Psychological Distress in Colorectal Cancer Patients Following Surgery With Either HIPEC or Pelvic Exenteration
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 225
- 试验地点
- 3
- 主要终点
- Development of sleeping issues after PE or CRS+HIPEC for colorectal cancer
研究概览
简要总结
The purpose of this study is to describe type and extent of psychological distress (adverse effects) in patients undergoing surgery for colorectal cancer with peritoneal metastases and after surgery for colorectal cancer with involvement of the urinary bladder.
详细描述
After being informed about the study all patients giving written informed consent will be distributed a questionnaire asking questions on depression, anxiety, self-reported cognitive issues, sleep issues, quality of life and 'fear of cancer recurrence'. All these aspects will be investigated using validated questionnaires.
Once the investigators have the preliminary results (type and extent of psychological distress developed after CRS+HIPEC or PE) the investigators plan to conduct a workshop. In this workshop experts in different areas regarding psychological distress, project leaders, professor from the 'National Center of Late Adverse Effects after Cancer in Pelvic Organs' (Denmark) and patients will participate. With the input of experts and patients, a treatment strategy will be developed, and also an assessment will be made concerning which patients are likely to benefit from treatment by these experts, and which patients could potentially benefit from counselling by their general practitioner or via self-helping tools at home. The investigators plan to conduct this workshop autumn 2021 and start counselling spring 2022.
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
- •Patients who have undergone intended curative CRS+HIPEC for peritoneal metastases originated from colorectal cancer (HIPEC cohort) according to national Danish guidelines
- •Patients who have undergone intended curative total or anterior pelvic exenteration (PE cohort) for advanced or recurrent colorectal cancer according to national Danish guidelines
排除标准
- •Patients under 18 years
- •Patients not speaking Danish or Swedish, respectively, in Denmark and Sweden
- •Patients unable to give informed consent
- •Patients undergoing CRS+HIPEC or PE for cancers others than CRC
- •Terminally ill patients
结局指标
主要结局
Development of sleeping issues after PE or CRS+HIPEC for colorectal cancer
时间窗: PE cohort: Development and change in adverse effects 3, 6 and 12 months after surgery. HIPEC cohort: Development and change in adverse effects 3, 6, 12, 18, 24, 36, 48 and 60 months after surgery
Descriptive analysis will be done using following the questionnaire: ISI (insomnia sleep index)
Development of ´fear of cancer recurrence' after PE or CRS+HIPEC for colorectal cancer
时间窗: PE cohort: Development and change in adverse effects 3, 6 and 12 months after surgery. HIPEC cohort: Development and change in adverse effects 3, 6, 12, 18, 24, 36, 48 and 60 months after surgery
Descriptive analysis will be done using following the questionnaire: Fear of cancer recurrence - SF
Development of anxiety after PE or CRS+HIPEC for colorectal cancer
时间窗: PE cohort: Development and change in adverse effects 3, 6 and 12 months after surgery. HIPEC cohort: Development and change in adverse effects 3, 6, 12, 18, 24, 36, 48 and 60 months after surgery
Descriptive analysis will be done using the following questionnaire: GAD-7 (general anxiety disorder)
Development of depression after PE or CRS+HIPEC for colorectal cancer
时间窗: PE cohort: Development and change in adverse effects 3, 6 and 12 months after surgery. HIPEC cohort: Development and change in adverse effects 3, 6, 12, 18, 24, 36, 48 and 60 months after surgery
Descriptive analysis will be done using the following questionnaire: PHQ-9 (patient health questionnaire)
Development of cognitive dysfunction after PE or CRS+HIPEC for colorectal cancer
时间窗: PE cohort: Development and change in adverse effects 3, 6 and 12 months after surgery. HIPEC cohort: Development and change in adverse effects 3, 6, 12, 18, 24, 36, 48 and 60 months after surgery
Descriptive analysis will be done using following the questionnaire: Items regarding cognitive functioning from the EORTC item library
Development of fatigue after PE or CRS+HIPEC for colorectal cancer
时间窗: PE cohort: Development and change in adverse effects 3, 6 and 12 months after surgery. HIPEC cohort: Development and change in adverse effects 3, 6, 12, 18, 24, 36, 48 and 60 months after surgery
Descriptive analysis will be done using following the questionnaire: FACIT V4 (fatigue scale)
次要结局
- Risk factors associated with developing psychological distress(PE cohort: Development and change in adverse effects 3, 6 and 12 months after surgery. HIPEC cohort: Development and change in adverse effects 3, 6, 12, 18, 24, 36, 48 and 60 months after surgery.)