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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Neoplasms; Psychological Distress; Genetic Testing; Hereditary Neoplastic Syndromes
• Intervention / Treatment: Other: Patients undergoing their first cancer genetic testing consultation who choose to utilise the clinical psychological support offered by the unit; Other: Patients undergoing their first cancer genetic testing consultation who choose to follow the care pathway without utilising the systematically offered clinical psychological support.

• Study Type: Observational
• Enrollment (Estimated): 220

Contacts and Locations

• Study Contact: Name: Jérôme Lambert, MD PhD; Phone Number: +33 0142499742; Email: jerome.lambert@u-paris.fr
• Study Contact Backup: Name: Marie-Charlotte Villy, MD; Phone Number: +33 01.42.49.47.98; Email: marie-charlotte.villy@aphp.fr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

• Sampling Method: Non-Probability Sample

Study 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).

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Psychological Support Group	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.
Group Without Psychological Support	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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).	Up to 9 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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).	Up to 9 months
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).	Up to 9 months
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).	Up to 9 months
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.	Up to 9 months

Collaborators and Investigators

• Sponsor: Assistance Publique - Hôpitaux de Paris

Study record dates

Study Major Dates

• Study Start (Estimated): September 1, 2026
• Primary Completion (Estimated): June 1, 2028
• Study Completion (Estimated): June 1, 2028

Study Registration Dates

• First Submitted: July 6, 2026
• First Submitted That Met QC Criteria: July 6, 2026
• First Posted (Actual): July 10, 2026

Study Record Updates

• Last Update Posted (Actual): July 10, 2026
• Last Update Submitted That Met QC Criteria: July 6, 2026
• Last Verified: July 1, 2026

More Information

Terms related to this study

• Keywords: Psychological Distress; Genetic Testing; Psycho-oncology; Hereditary Cancer Syndromes; Psychological Needs
• Additional Relevant MeSH Terms: Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Neoplasms; Neoplastic Syndromes, Hereditary
• Other Study ID Numbers: APHP260600

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No