SupporTive Care At Home Research (STAHR): a Cluster Non-randomized Controlled Trial for Patients With Advanced Cancer
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 396
- 试验地点
- 7
- 主要终点
- Unplanned hospitalization
研究概览
简要总结
To test the effects of home-based care on unplanned hospitalization within 6 months among advanced cancer patients with decreased performance status. Home-based care includes education for patients and their family caregivers, home visits by specialized home-based medical staff, and regular status check-ups.
详细描述
This study is a cluster, non-randomized controlled trial to test the effects of home-based care on unplanned hospitalization in 6 months among advanced cancer patients with decreased performance status. Home-based care includes education for patients and their family caregivers, home visits by specialized home-based medical staff, and regular status check-up. We are recruiting the study participants from 6 institutions, aiming for 396 cancer patients.
Participants for the intervention group will be recruited from Seoul National University Hospital, Chung-ang University Hospital, and Dongguk University Ilsan Hospital. Participants for the control group will be recruited from Kyung Hee University Medical Center, CHA Bundang Medical Center, and Seoul National University Bundang Hospital.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 19 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Both the patient and their family caregiver must meet the criteria to be considered for this research.
- •A person who has an advanced-stage solid cancer diagnosis (ICD-10 code C00-C70); A person who is receiving or planning to receive cancer treatment
- •A person who meets one of the following conditions
- •Has been evaluated as having ECOG performance status 2
- •Has been evaluated as having ECOG performance status 1 and is over 70 years of age
- •A person who wishes to stay at home
- •A person whose family caregiver resides at home
- •A person who wishes to participate in the research
- •Family Caregiver
- •A family* member of the patient
- •* Family: refers to the patient's spouse (including a common-law partner), descendants and their spouses up to the second degree, siblings and their spouses, and relatives and their spouses up to the eighth degree.
- •A person who meets one of the following conditions:
- •Lives with the patient (patient's household member)
- •Does not live with the patient, but visits the patient's home more than three times a week
- •A person who wants the patient to stay at home
- •A person who can communicate easily with medical staff
- •A person who wishes to participate in the research
排除标准
- •If either the patient or the family caregiver meets any one of these criteria, they are excluded from the study.
- •A person who cannot speak, hear, or read Korean
- •A person who is judged by a medical doctor to be unable to take part in this research due to extremely poor health
- •A person residing outside the range that can be visited by the respective medical institution (the conditions for distance are to be specified by each medical institution)*
- •* This condition is not applicable for the control group.
- •A person who has used hospital- or home-type hospice and palliative care services
- •A person who is under the age of 19
- •Family Caregiver
- •A person who cannot speak, hear, or read Korean
- •A person who is judged by a medical doctor to be unable to take part in this research due to extremely poor health
- •A person under the age of 19
结局指标
主要结局
Unplanned hospitalization
时间窗: within 6 months following enrollment
1. admission to the enrolled hospital to treat unexpected symptoms or medical conditions (not including planned admission for chemotherapy or admission for planned surgery or intervention) 2. admission to a hospital other than the enrolled hospital 3. admission to a nursing hospital for a duration of less than 4 weeks.
次要结局
- Quality of life of patient - ESAS(within 6 months following enrollment)
- Quality of life of patient - EQ-5D(within 6 months following enrollment)
- Care burden of family caregiver(within 6 months following enrollment)
- Satisfaction with services (family caregiver)(within 6 months following enrollment)
- Expenses(within 6 months following enrollment)
- Hospitalization(within 6 months following enrollment)
- Patient end-of-life care: ventilator treatment(within 1 month before death)
- Depressive symptom of family caregiver(within 6 months following enrollment)
- Patient end-of-life care: an advance directive(within 1 month before death)
- Depressive symptom of patient(within 6 months following enrollment)
- Quality of life of family caregiver(within 6 months following enrollment)
- Patient medical utilization(within 6 months following enrollment)
- ER visits(within 6 months following enrollment)
- Healthcare use(within 6 months following enrollment)
- Caring competency of family caregiver(within 6 months following enrollment)
- Patient end-of-life care: ICU admission(within 1 month before death)
- Satisfaction with services (patient)(within 6 months following enrollment)
研究者
BeLong Cho
Professor
Seoul National University Hospital