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NCT Number: NCT07695506

Psychological Support and Psycho-Emotional Trajectories in Cancer Genetics.

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.

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Key information

Conditions

Psychological Distress Congenital, Hereditary, and Neonatal Diseases and Abnormalities Genetic Diseases, Inborn Genetic Testing Hereditary Neoplastic Syndromes Neoplasms Neoplastic Syndromes, Hereditary

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

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.

Primary outcomes

  1. Longitudinal study of Psycho-Emotional Distress Scores

    Time frame: Up to 9 months

    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).

Secondary outcomes

  1. Evolution of Psycho-Emotional Distress Post-Disclosure.

    Time frame: Up to 9 months

    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).

  2. Specific Hereditary Cancer Psychosocial Concerns.

    Time frame: Up to 9 months

    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).

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

    Time frame: Up to 9 months

    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).

  4. Clinical Psychological Trajectories and Psychological Support Adherence

    Time frame: Up to 9 months

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

Jérôme Lambert, MD PhD

CONTACT

[email protected]

0142499742 ext. +33

Marie-Charlotte Villy, MD

CONTACT

[email protected]

01.42.49.47.98 ext. +33

Sponsors and collaborators

Lead sponsor

Assistance Publique - Hôpitaux de Paris

Other

Registry information

Official study title

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

Acronym: PsyOncoGen

Important dates

Study start
2026
Primary completion
2028
Study completion
2028
First posted
Jul 10, 2026
Registry last updated
Jul 10, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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