Study of Cancer Patients' Preferences for Genetic Information Modalities Preceding Theranostic Exome Analysis. Qualitative Observational and Interventional Cross-sectional Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 80
- 试验地点
- 4
- 主要终点
- Concepts of communication and preferences.
研究概览
简要总结
Currently, the EXOMA2 study (NCT04614480) offers earlier and more comprehensive exome analysis in the management of cancer patients than EXOMA. Based on the active EXOMA2 patient file, the INFOGene study offers the opportunity to study patient-physician communication, to assess patient preferences with regard to different information modalities concerning theranostic exome analysis, and to reflect on information modalities to ensure optimal patient comprehension of the information provided.
The qualitative cross-sectional study includes a dual observational and interventional component involving cancer patients. The patients will come from the EXOMA 2 active file at Dijon University Hospital and the CGFL.
详细描述
Currently, the EXOMA2 study (NCT04614480) offers earlier and more comprehensive exome analysis in the management of cancer patients than EXOMA. Based on the active EXOMA2 patient file, the INFOGene study offers the opportunity to study patient-physician communication, to assess patient preferences with regard to different information modalities concerning theranostic exome analysis, and to reflect on information modalities to ensure optimal patient comprehension of the information provided.
The qualitative cross-sectional study includes a dual observational and interventional component involving cancer patients. The patients will come from the EXOMA 2 active file at Dijon University Hospital and the CGFL.
Phase 1 will aim to observe and analyze interpersonal communication between physicians prescribing theranostic exome analysis and cancer patients. It will be based on:
1/ ethnographic exploratory observations of 10 consultations during which the doctor will suggest that the patient undergo theranostic exome analysis, and 2/ semi-directed interviews with 10 new patients who have previously seen the doctor.
The patients will come from the EXOMA 2 active file at Dijon University Hospital and the CGFL.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Sequential
- 主要目的
- Other
- 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
- 否
入选标准
- •Patient identified for inclusion in the EXOMA 2 study (exome analysis request)
- •Available to receive different types of information
- •Fluent in French
- •No prior oncogenetic consultation
- •Having been informed of the objectives of the study and having given written non-objection to participate in the INFOGene study
- •Authorizing audio recording of consultations and interviews
排除标准
- •Patient who refused to participate in the EXOMA2 study (for phase 3 patients only)
- •Has a psychiatric, cognitive or neurological disorder that makes participation impossible
- •Working in the field of genetics
结局指标
主要结局
Concepts of communication and preferences.
时间窗: Through study completion, an average of 21 months.
The various interviews (phases 1 and 3) will provide an insight into patients' level of health literacy, which may explain the ease or difficulty of exchanges with the doctor (phase 1), as well as patients' preferences for one type of information over another (phase 3).
次要结局
未报告次要终点