Clinical trial NCT06550687: Study of Cancer Patients' Preferences for Genetic Information Modalities Preceding Theranostic Exome Analysis.
Official title: Study of Cancer Patients' Preferences for Genetic Information Modalities Preceding Theranostic Exome Analysis. Qualitative Observational and Interventional Cross-sectional Study
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: All Types of Metastatic Solid Malignancy
1st-line Treatment
Exome Analysis
Active File EXOMA2 Study
Lead sponsor: Centre Georges Francois Leclerc
Sponsor class: OTHER
First posted: 2024-08-13
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SEQUENTIAL
Primary purpose: OTHER

Brief summary: 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.

Detailed description: 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.

* Step 1a : - construction of a consultation observation grid (based on existing literature) / - identification and inclusion of patients and physicians observed
* Step 1b : Observation of 10 consultations with a varied panel of prescribing physicians, taking into account taking into account gender, age, specialty and a heterogeneous sample of patients in socio-demographic and clinical terms
* Step 1c : semi-structured interview within 10 days of the consultation with consultation with 10 other patients by an SHS researcher to assess the degree of of the information provided by the doctor and whether it can be used to respond to the patient's needs.
* Step 1d : thematic content analysis

Phase 2 will consist in revisiting existing information supp orts (genetic counselor's explanatory note and and video). These materials will serve as a basis for work, and can be adapted according to the needs of the client.

Phase 3 will aim to evaluate patients' preferences with respect to 3 information modalities concerning a theranostic exome analysis.

* Step 3a: medical consultation, during which the doctor will provide each of the 60 patients with the standard form of information reworked by the in phase 2
* Step 3b : semi-structured interview within 10 days with researcher with 30 of the 60 patients.
* Step 3c : 60 patients divided into 3 groups of 20 stratified by age, gender and cancer site.

and cancer location, including 10 seen in interview:

* one group will receive information based solely on the video previously previously
* one group will receive information during a consultation
* one group will receive information first via the video and then during a consultation
* Step 3d : A new semi-structured interview with the 60 patients. These interviews will be carried out within 2 weeks of the information phase, in order to limit memory bias but also to allow time for the patients to express themselves.

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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

Primary outcomes:
measure: Concepts of communication and preferences.
timeFrame: Through study completion, an average of 21 months.
Secondary outcomes:
Other outcomes:
Locations:
city: Dijon
country: France
facility: Centre Georges-François Leclerc
city: Dijon
country: France
facility: CHU François Mitterand
Study officials:
References: