Psychological Support and Psycho-Emotional Trajectories in Cancer Genetics.

NCT07695506 | Not Yet Recruiting

• 1 other identifier: APHP260600
• Study Type: observational
• Target: 220
• Locations: 0 countries
• Sites: N/A

Brief Summary

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

Psychological Distress; Genetic Testing; Hereditary Neoplastic Syndromes; Neoplasms

Keywords

Hereditary Cancer Syndromes; Genetic Testing; Psychological Distress; Psychological Needs; Psycho-oncology

Outcome Measures

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).

  Up to 9 months

Secondary Outcomes (4)

• Evolution of Psycho-Emotional Distress Post-Disclosure.

  Up to 9 months

• Specific Hereditary Cancer Psychosocial Concerns.

  Up to 9 months

• Interrelations and variations of Emotional Distress and Psychosocial Concerns (HADS & PAHC-French).

  Up to 9 months

• Clinical Psychological Trajectories and Psychological Support Adherence

  Up to 9 months

Study Arms (2)

Psychological Support Group

Other: Patients undergoing their first cancer genetic testing consultation who choose to utilise the clinical psychological support offered by the unit

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.

Interventions

Patients undergoing their first cancer genetic testing consultation who choose to follow the care pathway without utilising the systematically offered clinical psychological support. OTHER

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.

Group Without Psychological Support

Patients undergoing their first cancer genetic testing consultation who choose to utilise the clinical psychological support offered by the unit OTHER

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.

Psychological Support Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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).

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Assistance Publique - Hôpitaux de Paris: lead

MeSH Terms

Conditions

Neoplastic Syndromes, Hereditary; Neoplasms

Condition Hierarchy (Ancestors)

Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Central Study Contacts

Marie-Charlotte Villy, MD

CONTACT

01.42.49.47.98; marie-charlotte.villy@aphp.fr

Jérôme Lambert, MD PhD

CONTACT

0142499742; jerome.lambert@u-paris.fr

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 6, 2026
• First Posted: July 10, 2026
• Study Start (Estimated): September 1, 2026
• Primary Completion (Estimated): June 1, 2028
• Study Completion (Estimated): June 1, 2028
• Last Updated: July 10, 2026

Record last verified: 2026-07