Randomized, Comparative Study to Evaluate the Added Value of Logotherapy in the Psychological Support of Patients With Primary Breast Cancer
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 66
- 试验地点
- 2
- 主要终点
- Anxiety
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 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
- Female
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
结局指标
主要结局
Anxiety
时间窗: 10 weeks
Anxiety score of the Hospital Anxiety and Depression Scale (HADS) score. The HADS is a validated self-administered questionnaire consisting of 14 items allowing patients to assess their mood over the past week. It is composed of two parts (anxiety and depression) The result ranges from 0 to 21.
Depression
时间窗: 10 weeks
Depression score of the HADS. This score will be analysed on a second step (two-step hierarchical sequential analysis) only if a significative difference is observable on the first step (anxiety).
次要结局
- Anxiety and depression(Baseline, 10 weeks, 6 months and 9 months)
- Perceived stress(Baseline, 10 weeks, 6 months and 9 months)
- Quality of life assessment(Baseline, 10 weeks, 6 months and 9 months)
- Consultations of psychotherapists(Over 9 months)
- Anxyolitic treatments consumption(10 weeks, 6 months and 9 months)
- Anti-depressant treatments consumption(10 weeks, 6 months and 9 months)