Study of Cancer Patients' Preferences for Genetic Information Modalities Preceding Theranostic Exome Analysis.

NCT06550687 | Recruiting

• 1 other identifier: 2024-A00091-46
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 2

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.

Conditions

All Types of Metastatic Solid Malignancy; 1st-line Treatment; Exome Analysis; Active File EXOMA2 Study

Outcome Measures

Primary Outcomes (1)

• Concepts of communication and preferences.

  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).

  Through study completion, an average of 21 months.

Study Arms (3)

Phase 1:Observe communication between physicians and cancer patients

OTHER

* 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.

Other: Cancer patients' preferences regarding genetic information modalities prior to theranostic exome analysis

Phase 2 : Revisit existing information media (GGC information note and video).

NO INTERVENTION

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

OTHER

* 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).

Other: Cancer patients' preferences regarding genetic information modalities prior to theranostic exome analysis

Interventions

Cancer patients' preferences regarding genetic information modalities prior to theranostic exome analysis OTHER

Phase 1: Observation of doctor-patient consultations Phase 2: Adaptation of information tools Phase 3: Assessment of understanding of information tools

Phase 1:Observe communication between physicians and cancer patients; Phase 3:Assess patients' preferences with regard to 3 information modalities

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Centre Georges Francois Leclerc: lead

Study Sites (2)

Centre Georges-François Leclerc

Dijon, 21000, France

RECRUITING

CHU François Mitterand

Dijon, 21000, France

RECRUITING

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 6, 2024
• First Posted: August 13, 2024
• Study Start: September 19, 2024
• Primary Completion (Estimated): November 1, 2026
• Study Completion (Estimated): November 1, 2026
• Last Updated: February 18, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share

Locations

FR (2)