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临床试验/NCT05103488
NCT05103488已完成不适用

Effectiveness of Comprehensive Palliative Care on Improving Quality of Life and Psychological Distress Among Cancer Patients in Vietnam - a Randomized Control Trial

Vietnam Palliative Health Care Society1 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2020年5月7日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
100
试验地点
1
主要终点
Change of Quality of Life From Baseline to Week 6 by assessing The 5-level EQ-5D (EQ5D-5L)

研究概览

简要总结

There are exponential increases in cancer incidence and mortality worldwide and in Vietnam. Cancer affects patient's quality of life, which can be improved by palliative care. In Vietnam, due to a shortage in human resources for social workers, palliative care is mainly focused on medical aspect. A new comprehensive palliative care model, that provides multidisciplinary support including psychosocial support to patients, was developed. This research's objective is to evaluate the effectiveness of comprehensive palliative care (CPC) on improving the quality of life among cancer patients at a hospital in Vietnam.

This randomized control trial is performed among 100 advanced cancer patients at University Medical Center at Ho Chi Minh city, Vietnam.The measurement tools include the Vietnamese Palliative Care Outcome Scale (VietPOS), the 5-level EQ-5D (EQ-5D-5L), Hospital Anxiety and Depression Scale (HADS) and Zarit Burden Interview (ZBI). Data collection has been conducting through face-to-face interviews three times: baseline, week 3, and week 6. Paired t-test (or Wilcoxon Rank sum test) and Student-t-test (or Mann -Whitney U test) will be used to evaluate and compare changes in quality of life and psychological distress within and between groups. Intention- to - treat analysis is used in the study.

This is the first research that study the effectiveness of a palliative care psychosocial intervention on cancer patients in Vietnam. The result can be used to advocate for multidisciplinary palliative care in Vietnam.

详细描述

Background Vietnam, a Southeast Asian country with a population of 97 million, is still facing both communicable and non-communicable conditions, in which cancer is on the rise. In a report by GLOBOCAN 2020, the number of new cancer cases were 182,563 cases with around 122,690 cancer deaths in 2020 (World Health Organization, 2020). Living and dying with cancer, patients not only cope with their long-term physical conditions but also deal with complex sufferings which significantly affect their quality of life (Arman, Rehnsfeldt et al, 2004; Cherny et al, 1994; Hui et al, 2015). Cancer patients suffer from clusters of symptoms from physical, psychosocial issues as pain (35-96%), anorexia (30-92%), depression (3-77%) (Solano, et al, 2006). A recent Vietnamese study in stage III and IV cancer patients found out that health related quality of life and general health were reported as bad and very bad in about 23% and 52% of patients, respectively. (Huyen et al., 2021) Palliative care is one of the essential components in cancer programs, along with prevention, early detection, diagnosis, and treatment to reduce the incidence, mortality from cancer, and improve the quality of life for cancer patients. (WHO, 2002). In 2006, Vietnam's MoH endorsed the very first national guideline for provision of palliative care in Vietnam (Krakauer et al., 2018). The traditional palliative care team in Vietnam consists of two main components of physician and nurse (Krakauer et al., 2018). However, surveys among those palliative care clinicians revealed that they felt more competent providing physical care than psychological, social, and spiritual care (Nguyen et al., 2014; Tsao et al., 2019) To further promote the role of social work in hospitals, the Vietnamese MoH issued Circular 43/2015/TT-BYT regulation on the required tasks and organizations of social work in hospital settings. Evidence of efficacy from palliative care social support provided by social workers is needed to advocate for more allocation of resources.

Aims and objectives The aim of this study is to evaluate the effectiveness of a multidisciplinary CPC on improving quality of life and psychological distress among advanced cancer patients at University Medical Center in Vietnam.

The first objective is to assess the effect of the multidisciplinary CPC on cancer patient's quality of life. The second objective is to assess the effect of the multidisciplinary CPC on cancer patient's psychological distress.

Methods/Design Setting CPC is an inpatient hospital based in the Palliative and Geriatrics Unit at the University of Medical Center in Ho Chi Minh city. Each year, it serves more than 2 million outpatients per day (approximately 7000 patients/day); 55,000 inpatients. The unit has 30 fixed bed capacity but could mobilize up to 20 beds from other wards when needed. The area has very limited resources for home-based palliative care and community services for hospice.

Recruitment procedure Participants are recruited among cancer patients referred to palliative care. The research coordinator sends the trial's information and an invitation to eligible patients, and to get the consent form.

研究设计

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

入排标准

年龄范围
18 Years 至 70 Years(Adult, Older Adult)
性别
All
接受健康志愿者
否

入选标准

  • •Aged from 18 to 70
  • •In their first week of hospitalization
  • •Diagnosed with stage 3 or 4 of any cancer.

排除标准

  • •Patients with HIV, current pregnancy, or cognitive problems
  • •Could not communicate,
  • •Could not speak Vietnamese,
  • •Could not provide informed consent and questionnaires.
  • •Currently receiving palliative care services from other medical institutions

研究组 & 干预措施

Intervention

Experimental

Comprehensive palliative care (CPC) is multidisciplinary inpatient care that aims to respond to patients' suffering in many aspects: physical, psychological, social, and spiritual. It is basically a standard palliative care service in Vietnam with additional psychosocial and spiritual support with a multidisciplinary approach. CPC is provided by seven doctors, 20 nurses, two social workers, a pharmacist, and a psychologist. CPC could go parallel with oncology care or be the primary care for patients.

The psychosocial and spiritual supports are mainly provided by social workers. Psychologist and religious will get involved when patient need advance care. The psychosocial intervention is individualized for each patient based on their individual situation, issues, and decision.

干预措施: Comprehensive palliative care (Other)

Control

Other

Patients who are randomized to the control group will receive the standard palliative care in Vietnam. They can assess to the same palliative care for their physical symptoms as patients in the intervention group do. They can also access psychosocial and spiritual support from the resources that available for them before entering to the study. If they request for social or financial support, their care team can reach out to the social work departments. Patients who are in need can receive mental health care from psychiatrists from the psychiatrist unit at UMC.

干预措施: Standard of care (Other)

结局指标

主要结局

Change of Quality of Life From Baseline to Week 6 by assessing The 5-level EQ-5D (EQ5D-5L)

时间窗: 6 weeks

Primary outcome is the change of quality of life after assed by the change of the total score of the 5-level EQ-5D questionnaire. The 5-level EQ-5D version was introduced by the EuroQol Group in 2009. It comprises the following five dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Each dimension has five levels: no problems, slight problems, some problems, severe problems and unable to do. Each level of answer consists of each level of score ranges from 1 to 5. Each participant will have a health status consisting of 5 digits. Using the set of weights from Vietnamese population provided from the EuroGroup, we can convert each EQ-5D health state into a single summary index value. The index value ranges from 0 to 1, higher scores meaning better health quality.

次要结局

  • Change of Symptom Burden From Baseline to Week 6 by assessing the Vietnamese Palliative Outcome Scale (VietPOS)(6 weeks)
  • Change of Psychological distress From Baseline to Week 6 using Hospital Anxiety and Depression Scale (HADS)(6 weeks)
  • Change of Caregiver burden From Baseline to Week 4 by Zarit Burden Interview (ZBI)(6 weeks)

研究者

发起方
Vietnam Palliative Health Care Society
申办方类型
Other
责任方
Sponsor

研究点 (1)

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