Psychological Support and Psycho-Emotional Trajectories in Cancer Genetics. (PsyOncoGen)
Apport d'un Accompagnement Psychologique au Cours du Parcours en oncogénétique : étude de la Trajectoire Psycho-émotionnelle Des Consultants
Studieoversikt
Status
Intervensjon / Behandling
- Annen: Patients undergoing their first cancer genetic testing consultation who choose to utilise the clinical psychological support offered by the unit
- Annen: Patients undergoing their first cancer genetic testing consultation who choose to follow the care pathway without utilising the systematically offered clinical psychological support.
Studietype
Registrering (Antatt)
Kontakter og plasseringer
Studiekontakt
- Navn: Jérôme Lambert, MD PhD
- Telefonnummer: +33 0142499742
- E-post: jerome.lambert@u-paris.fr
Studer Kontakt Backup
- Navn: Marie-Charlotte Villy, MD
- Telefonnummer: +33 01.42.49.47.98
- E-post: marie-charlotte.villy@aphp.fr
Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
- Voksen
- Eldre voksen
Tar imot friske frivillige
Prøvetakingsmetode
Studiepopulasjon
Beskrivelse
Inclusion Criteria:
- Adult individuals referred for their first genetic counselling consultation, with an indication for a genetic test;
- Individuals capable of understanding and expressing themselves sufficiently in French (able to complete questionnaires and participate in interviews);
- Must not present with neurocognitive or psychopathological disorders, or impairments that could compromise their understanding of the study and informed decision-making regarding participation;
- Affected or unaffected index case or relatives.
Exclusion Criteria:
- Individuals under guardianship, curatorship, or a legal protection order, or deprived of liberty by a judicial or administrative decision;
- Individuals presenting with neurocognitive or psychopathological disorders and/or linguistic difficulties that preclude understanding the study and questionnaires, or participating in an informed manner;
- Individuals already enrolled in a hereditary cancer testing care pathway.
Studieplan
Hvordan er studiet utformet?
Designdetaljer
Kohorter og intervensjoner
Gruppe / Kohort |
Intervensjon / Behandling |
|---|---|
|
Psychological Support Group
|
This includes structured clinical interviews with the unit's psychologist within 15 days following the initial consultation (T1), 15 days following result disclosure (T2), and 2.5 months post-disclosure.
Patients can change their choice at any point if their support needs change.
|
|
Group Without Psychological Support
|
To ensure equity of care, these patients maintain the right to request and access the psychological support program at any time during their pathway if their needs change.
|
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Longitudinal study of Psycho-Emotional Distress Scores
Tidsramme: Up to 9 months
|
Evaluated using the scores of the Hospital Anxiety and Depression Scale (HADS) at each key milestone to compare longitudinal trajectories between patients receiving psychological support and those who do not. The HADS is a 14-item self-report questionnaire consisting of an Anxiety subscale (7 items, score range 0-21) and a Depression subscale (7 items, score range 0-21), yielding a total distress score range from 0 to 42. Higher scores indicate greater severity of psycho-emotional distress. Assessed at three key time points: initial consultation (T1), the genetic test result disclosure (T2), and at three months post-disclosure (T3). |
Up to 9 months
|
Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Evolution of Psycho-Emotional Distress Post-Disclosure.
Tidsramme: Up to 9 months
|
Measured using the Hospital Anxiety and Depression Scale (HADS) scores to analyse the evolution of general distress. Data will be analysed based on the type of genetic result (pathogenic variant, variant of uncertain significance, negative result), the specific primary cancer site and patient demographics (age, sex, etc.). Measured from genetic test result disclosure (T2) to the three-month post-disclosure follow-up (T3). |
Up to 9 months
|
|
Specific Hereditary Cancer Psychosocial Concerns.
Tidsramme: Up to 9 months
|
Measured using the French version of the Psychosocial Aspects of Hereditary Cancer questionnaire, to study specific psychosocial needs. For each of the 6 distinct dimensions, raw scores are summed and normalised to a 0-100 scale. A higher score represents increasing psychosocial difficulties and challenges within the specific dimension. Assessed at initial genetics consultation (T1), genetic test result disclosure (T2), and three-month post-disclosure (T3). |
Up to 9 months
|
|
Interrelations and variations of Emotional Distress and Psychosocial Concerns (HADS & PAHC-French).
Tidsramme: Up to 9 months
|
Evaluated using the concurrent scores of both of the HADS and PAHC-French questionnaires to explore the relations between general emotional distress and specific psychosocial concerns in clinical cancer genetics. Assessed at initial genetics consultation (T1), genetic test result disclosure (T2), and three months post-disclosure (T3). |
Up to 9 months
|
|
Clinical Psychological Trajectories and Psychological Support Adherence
Tidsramme: Up to 9 months
|
Based on the qualitative clinical assessment and follow-up notes compiled by the unit's clinical psychologist. This metric is used to describe the participant's real-world psychological pathways, specifically tracking and documenting any adjustments or changes in their use of psychological support throughout the care pathway. Documented within 15 days following T1, T2 and 2.5 months after T2, following each interview with the clinical psychologist. |
Up to 9 months
|
Samarbeidspartnere og etterforskere
Studierekorddatoer
Studer hoveddatoer
Studiestart (Antatt)
Primær fullføring (Antatt)
Studiet fullført (Antatt)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Faktiske)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Nøkkelord
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- APHP260600
Plan for individuelle deltakerdata (IPD)
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