Longitudinal Analysis of Mental Disorders, Psychosocial Distress and Psycho-oncological Care Needs of Patients and Their Relatives Stratified by Biopsychosocial Factors (LUPE)
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 2,000
- 试验地点
- 1
- 主要终点
- Prevalence of mental disorders according to the DSM-5 (objective need for psycho-oncological support) in cancer patients and the changes over time
研究概览
简要总结
The primary objectives of this prospective observational multicenter study LUPE are to assess the prevalence of mental disorders according to the DSM-5 (objective need for psycho-oncological support), psychosocial distress, psycho-oncological care needs and utilization of psycho-oncological support services (subjective need for support) of cancer patients and their relatives during the first months of cancer survivorship stratified by biopsychosocial factors including socioeconomic status. The investigators further aim to identify moderating and mediating as well as associated factors for psychological distress and supportive care needs.
LUPE will include 2000 adult patients with solid tumor entities and one relative per patient at 4 measurement points from time of diagnosis to follow-up (+18 months) (t1: after diagnosis, t2: 6 month later, t3: 6 month later, t4: 6 month later).
The investigators aim to generate a quota sample according to socioeconomic status (SES) that is representative of the German overall population.
All participants will receive validated self-report questionnaires. Cancer patients will be interviewed using the standardized clinical interview SCID-5.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
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
- •Primary diagnosis of malignant solid tumor
- •a maximum time period after diagnosis of 4-8 weeks
- •minimum age of 18 years
- •cognitive ability to consent to study participation
排除标准
- •presence of hematological cancers
- •patients with cancer recurrence
结局指标
主要结局
Prevalence of mental disorders according to the DSM-5 (objective need for psycho-oncological support) in cancer patients and the changes over time
时间窗: after the diagnosis (up to 8 weeks) and at every follow up (Month 6, Month 12, Month 18)
SCID (Structured Clinical Interview)
Frequency and extent of psychological distress (Anxiety) (subjective psycho-oncological support needs) in cancer patients and their relatives and the changes over time
时间窗: after the diagnosis (up to 8 weeks) and at every follow up (Month 6, Month 12, Month 18)
GAD (Generalized Anxiety Disorder)
Frequency and extent of psychological distress (Depression) (subjective psycho-oncological support needs) in cancer patients and their relatives and the changes over time
时间窗: after the diagnosis (up to 8 weeks) and at every follow up (Month 6, Month 12, Month 18)
PHQ (Patient Health Questionnaire - Depression)
Use of psycho-oncological support services by patients and relatives and the changes over time
时间窗: after the diagnosis (up to 8 weeks) and at every follow up (Month 6, Month 12, Month 18)
Changes in Quality of Life and the changes over time
时间窗: after the diagnosis (up to 8 weeks) and at every follow up (Month 6, Month 12, Month 18)
EORTC (European Organisation for Research and Treatment of Cancer - Quality of life)
次要结局
- Protective factors and stress-increasing risk factors within the dyad of relatives and the changes over time(after the diagnosis (up to 8 weeks) and at every follow up (Month 6, Month 12, Month 18))
研究者
Anja Mehnert
Prof
University of Leipzig