Quality of Life in RECTal Cancer - A Study Within the Scandinavian Surgical Outcomes Research Group
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
- To describe QoL, symptoms and functional impairments in an unselected population of rectal cancer patients
研究概览
简要总结
Rectal cancer is a common type of cancer occuring more frequently in men but also common in women. Almost 60% of the patients survive 5-years and the treatment has been continuously developed in the last three decades. The aim of the QoLiRECT study is to increase the knowledge about symptoms, functional impairments, quality of life (QoL) and psychological and socioeconomic burden in an unselected population of rectal cancer patients.
详细描述
Rectal cancer is more frequent in men than in women and is relatively uncommon before the age of 50. The prognosis for rectal cancer has improved over the last decades2. Almost 60% of all patients survive more than five years, and because of advances in early detection and treatment, this number is expected to increase in the future1. Treatment of rectal cancer varies depending on the stage of the disease at diagnosis. For some patients, operation is the only treatment. For others, surgery is combined with radiotherapy, chemotherapy or both. The two most common operative procedures are the sphincter-preserving anterior resection (AR) and the abdominoperineal resection (APR) - the latter results in a permanent colostomy. Patients with generalised disease at diagnosis receive palliative treatment, which may include chemotherapy and radiotherapy as well as surgery.
Rectal cancer comes with a high risk of local recurrence, i.e. return of the tumour within the pelvis after a presumed curative resection. Local recurrence is difficult to treat and often very painful and distressing for the patient. Some local recurrences will be candidates for second line surgery, as is also true for some distant metastases.
The aim of the QoLiRECT study is to increase the knowledge about symptoms, functional impairments, quality of life (QoL) and psychological and socioeconomic burden in an unselected population of rectal cancer patients. Symptoms such as incontinence, pain, fatigue and impaired sexual function3 are common with this disease. Bodily changes, caused by the treatment or the disease itself, may lead to functional impairments and psychological, social, emotional and economical restraints. Conventional outcome measures such as morbidity and survival reveal little about these things.
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
- •All patients presenting at the participating hospitals with newly diagnosed rectal cancer, regardless of stage at diagnosis and plans for treatment, will be eligible for inclusion.
排除标准
- •Age below 18 years at diagnosis.
- •No informed consent received or withdrawal of informed consent.
结局指标
主要结局
To describe QoL, symptoms and functional impairments in an unselected population of rectal cancer patients
时间窗: At diagnosis
It will be evaluated at diagnosis, , i.e. at presentation of a plan for the treatment, at 12 months after start of the treatment, regardless of which, at 24 months after start of the treatment and at 60 months after start of the treatment
次要结局
- To identify symptoms and functional impairments and other risk factors that have great impact on QoL(At diagnosis)
- To explore potential differences in QoL, symptoms and functional impairments between subgroups of the population(At diagnosis)
- To identify patient and environmental factors with an impact on QoL(At diagnosis)
- To analyse how clinical factors like oncologic result of operation, morbidity, recurrence and survival influence QoL(At 12 months after start of the treatment)
- To initiate interventional studies when appropriate(12 months)
- To explore the presence and impact of intrusive thoughts on QoL(At 12 months)
- To generate basic descriptive data of the rectal cancer patient population: demography, socioeconomic data, disease stage at diagnosis, fashion of treatment, recurrence, survival(At diagnosis)
- To analyse health economy aspects of QoL and morbidity in the patient population(At diagnosis)
- QoL in an unselected population of rectal cancer patients(at 12 months)
研究者
Eva Angenete
M.D., Ph.D
Sahlgrenska University Hospital, Sweden