ROM intervention.
干预措施: CD-ROM intervention (Other)
结局指标
主要结局
Impact of Standard Informed Consent vs CD-ROM Educational Intervention on Knowledge About Microsatellite Instability (MSI) Testing
时间窗: 2 weeks after enrollment
10-item true/false MSI knowledge survey developed by the oncologists on trial. (e.g., "Microsatellite Instability is found in every person that has had cancer."; "Microsatellite Instability may be caused by a permanent change in a gene that is inherited from a person's mother or father."). Participants can score anywhere from 0 (no questions answered correctly) to 10 (all questions answered correctly).
次要结局
- Differential Impact of CD-ROM on Satisfaction With MSI Test Decision, Difficulty Making Decision & Decisional Conflict; Attitude; General & Cancer-related Distress; Discussions With Family About MSI Test & Familial Colorectal Cancer Risk(at enrollment and 2 weeks after enrollment)
- Impact of Demographic Factors, Disease/Family History Characteristics, Family Support, and Cancer-related Distress on Satisfaction With and Completeness of the Informed Consent Process(at enrollment and 2 weeks after enrollment)
- Patient Satisfaction With the Preparation to Make a Decision(at enrollment and 2 weeks after enrollment)