Psychological Support and Psycho-Emotional Trajectories in Cancer Genetics.
- Sponsor
- Assistance Publique - Hôpitaux de Paris
- Study ID
- NCT07695506
- Status
- Not Yet Recruiting
Notify me when recruiting opens
Save your spot on the interest list for this study. We'll keep your details with this study so our team can follow up when recruiting opens.
Add your contact details and location so we can keep your interest tied to this study.
Conditions
- Genetic Testing
- Hereditary Neoplastic Syndromes
- Neoplasms
- Psychological Distress
Eligibility Criteria
- Sex
- ALL
- Age
- 18 Years - N/A
- Healthy Volunteers
- Accepted
Interventions
- Patients undergoing their first cancer genetic testing consultation who choose to utilise the clinical psychological support offered by the unit — OTHERThis 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. — OTHERTo 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 Details
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.
Key Dates
- First listed
- Jul 10, 2026
- Start date
- Sep 1, 2026
- Status verified
- Jul 2026
- Primary completion
- Jun 1, 2028
- Completion
- Jun 1, 2028
Study Design
- Enrollment
- 220 participants (estimated)
Arms
- Arm: Psychological Support Group
- Arm: Group Without Psychological Support
Primary Outcome Measure
Longitudinal study of Psycho-Emotional Distress Scores [ Time Frame: Up to 9 months ]
Central Contacts
- Marie-Charlotte Villy, MD01.42.49.47.98
- Jérôme Lambert, MD PhD0142499742
Related Studies
- Collection of Serum and Tissue Samples From Patients With Biopsy-Proved or Suspected Malignant DiseaseRecruiting · National Cancer Institute (NCI) · Bethesda, Maryland
- Collection of Tissue Specimens From Patients With Solid Tumors or Blood Disorders and Their HLA-Compatible Family MembersEnrolling By Invitation · National Heart, Lung, and Blood Institute (NHLBI) · Bethesda, Maryland
- Novel Serum Markers for Monitoring Response to Anti-Cancer TherapyRecruiting · Stanford University · Stanford, California
- Barrett's Esophagus Related Neoplasia (BERN) ProjectRecruiting · Midwest Biomedical Research Foundation · Kansas City, Missouri