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
- 2
- 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
研究组 & 干预措施
Phase 1:Observe communication between physicians and cancer patients
- Observation of the 10 consultations : To ensure heterogeneous sampling, a varied panel of prescribing physicians will be selected, taking into account gender, age and specialty (oncologist versus organ specialist).
- Conduct a semi-structured interview within 10 days of the consultation with 10 new patients who have been prescribed a theranostic exome analysis by a researcher
- Thematic content analysis of 10 consultation observations by SHS researchers and 10 semi-structured interviews which will enable us to assess the degree of understanding of the information provided by the doctor, and whether it answers the patient's questions.
干预措施: Cancer patients' preferences regarding genetic information modalities prior to theranostic exome analysis (Other)
Phase 2 : Revisit existing information media (GGC information note and video).
These materials will serve as a basis for our work, and may be adapted according to the results of phase 1 of our study. We will seek the advice of a partner patient, who will himself have benefited from a genetic analysis in the context of cancer, and who will be made aware of clinical research.
Phase 3:Assess patients' preferences with regard to 3 information modalities
- A medical consultation, during which the doctor will provide each of the 60 patients with the standard form of information, together with the explanatory note (INFOGene study)
- Within 10 days, a semi-structured interview with 30 of the 60 patients. These 30 patients will be selected to ensure maximum socio-demographic and clinical (cancer location) heterogeneity.
- Division of the 60 patients into 3 groups of 20 stratified according to age, gender and cancer location, including 10 previously interviewed (one group will receive the information based solely on the video worked previously, one group will receive the information during a consultation, one group will receive the information first via the video and then during a consultation).
- The researcher conducts a new semi-structured interview with the 60 patients. They will provide an insight into patients' experience of the information they receive (content, form, timing).
干预措施: Cancer patients' preferences regarding genetic information modalities prior to theranostic exome analysis (Other)
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