German Randomized Controlled Trial of the Psychotherapeutic Intervention for Advanced Cancer Patients: Managing Cancer and Living Meaningfully (CALM)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 206
- 试验地点
- 2
- 主要终点
- Beck Depression-Inventory II (BDI-II)
研究概览
简要总结
Purpose of this randomized controlled trial is to test the efficacy of the individual psychotherapeutic intervention Managing Cancer and Living Meaningfully (CALM) in a German sample of patients with advanced cancer. The interventions aim is to reduce depression and distress and support psychological well-being.
详细描述
Principal hypothesis: The manualized psychotherapeutic intervention (CALM) will result in a significantly greater reduction in depression and psychological distress compared to a non-manualized supportive psycho-oncological intervention. Secondary hypothesis: The manualized psychotherapeutic intervention (CALM) will further result in a significantly improve psychological well-being, quality of life and sense of meaning compared to a non-manualized supportive psycho-oncological intervention.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •≥18 years of age
- •Fluency in German
- •No cognitive impairment indicated in the medical record or by the attending oncologist
- •Confirmed diagnosis of solid tumors with UICC (Union Internationale Contre le Cancer) stages III/IV/ metastasized cancer (all with expected survival of 12-18 months)
- •PHQ-9 depression score >=9 or Distress thermometer score >=5
排除标准
- •Major communication difficulties (including language barriers)
- •Inability to commit to the required 3-6 psychotherapy sessions
- •A score <20 on the Short Orientation-Memory-Concentration (SOMC) test, indicating cognitive impairment unless deemed suitable at recruiter's discretion
- •A score <70 on the Karnofsky-Performance Status Scale, indicating high physical symptom burden impeding study participation
- •Being in psychotherapy
研究组 & 干预措施
Manualized CALM Intervention
干预措施: Manualized CALM intervention (Behavioral)
Non-manualized supportive intervention
干预措施: Non-manualized supportive intervention. (Behavioral)
结局指标
主要结局
Beck Depression-Inventory II (BDI-II)
时间窗: 6-months
A reliable and valid 21-item self-report instrument for evaluating the severity of depression.
Depression module of the Patient Health Questionnaire (PHQ-9)
时间窗: 6-months
A reliable and valid 9-item measure of depression.
次要结局
未报告次要终点
研究者
Anja Mehnert
Prof. Dr. Anja Mehnert
University of Leipzig