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临床试验/NCT01885637
NCT01885637已完成不适用

DOMUS: A Randomized Controlled Clinical Trial of Accelerated Transition From Oncological Treatment to Continuing Palliative Care at Home

Rigshospitalet, Denmark1 个研究点 分布在 1 个国家目标入组 340 人开始时间: 2013年6月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
340
试验地点
1
主要终点
Place of care and death

研究概览

简要总结

Danish studies have shown that the majority of palliative cancer patients wish to be cared for and spend the rest of their lives at home. Nevertheless > 50% of palliative cancer patients die in acute hospitals and these figures are found in countries with a highly developed palliative care service as well. Some studies have suggested that, among other causes, delays in the discharge process represent a significant obstacle for achieving care and treatment, and ultimately death at home. Therefore, this randomized controlled trial (RCT) aims at investigating an accelerated transition program from oncological treatment to continuous specialized palliative care at home for patients with incurable cancer. The primary objective of the study is to investigate whether an accelerated transition from oncology care to palliative home care significantly increases home care and death. The secondary objectives are to investigate whether the intervention improves symptom control and quality of life, increases survival, affects health care expenses, improves caregiver quality of life and burden, dyadic coping and grief outcomes. The study will take place in the departments of oncology at Rigshospitalet, where palliative cancer patients will enter the intervention or usual care arms. The intervention is an accelerated transition program, which consists of planning palliative home care and if needed optimization of facilities at home, and a transfer to home care within 5 days of informed consent. On day 1 at home the patient, informal caregiver, nurse, representatives of the specialized palliative care team and if possible the general practitioner and project psychologist meet to organize home care. A dyadic psychological intervention is offered to patients and their informal caregiver during specialized palliative care at home and to bereaved caregivers. The control group will be treated according to the usual principles, but if inadequate palliative care is observed in this group, the study group is obliged to involve responsible professionals. Both groups will be followed by assessments of the patient and the caregiver for up to 6 months and the caregivers 19 month after the patient's death.

详细描述

The trial is a controlled, randomized clinical trial in which 340 in- and outpatients in the Department of Oncology, at Rigshospitalet (Copenhagen University Hospital), are randomly assigned to either an accelerated transition process from oncological treatment to continuing specialised palliative care (SPC) at home plus standard care or standard care alone.

Patients are randomized immediately after their consent and will be discharged within a maximum of 5 working days from randomization. If these timelines are exceeded due to practical issues, the patient can participate in the trial if he/she completes a new base-line questionnaire (Quality of life questionnaire - Core (EORTC-QLQ-C30), Edmonton Symptom Assessment System (revised version) (ESAS-r), Hospital Anxiety and Depression Scale (HADS), Symptoms priority list, Symptom Checklist-92 (SCL-92), Medical Outcomes Study Social Support Survey (mMOS-SS), Dyadic Coping Inventory (DCI)and Relationship ladder, and still meets the inclusion criteria.

Data collection from patients and informal caregivers:

Patients are identified, informed about the study and consenting patients and their informal caregivers complete questionnaires (baseline), after which patients are randomized to either the intervention or the control group. The intervention group will be assigned a specialised palliative care team (SPT) no later than 5 days after randomization. The control group will continue their current treatment. Two weeks after baseline, patients and caregivers complete questionnaires for the 2-week follow-up. Likewise, the follow-up at 4 and 8-weeks consists of questionnaires completed by patients and caregivers. Six months after baseline, the patient's vital status is retrieved. If the patient is still alive questionnaires are sent to the patient and caregiver.

In case of admissions of the patients in both groups, data regarding causes of admission are retrieved from medical records.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Other
盲法
None

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Adult (at least 18 year old) cancer patients connected to the Department of Oncology, Copenhagen University Hospital
  • Patients who want to spend as much time as possible in their own homes supported by an SPT
  • Patients with incurable cancer
  • Patients with no or limited antineoplastic treatment options or patients who resign antineoplastic treatment
  • Patients living in the Capital Region
  • Written informed consent

排除标准

  • Patients who have already been referred to an SPT
  • Hospitalized patients who are not judged capable of being discharged home
  • Patients who are admitted to other hospitals
  • Patients who do not speak Danish well enough to answer the questionnaires
  • Patients who are considered incapable of cooperating in the trial

结局指标

主要结局

Place of care and death

时间窗: Up to 4.5 years

To investigate whether the transition process and SPC at home in patients with incurable cancer results in more patients in accordance with his/her own request obtains treatment, care, and death in their own homes.

次要结局

  • HRQL(Up to 4.5 years)
  • Healthcare services and informal care(Up to 4.5 years)
  • Cooperation and quality of the process(Up to 4.5 years)
  • Caregiver: Use of health services(Up to 4.5 years)
  • Caregiver burden(Up to 4.5 years)
  • Caregiver: The psychological intervention(Up to 4.5 years)
  • Use of medicine(Up to 4.5 years)
  • Caregiver: anxiety and depression(Up to 4.5 years)
  • Anxiety and depression(Up to 4.5 years)
  • Survival time(Up to 4.5 years)
  • Caregiver: prolonged grief(Up to 4.5 years)
  • Dyadic coping(Up to 4.5 years)
  • Preference for place of treatment and care(Up to 4.5 years)
  • Caregiver Grief(Up to 4.5 years)
  • Hospital admissions(Up to 4.5 years)
  • Caregiver: HRQoL(Up to 4.5 years)
  • Caregiver: telomere degradation(Up to 4.5 years)
  • Caregiver health behavior(Up to 4.5 years)
  • Non-participation(up to 4.5 years)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Per Sjogren

Professor, M.D., Dr. Med. Sci

Rigshospitalet, Denmark

研究点 (1)

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