Psychological Factors Influencing Cancer Post-traumatic Growth

Официальное название

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

Обзор

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.

Вмешательства

• Другое Interviews with a psychologist/psychiatrist
  All patients with a high score (≥11) on the HADS anxiety and/or depressive symptoms scale and who are not already receiving known psychological treatment or treatment mentioned in the file will be contacted by telephone by the investigator or a qualified person designated by him/her in order to conduct a telephone interview with the patient and refer him/her to a psychologist or psychiatrist if necessary. The number and percentage of consultations with a psychologist or psychiatrist following th

Первичные конечные точки

• Post-traumatic growth [Срок оценки: T1 : At the beginning of chemotherapy]
• Post-traumatic growth [Срок оценки: T2 : Up to 3 weeks after the end of chemotherapy]
• Post-traumatic growth [Срок оценки: T3 : 6 months after the end of chemotherapy protocol]

Вторичные конечные точки (12)

• Satisfaction of supportive care needs [Срок оценки: T1 : At the beginning of chemotherapy]
• Satisfaction of supportive care needs [Срок оценки: T2 : Up to 3 weeks after the end of chemotherapy]
• Satisfaction of supportive care needs [Срок оценки: T3 : 6 months after the end of chemotherapy protocol]
• Emotional competence [Срок оценки: T1 : At the beginning of chemotherapy]
• Emotional competence [Срок оценки: T2 : Up to 3 weeks after the end of chemotherapy]
• Emotional competence [Срок оценки: T3 : 6 months after the end of chemotherapy protocol]
• Anxiety and depression symptoms [Срок оценки: T1 : At the beginning of chemotherapy]
• Anxiety and depression symptoms [Срок оценки: T2 : Up to 3 weeks after the end of chemotherapy]
• Anxiety and depression symptoms [Срок оценки: T3 : 6 months after the end of chemotherapy protocol]
• Psychological flexibility [Срок оценки: T1 : At the beginning of chemotherapy]
• Psychological flexibility [Срок оценки: T2 : Up to 3 weeks after the end of chemotherapy]
• Psychological flexibility [Срок оценки: T3 : 6 months after the end of chemotherapy protocol]

Критерии участия

Критерии включения

• 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

Критерии исключения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Не применимо

Модель

Одна группа

Маскирование

Открытое

Основная цель

Поддерживающая терапия

Центры проведения

Франция · 1 центр

• Centre Hospitalier de Valenciennes — Valenciennes

Идентификаторы

NCT: NCT06278558 · 2023-02-01

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗