Quality of Life in Patients After Combined Modality Treatment of Rectal Cancer
试验速览
- 阶段
- 不适用
- 入组人数
- 167
- 试验地点
- 1
- 主要终点
- To prospectively evaluate the quality of life of patients one year after rectal cancer resection
研究概览
简要总结
The goal of this study is gathering informations about patients' quality of life after combined modality treatment of rectal cancer to evaluate how combined modality treatment for rectal cancer affects patients' quality of life. The findings of this study may provide us important information that can be used in treatment decision and to develop programs to improve quality of life of patients with rectal cancer.
详细描述
Over the last two decades, rectal cancer research has lead to better understanding of disease behaviour, resulting in more efficient treatments and higher prevalence of cancer survivors.Due to aggressive therapy, rectal cancer survivors can exhibit late sequelae of treatment, most common being impaired bowel, voiding, sexual malfunctioning and quality of life impairment. In order to determine the impact of rectal cancer and its treatment on patients' quality of life over time, this study will prospectively follow a cohort of patients at specified intervals evaluating their physical symptoms, physical and social functioning and overall quality of life.Medical and sociodemographic factors that might be predictive will be tested.
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 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •histologically verified adenocarcinoma of the rectum,
- •clinical stage II or III (IUCC TNM classification 2002);
- •no prior radiotherapy and/or chemotherapy;
- •World Health Organisation (WHO) performance status < 2;
- •age at diagnosis of 18 or older;
- •and adequate bone marrow, liver, renal and cardiac function (no history of ischemic heart disease)
- •mentally fit to complete questionnaires
排除标准
- •a history of prior malignancy other than non-melanoma skin cancer or in situ carcinoma of the cervix rendered the patient ineligible.
结局指标
主要结局
To prospectively evaluate the quality of life of patients one year after rectal cancer resection
时间窗: one year after the operation
次要结局
- To prospectively evaluate the quality of life of patients at baseline(before treatment (at baseline))
- To prospectively evaluate the quality of life of patients two years after rectal cancer resection(two years after the operation)