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Trial Title:
Study of Cancer Patients' Preferences for Genetic Information Modalities Preceding Theranostic Exome Analysis.
NCT ID:
NCT06550687
Condition:
All Types of Metastatic Solid Malignancy
1st-line Treatment
Exome Analysis
Active File EXOMA2 Study
Conditions: Official terms:
Neoplasms
Study type:
Interventional
Study phase:
N/A
Overall status:
Not yet recruiting
Study design:
Allocation:
Non-Randomized
Intervention model:
Sequential Assignment
Primary purpose:
Other
Masking:
None (Open Label)
Intervention:
Intervention type:
Other
Intervention name:
Cancer patients' preferences regarding genetic information modalities prior to theranostic exome analysis
Description:
Phase 1: Observation of doctor-patient consultations Phase 2: Adaptation of information
tools Phase 3: Assessment of understanding of information tools
Arm group label:
Phase 1:Observe communication between physicians and cancer patients
Arm group label:
Phase 3:Assess patients' preferences with regard to 3 information modalities
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.
Criteria for 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
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Centre Georges-François Leclerc
Address:
City:
Dijon
Zip:
21000
Country:
France
Contact:
Last name:
Sophie Nambot, Dr
Phone:
0380295313
Phone ext:
+33
Email:
snambot@cgfl.fr
Contact backup:
Last name:
Sophie Parnalland
Phone:
0345348077
Phone ext:
+33
Email:
sparnalland@cgfl.fr
Facility:
Name:
CHU François Mitterand
Address:
City:
Dijon
Zip:
21000
Country:
France
Contact:
Last name:
Sophie Nambot, Dr
Phone:
0380295313
Phone ext:
+33
Email:
sophie.nambot@chu-dijon.fr
Start date:
September 1, 2024
Completion date:
November 1, 2026
Lead sponsor:
Agency:
Centre Georges Francois Leclerc
Agency class:
Other
Source:
Centre Georges Francois Leclerc
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06550687
