Psychological Support and Psycho-Emotional Trajectories in Cancer Genetics. (PsyOncoGen)
Apport d'un Accompagnement Psychologique au Cours du Parcours en oncogénétique : étude de la Trajectoire Psycho-émotionnelle Des Consultants
연구 개요
상태
상태
정황
정황
개입 / 치료
개입 / 치료
- 다른: Patients undergoing their first cancer genetic testing consultation who choose to utilise the clinical psychological support offered by the unit
- 다른: Patients undergoing their first cancer genetic testing consultation who choose to follow the care pathway without utilising the systematically offered clinical psychological support.
연구 유형
연구 유형
등록 (추정된)
등록
연락처 및 위치
연구 연락처
연구 연락처
- 이름: Jérôme Lambert, MD PhD
- 전화번호: +33 0142499742
- 이메일: jerome.lambert@u-paris.fr
연구 연락처 백업
- 이름: Marie-Charlotte Villy, MD
- 전화번호: +33 01.42.49.47.98
- 이메일: marie-charlotte.villy@aphp.fr
참여기준
자격 기준
자격 기준
공부할 수 있는 나이
- 성인
- 고령자
건강한 자원 봉사자를 받아들입니다
샘플링 방법
연구 인구
설명
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.
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
그룹/코호트 수
코호트 및 개입
그룹/코호트그룹/코호트 |
개입 / 치료개입 / 치료 |
|---|---|
|
Psychological Support Group
|
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.
|
|
Group Without 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.
|
연구는 무엇을 측정합니까?
주요 결과 측정
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Longitudinal study of Psycho-Emotional Distress Scores
기간: 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). |
Up to 9 months
|
2차 결과 측정
2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Evolution of Psycho-Emotional Distress Post-Disclosure.
기간: 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). |
Up to 9 months
|
|
Specific Hereditary Cancer Psychosocial Concerns.
기간: 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). |
Up to 9 months
|
|
Interrelations and variations of Emotional Distress and Psychosocial Concerns (HADS & PAHC-French).
기간: 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). |
Up to 9 months
|
|
Clinical Psychological Trajectories and Psychological Support Adherence
기간: 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. |
Up to 9 months
|
공동 작업자 및 조사자
연구 기록 날짜
연구 주요 날짜
연구 시작 (추정된)
연구 시작
기본 완료 (추정된)
기본 완료
연구 완료 (추정된)
연구 완료
연구 등록 날짜
최초 제출
최초 제출
QC 기준을 충족하는 최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (실제)
처음 게시됨
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
마지막 업데이트 게시됨
QC 기준을 충족하는 마지막 업데이트 제출
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
마지막으로 확인됨
추가 정보
이 연구와 관련된 용어
추가 관련 MeSH 약관
기타 연구 ID 번호
기타 연구 ID 번호
- APHP260600
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
미국 FDA 규제 기기 제품 연구
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