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
Descripción general del estudio
Estado
Intervención / Tratamiento
- Otro: Patients undergoing their first cancer genetic testing consultation who choose to utilise the clinical psychological support offered by the unit
- Otro: Patients undergoing their first cancer genetic testing consultation who choose to follow the care pathway without utilising the systematically offered clinical psychological support.
Tipo de estudio
Inscripción (Estimado)
Contactos y Ubicaciones
Estudio Contacto
- Nombre: Jérôme Lambert, MD PhD
- Número de teléfono: +33 0142499742
- Correo electrónico: jerome.lambert@u-paris.fr
Copia de seguridad de contactos de estudio
- Nombre: Marie-Charlotte Villy, MD
- Número de teléfono: +33 01.42.49.47.98
- Correo electrónico: marie-charlotte.villy@aphp.fr
Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
- Adulto
- Adulto Mayor
Acepta Voluntarios Saludables
Método de muestreo
Población de estudio
Descripción
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.
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
Cohortes e Intervenciones
Grupo / Cohorte |
Intervención / Tratamiento |
|---|---|
|
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.
|
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Longitudinal study of Psycho-Emotional Distress Scores
Periodo de tiempo: 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
|
Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Evolution of Psycho-Emotional Distress Post-Disclosure.
Periodo de tiempo: 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.
Periodo de tiempo: 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).
Periodo de tiempo: 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
Periodo de tiempo: 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
|
Colaboradores e Investigadores
Patrocinador
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Estimado)
Finalización primaria (Estimado)
Finalización del estudio (Estimado)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Actual)
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- APHP260600
Plan de datos de participantes individuales (IPD)
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Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
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