Psychological DistressPsyOncoGenNCT07695506
Psychological Support and Psycho-Emotional Trajectories in Cancer Genetics.
An observational study of Psychological Distress and Genetic Testing, run by Assistance Publique - Hôpitaux de Paris.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Psychological Distress, Genetic Testing, Hereditary Neoplastic Syndromes
- What is being tested?
- Patients undergoing their first cancer genetic testing consultation who choose to utilise the clinical psychological support offered by the unit and Patients undergoing their first cancer genetic testing consultation who choose to follow the care pathway without utilising the systematically offered clinical psychological support.
- How many people
- 220 participants
- Where
- No sites listed yet
- Study dates
- 1 Sep 2026to 1 Jun 2028
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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).
Who may be able to join
- 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.
Who cannot join
- 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 locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: 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.
- Being tested
- Patients undergoing their first cancer genetic testing consultation who choose to utilise the clinical psychological support offered by the unit, Patients undergoing their first cancer genetic testing consultation who choose to follow the care pathway without utilising the systematically offered clinical psychological support.
- Keywords
- Hereditary Cancer Syndromes, Genetic Testing, Psychological Distress, Psychological Needs, Psycho-oncology
- Medical subject headings
- Neoplastic Syndromes, Hereditary, Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Patients undergoing their first cancer genetic testing consultation who choose to utilise the clinical psychological support offered by the unitOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Psychological Support Group | Not described Receives: 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 | Not described Receives: Other: Patients undergoing their first cancer genetic testing consultation who choose to follow the care pathway without utilising the systematically offered clinical psychological support. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: Up to 9 months
Secondary outcomes (4)
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).
Measured: 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).
Measured: 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).
Measured: 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.
Measured: Up to 9 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jul 2026
- Study start1 Sep 2026 (estimated)
- Primary completion1 Jun 2028 (estimated)
- Study completion1 Jun 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Psychological DistressStudies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de ParisThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 220 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07695506
- Sponsor's protocol ID
- APHP260600
- Acronym
- PsyOncoGen
- Status last verified
- Jul 2026
- First submitted
- 6 Jul 2026
- Last updated
- 10 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 10 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Apport d'un Accompagnement Psychologique au Cours du Parcours en oncogénétique : étude de la Trajectoire Psycho-émotionnelle Des Consultants
- ClinicalTrials.gov ID
- NCT07695506
- Acronym / sponsor ID
- PsyOncoGen / APHP260600
- Keywords
- Hereditary Cancer Syndromes, Genetic Testing, Psychological Distress, Psychological Needs, Psycho-oncology
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 220 participants (estimated)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Study start
- 1 Sep 2026 (estimated)
- Primary completion
- 1 Jun 2028 (estimated)
- Study completion
- 1 Jun 2028 (estimated)
- First posted
- 10 Jul 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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).
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Patients undergoing their first cancer genetic testing consultation who choose to utilise the clinical psychological support offered by the unitThis 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 | Psychological Support Group |
| 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. | Other | Group Without Psychological Support |
Primary outcome
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).
4 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jul 2026.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Questions about this trial
What is this clinical trial studying?
An observational study of Psychological Distress and Genetic Testing, run by Assistance Publique - Hôpitaux de Paris.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 10 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Marie-Charlotte Villy, MD (01.42.49.47.98 ext. +33, marie-charlotte.villy@aphp.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Longitudinal study of Psycho-Emotional Distress Scores (time frame: Up to 9 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Jul 2026.