Apport d'un Accompagnement Psychologique au Cours du Parcours en oncogénétique : étude de la Trajectoire Psycho-émotionnelle Des Consultants
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 220
- 主要终点
- Longitudinal study of Psycho-Emotional Distress Scores
研究概览
简要总结
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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.
排除标准
- •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.
结局指标
主要结局
Longitudinal study of Psycho-Emotional Distress Scores
时间窗: 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).
次要结局
- 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)