Change of Quality of Life, Treatment Decision and Utilization of Health Care Depending on the Use of Palliative Care in Adult and Pediatric Patients With Advanced Stage of Cancer: a Prospective Cohort Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 444
- 试验地点
- 15
- 主要终点
- Change from baseline Overall QOL of EORTC QLQ - Core 15 at 6 months items
研究概览
简要总结
This study evaluates the change of quality of life, treatment decision and utilization of health care depending on the use of palliative care in advanced cancer patients by a prospective cohort study. Participants will be separated into different groups by their intentions for using palliative care. Every participant will carry out the questionnaire per 3 months. This cohort study will be ended a year after each participant enrolls. However, if the participant didn't survive during this study, the caregivers will be asked to fill out additional questionnaire after 3 months of the death.
详细描述
Patients with advanced cancer report physical, emotional, social and economic problems that may be due to the cancer itself or its treatment. Previous studies have shown the benefit of early palliative care in oncology. However, many Korean patients tend to start palliative care late even in general hospital. Because of the late start of palliative care, the burden of medical expenses increases, on the other hand, the quality of life of terminally ill patients decrease.
In this study, the use of palliative care in advanced cancer patients will be evaluated by a prospective cohort study. The goals of this study are as follow:
First, the clinical, psycho-social, and cognitive factors affecting quality of life, decision making, and hospital utilization (palliative medical team medical treatment, hospice and medical care) of patients with advanced stage cancer will be investigated.
Second, this study will explore the effects of age-specific characteristics on quality of life and care.
Third, an index, which reflects age-specific characteristics and predicts the time and content of terminal care will be developed. Improvements on the quality of life and care of patients with advanced stage of cancer or metastatic cancer are expected to establish effective terminal care strategies through this study.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •19 years of age or older and diagnosed as cancer older than 19 years of age
- •Stage 4 of advanced Breast Cancer, Colon cancer, gastric cancer, pancreatobiliary cancer, lung cancer, Liver Cancer or Malignant hematologic neoplasm
- •Patients under one of the following status : 1) under the standard chemotherapy, 2) interrupted state of standard chemotherapy, 3) under the additional chemotherapy after standard chemotherapy, 4) terminating state of any chemotherapy yet expected to be survive more than 6 months.
- •who understand the purpose and method of the study and sign with informed consent form.
排除标准
- •who are unable to participate due to poor cognitive capacity
- •who cannot read or understand Korean language
- •who are unable to complete surveys due to physical conditions
- •[Pediatric Patients]
- •Inclusion Criteria:
- •Who was diagnosed as pediatric cancer between 0-18 years of age.
- •Younger than 30 years of age
- •Patients under one of the following status : 1)recurrence after 2nd standard chemotherapy or without remission in leukemia, 2) recurrence after stem cell transplantation, 3) diagnosed as the cancer of poor prognosis : ATRT, glioblastoma multiforme, brainstem glioma etc.
- •Patients or their proxy understand the purpose and method of the study and sign with informed consent form.
- •Exclusion Criteria:
- •Parents of patient are unable to participate due to poor cognitive capacity
- •Parents of patient do not have legal responsibility or rights of the patient
- •Parents of patients cannot speak, read or understand Korean language
结局指标
主要结局
Change from baseline Overall QOL of EORTC QLQ - Core 15 at 6 months items
时间窗: Baseline, 3 months, 6 months
to measure quality of life of adult patients developed by European Organisation for Research and Treatment of Cancer for Palliative Care
次要结局
- Decision Conflict Scale(Baseline, 6 months)
- Medical cost in KRW/person/month(3 months, 6 months)
- Patients survival and Physicians Orders for Life Sustaining Treatment (POLST) documentation(Baseline, 3 months, 6 months)
- KG-7(The Korean Cancer Study Group Geriatric Score)(Baseline, 3 months, 6 months)
- Utilization of healthcare services(3 months, 6 months)
- Preference of Advance care and Palliative care(3 months, 6 months)
- Mcgill Quality of Life (MQOL)(Baseline, 3 months, 6 months)
- Patient Health Questionnaire-9(Baseline, 3 months, 6 months)
- Understanding the illness(Baseline, 3 months, 6 months)
- Self-reported Health Status(Baseline, 3 months, 6 months)
- Pediatric Quality of Life Inventory(Baseline, 3 months, 6 months)
研究者
Young Ho Yun
Clinical Professor
Seoul National University Hospital