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临床试验/NCT06278558
NCT06278558招募中不适用

Study of the Psychological Factors Influencing Post-traumatic Growth During Oncological Pathway

Centre Hospitalier de Valenciennes2 个研究点 分布在 1 个国家目标入组 289 人开始时间: 2023年11月10日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
招募中
入组人数
289
试验地点
2
主要终点
Post-traumatic growth

研究概览

简要总结

The study focuses on post-traumatic growth (positive changes linked to appreciation of life, personal strengths, social relationships...) in the context of different types of cancer and with a longitudinal approach to the care pathway. The aim of the study is to better understand whether psychological variables (emotional competence, psychological flexibility, psychological distress) and patients' care satisfaction, assessed at the start of the cancer treatment pathway, can influence their post-traumatic growth at the end of the chemotherapy protocol and 6 months later.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Supportive Care
盲法
None

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Patients over 18 years of age
  • Patients in the initial phase of curative treatment for a 1st solid cancer
  • At the start of neo-adjuvant or adjuvant chemotherapy (1st course or 2nd course)
  • At less than 6 months from the initial diagnosis
  • Patient having given written consent to participate in the study

排除标准

  • Patients with a previous history of cancer
  • Patients with incurable cancer progression, recurrence or relapse
  • Metastatic, brain, hematological or skin cancer
  • Patients who have difficulty understanding written French
  • Patient psychologically or physically unable to answer questionnaires

研究组 & 干预措施

Interviews with a psychologist/psychiatrist

Experimental

Implementation of an interview with a psychologist or psychiatrist following a telephone conversation with patients with no psychological follow-up and a high HADS score (≥11), at all stages of the study (start of chemotherapy T1, end of chemotherapy T2, 6 months after the end of chemotherapy).

干预措施: Interviews with a psychologist/psychiatrist (Other)

结局指标

主要结局

Post-traumatic growth

时间窗: T3 : 6 months after the end of chemotherapy protocol

Post-traumatic growth will be assessed using a 21-item self-report questionnaire and a Likert scale ranging from 0 (Not at all) to 4 (Totally), the Posttraumatic growth inventory (PTGI), which has been revalidated in French (Dubuy et al., 2022) in 4 dimensions: new direction for life (6 items), personal abilities (6 items), spiritual change (2 items) and relationships with others (7 items).

次要结局

  • Satisfaction of supportive care needs(T3 : 6 months after the end of chemotherapy protocol)
  • Anxiety and depression symptoms(T3 : 6 months after the end of chemotherapy protocol)
  • Psychological flexibility(T3 : 6 months after the end of chemotherapy protocol)
  • Emotional competence(T3 : 6 months after the end of chemotherapy protocol)

研究者

申办方类型
Network
责任方
Sponsor

研究点 (2)

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