Psychological Support and Psycho-Emotional Trajectories in Cancer Genetics.
Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorAssistance Publique - Hôpitaux de Paris
About this trial
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.
Eligibility criteria
Qualifiers
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.
Disqualifiers
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.
Trial design
Treatments tested in this trial
- Patients undergoing their first cancer genetic testing consultation who choose to utilise the clinical psychological support offered by the unit
- Patients undergoing their first cancer genetic testing consultation who choose to follow the care pathway without utilising the systematically offered clinical psychological support.
Treatment groups
220 Participants
are divided into 2 treatment groupsLocations
Sponsors and collaborators
Source ClinicalTrials.gov