IFACT: Incidental Findings in Advanced Cancer Therapy
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- qualitive data
研究概览
简要总结
The proposed study, IFACT - Incidental Findings in Advanced Cancer Therapy, will address this research gap by examining MSK patients' attitudes, preferences, and information needs regarding incidental findings arising from tumor genomic profiling.
详细描述
Part 1, the investigators will recruit 40 participants from those already enrolled in existing MSK IRB protocol #12-245 (PI: David Hyman, MD) including male and female patients who have been diagnosed with late-stage breast, colorectal, bladder, and lung cancer (some of the most common cancers in this study population).
Part 2, the investigators will recruit 20 participants from those who have actually received incidental germline findings from MSK IRB protocol #12-245 Consent Part C in order to cognitively test novel survey items about their knowledge and perceived utility of their incidental findings (note that the content of these items will be derived from the data collected in Part 1)
研究设计
- 研究类型
- Observational
- 观察模型
- Case Crossover
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patient enrolled on MSK protocol #12-245
- •Living patient age 18 or older
- •Patient diagnosed with breast cancer, colorectal cancer, bladder cancer, or lung cancer
- •Patient residing in New York metro-area
- •Living patient age 18 or older
- •Consented to Part C of IRB#12-245 and has received results regardless if thereir was a pathogenic variant
- •Patient diagnosed with cancer type approved for IRB#12-245 Part C (which are currently breast cancer, gynecological cancer, prostate cancer, and GU non-prostate cancer)breast cancer, colorectal cancer, bladder cancer, or lung cancer
- •Patient residing in New York metro-area
- •Exclusion Criteria for Part 1 and 2:
- •Non-English speakers because we do not have the resources to conduct and translate the interviews into other languages.
- •Patient unwilling or unable to provide informed consent.
排除标准
- 未提供
结局指标
主要结局
qualitive data
时间窗: one time
The study team will review and code the interview transcripts through a process of independent and collaborative thematic content analysis,(25-28) using ATLAS.ti (a qualitative data analysis software package) to facilitate the analysis process (29).
次要结局
未报告次要终点