QoLiCOL - Quality of Life in Colon Cancer
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 1,500
- 试验地点
- 1
- 主要终点
- QoL in colon cancer patients
研究概览
简要总结
All patients presenting at participating hospitals during the recruitment period with a newly diagnosed colon cancer, regardless of stage and planned treatment, will be eligible for inclusion. They will answer a questionnaire on health related quality of life, physical symptoms, functional impairments and socioeconomic status at diagnosis and after 12, 36 months. Clinical data including recurrence, survival, surgical treatment, oncologic result (pathology report) and adjuvant treatment will be collected from the Swedish ColoRectal Cancer Registry (SCRCR)
详细描述
QoLiCOL is an explorative, prospective, longitudinal, non-interventional, international, multicenter study of health-related quality of life, physical symptoms, functional impairments and socioeconomic burden in colon cancer patients. All patients presenting at participating hospitals during the recruitment period with a newly diagnosed rectal cancer, regardless of stage and planned treatment, will be eligible for inclusion. Patients will be followed for 3 years. They will be asked to answer questionnaires at three different time points during follow-up: at diagnosis and after 12 and 36 months. Clinical data, including recurrence, surgical treatment, oncologic result (pathology report) and adjuvant treatment will be collected from the national quality registry for rectal cancer in Denmark and Sweden. As these registries differ in some areas between the countries, additional data will be collected through short CRF:s.
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
- •Colon cancer newly diagnosed.
- •Planned treatment presented
排除标准
- •No Colon cancer diagnosis,
- •below 18 years of age,
- •no informed consent or withdrawn informed consent.
结局指标
主要结局
QoL in colon cancer patients
时间窗: 3 years
The primary end-point is to describe QoL, symptoms and functional impairments in an unselected population of colon cancer patients
次要结局
- Generate basic descriptive data of the patient population, such as demography, socioeconomic data, disease stage at diagnosis, type of treatment, recurrence and survival(3 years)
- Compare differences in QoL between patients with different tumour levels(3 years)
- Analyse how clinical factors like oncologic result of operation, morbidity, recurrence and survival influence QoL(3 years)
- Identify areas of improvement in treatment and patient care(3 years)
- Enable initiation interventional studies when appropriate(3 years)
- Detect differences in QoL in patients over time after colon cancer treatment(3 years)
- Evaluate the effect of complications after colon cancer surgery on the patients socioeconomic situation(3 years)
- Evaluate the effect of coping strategies on QoL after initiated treatment(3 years)
- Describe patient expectations at diagnosis of colon cancer(3 years)
- Identify differences in QoL between patients in different groups regarding gender, age and education level(3 years)
- Analyse health economy aspects of QoL and morbidity in the patient population(3 years)
研究者
Eva Angenete
Principal Investigator
Sahlgrenska University Hospital, Sweden