Psychological Support and Psycho-Emotional Trajectories in Cancer Genetics.

Official title

Apport d'un Accompagnement Psychologique au Cours du Parcours en oncogénétique : étude de la Trajectoire Psycho-émotionnelle Des Consultants

Overview

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.

Interventions

• Other Patients undergoing their first cancer genetic testing consultation who choose to utilise the clinical psychological support offered by the unit
  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.
• Other Patients undergoing their first cancer genetic testing consultation who choose to follow the care pathway without utilising the systematically offered clinical 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.

Primary outcome measures

• Longitudinal study of Psycho-Emotional Distress Scores [Time frame: Up to 9 months]

Secondary outcome measures (4)

• Evolution of Psycho-Emotional Distress Post-Disclosure. [Time frame: Up to 9 months]
• Specific Hereditary Cancer Psychosocial Concerns. [Time frame: Up to 9 months]
• Interrelations and variations of Emotional Distress and Psychosocial Concerns (HADS & PAHC-French). [Time frame: Up to 9 months]
• Clinical Psychological Trajectories and Psychological Support Adherence [Time frame: Up to 9 months]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Observational model

Cohort

Study locations

Center list to be confirmed — check the primary protocol.

Identifiers

NCT: NCT07695506 · APHP260600

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗