Evaluation of the Added Value of Logotherapy in the Psychological Support of Patients With Primary Breast Cancer

Официальное название

Randomized, Comparative Study to Evaluate the Added Value of Logotherapy in the Psychological Support of Patients With Primary Breast Cancer

Обзор

The diagnosis of breast cancer in a woman can cause major psychological trauma with many destructive effects in all areas of life. Dealing with this profound distress is often difficult, sometimes poorly defined between different professionals (psychiatrists, psychologists, psychotherapists, proponents of alternative therapies), leading to highly variable and difficult-to-measure results. Since the first French cancer plan (2003/2007), facilities offering cancer care have been legally required to have a notification and support system in place. This consists of offering patients a range of supportive care throughout their cancer treatment (psychotherapy, physical activities, dietetics, pain management, etc.). In recent years, logotherapy has been offered as part of psychological care. Logotherapy is a form of psychotherapy based on meaning, which has been offered for many years and aims to help patients create or discover meaning in their lives. Meaning serves as motivation to continue living despite illness by placing this ordeal in the context of existence. Suffering can thus be transformed into opportunity. The use of logotherapy gives the suffering person the ability to take an active part in their treatment and helps them to mobilize their personal resources to keep the disease at bay, stabilize it, or cure it. Several studies conducted on women with breast or gynecological cancer have shown that logotherapy can reduce the symptoms of traumatic stress and increase their ability to find meaning in their lives. However, these studies have certain limitations because they are not randomized. In order to evaluate the short- and medium-term benefits of logotherapy in patients diagnosed with primary breast cancer, we propose a prospective, comparative, randomized study.

Вмешательства

• Другое Support to the patient including logotherapy
  Logotherapy consists of four individual sessions conducted by a nurse who is specialized and certified in logotherapy, at a rate of one session every two weeks, lasting approximately 60 minutes.
• Другое Support to the patient without logotherapy
  Supportive care offered as part of the patient notification process following the diagnosis of breast cancer.

Первичные конечные точки

• Anxiety [Срок оценки: 10 weeks]
• Depression [Срок оценки: 10 weeks]

Вторичные конечные точки (6)

• Anxiety and depression [Срок оценки: Baseline, 10 weeks, 6 months and 9 months]
• Perceived stress [Срок оценки: Baseline, 10 weeks, 6 months and 9 months]
• Quality of life assessment [Срок оценки: Baseline, 10 weeks, 6 months and 9 months]
• Consultations of psychotherapists [Срок оценки: Over 9 months]
• Anxyolitic treatments consumption [Срок оценки: 10 weeks, 6 months and 9 months]
• Anti-depressant treatments consumption [Срок оценки: 10 weeks, 6 months and 9 months]

Критерии участия

Критерии включения

Female patient:

• With a first diagnosis of histologically proven breast cancer,
• Affiliated to a health insurance scheme,
• Having been informed and having given her free and informed consent prior to any procedure specific to the study.

Критерии исключения

Female patient:

• Unable to understand the study and to answer to the questionnaires
• With an indication for neoadjuvant chemotherapy
• Undergoing antidepressant treatment at the time of diagnosis
• Presenting with alcohol or drug addiction at the time of diagnosis
• Protected: adult under guardianship, curatorship, or other legal protection, deprived of liberty by judicial or administrative decision.
• Pregnant, breastfeeding, or in labor.

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

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Поддерживающая терапия

Центры проведения

Франция · 1 центр

• Clinique du Fief de Grimoire — Poitiers

Идентификаторы

NCT: NCT07267572 · AELO · 2024-A02252-45

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗