Ignite Creation Date:
2024-10-26 @ 3:37 PM
Last Modification Date:
2024-10-26 @ 3:37 PM
Study NCT ID:
NCT06550687
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-08-06
Brief Title:
Study of Cancer Patients Preferences for Genetic Information Modalities Preceding Theranostic Exome Analysis
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Study of Cancer Patients Preferences for Genetic Information Modalities Preceding Theranostic Exome Analysis Qualitative Observational and Interventional Cross-sectional Study
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
INFOGENE
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
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 patients needs
Step 1d thematic content analysis
Phase 2 will consist in revisiting existing information supp orts genetic counselors 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
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 patients needs
Step 1d thematic content analysis
Phase 2 will consist in revisiting existing information supp orts genetic counselors 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None