Clinical trial · Observational
Psychological Support and Psycho-Emotional Trajectories in Cancer Genetics.
Apport d'un Accompagnement Psychologique au Cours du Parcours en oncogénétique : étude de la Trajectoire Psycho-émotionnelle Des Consultants
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
Undergoing a cancer genetic testing pathway and receiving results regarding a personal or familial cancer predisposition can generate substantial, multifaceted psycho-emotional distress for patients. While professional psychological support is strongly recommended in clinical guidelines, very few studies have formally quantified its actual contribution to the longitudinal psycho-emotional experiences of patients within real-world clinical practices. The primary objective of the PsyOncoGen study is to describe the longitudinal psycho-emotional trajectories of patients within the routine care pathway. It evaluates the clinical impact of psychological support by observing the natural outcomes of patients who choose to accept this systematically offered service versus those who choose to decline it. The study will follow 220 adult patients across two natural cohorts determined solely by patient choice: 110 patients utilising the clinical psychological support and 110 patients declining it.
Conditions
Conditions (4)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Genetic Testing | — | UNRESOLVED | — |
| Hereditary Neoplastic Syndromes | — | UNRESOLVED | — |
| Neoplasms | Neoplasm | ONTOLOGY_EXACT | 0.90 |
| Psychological Distress | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Patients undergoing their first cancer genetic testing consultation who choose to follow the care pathway without utilising the systematically offered clinical psychological support. | Other | — | UNRESOLVED |
| Patients undergoing their first cancer genetic testing consultation who choose to utilise the clinical psychological support offered by the unit | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- label
- Psychological Support Group
- interventionNames
- Other: Patients undergoing their first cancer genetic testing consultation who choose to utilise the clinical psychological support offered by the unit
- label
- Group Without Psychological Support
- interventionNames
- Other: Patients undergoing their first cancer genetic testing consultation who choose to follow the care pathway without utilising the systematically offered clinical psychological support.
Primary outcomes (1)
- measure
- Longitudinal study of Psycho-Emotional Distress Scores
- timeFrame
- Up to 9 months
- description
- 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).
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available