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
This trial accepts healthy volunteersQualifiers
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 population
Adults attending a hereditary cancer consultation at Saint-Louis Hospital for a known or suspected hereditary cancer syndrome, with a clinical indication for genetic testing (including affected or unaffected index cases or relatives).
Trial design
Design model
Cohort
Time perspective
Prospective
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
Other interventionThis 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.
Patients undergoing their first cancer genetic testing consultation who choose to follow the care pathway without utilising the systematically offered clinical psychological support.
Other interventionTo 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.
Treatment groups
220 Participants
are divided into 2 treatment groupsGroup A: Psychological Support Group1 intervention
Group B: Group Without Psychological Support1 intervention
Trial outcomes
Primary outcomes
1
Longitudinal study of Psycho-Emotional Distress Scores
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).
Time frame
Up to 9 monthsSecondary outcomes
1
Evolution of Psycho-Emotional Distress Post-Disclosure.
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).
Time frame
Up to 9 months2
Specific Hereditary Cancer Psychosocial Concerns.
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).
Time frame
Up to 9 months3
Interrelations and variations of Emotional Distress and Psychosocial Concerns (HADS & PAHC-French).
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).
Time frame
Up to 9 months4
Clinical Psychological Trajectories and Psychological Support Adherence
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.
Time frame
Up to 9 monthsLocations
Sponsors and contacts
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Source ClinicalTrials.gov
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