Clinical trial NCT05103488: Comprehensive Palliative Care for Cancer Patients in Vietnam
Official title: Effectiveness of Comprehensive Palliative Care on Improving Quality of Life and Psychological Distress Among Cancer Patients in Vietnam - a Randomized Control Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Advanced Cancer
Psychological Distress
Quality of Life
Keywords: holistic palliative care
supportive care
psychosocial support
interdisciplinary approach
social work
palliative care
advanced cancer
quality of life
Vietnam
Lead sponsor: Vietnam Palliative Health Care Society
Sponsor class: OTHER
Collaborators: name: University Medical Center Ho Chi Minh City (UMC)
First posted: 2021-11-02
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: 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.

Detailed description: 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.

Randomization and blinding Block randomization. Before the first participant enrolled, a researcher created a block randomization list (block size = 4) by using Sealed Envelope (Sealed Envelope Ltd, 2020). Each week, an independent research coordinator not involved in the treatment assigned patients who finished their consent forms into groups based on the order of the list. The study is an open-label study due to the type of intervention.

Data collection. Data was collected through face-to-face interviews by 5 nurses who were not in patients' care team. Training was provided to all the data collectors to reduced bias and ensure quality of the data. It is required to conduct the questionnaire with a reasonable amount of time that did not exhaust patients. The interview schedule was arranged by the trial coordinator, then email to the interviewers. Data was collected as soon as a patient enrolled to the study. Then data collection was repeated at 3rd week and 6th week.

Intervention arm 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 clinical palliative care team in the CPC intervention is a comprehensive group of multidisciplinary professionals who share a common goal to help patients manage their life-limiting illnesses. The multidisciplinary team arrange a team meeting once a week to discuss all the cases. The team member will share their concerns and collaborate in care planning.

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. All assessments for patients' psychosocial and spiritual distresses were conducted in the first week after enrolling to CPC. Patients can be discharged in different time based on their treatment and health conditions. CPC intervention is continued after patients are discharge though telephone calls. Due to COVID pandemic, home visit is not appropriate.

Control arm 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.

Sample size calculation Based on a study by Margareta Brännström et al. (Brännström \& Boman, 2014), we estimated that a sample size of at least 41 participants in each group was needed to detect a mean difference of 8.60 in EQ-5D-5L score with a standard deviation of 13.70, and at 5% significance level, power of 80%. Due to the advanced stage of illness in the patients we estimated an attrition rate of 20% which meant that at least 50 participants were needed in each group.

Analysis We described and compared baseline data between the intervention and the control group using parametric and non-parametric tests as appropriate. We used t-test to compare the primary outcome, change in EQ-5D-5L after six weeks, between groups. Analyses of secondary outcomes included comparing domain of VietPOS, psychological distress and caregiver burden between groups. We used multiple imputation to deal with missing data. The alpha level for all statistical analyses was set at two-sided 0.05. All analyses were performed using R software.

Ethics approval Ethics approval for the study was gained from the ethics committee of University Medical Center at Ho Chi Minh city (Ref. 33/GCN-HĐĐĐ), obtained on 15/07/2020. The study protocol is retrospectively registered with ClinicalTrials.gov (NCT01165034). The delayed registration was due to the lack of human resource and technical support during the COVID-19 epidemics in Ho Chi Minh city, Vietnam.

Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

* 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

Primary outcomes:
measure: Change of Quality of Life From Baseline to Week 6 by assessing The 5-level EQ-5D (EQ5D-5L)
timeFrame: 6 weeks
Secondary outcomes:
measure: Change of Symptom Burden From Baseline to Week 6 by assessing the Vietnamese Palliative Outcome Scale (VietPOS)
timeFrame: 6 weeks
measure: Change of Psychological distress From Baseline to Week 6 using Hospital Anxiety and Depression Scale (HADS)
timeFrame: 6 weeks
measure: Change of Caregiver burden From Baseline to Week 4 by Zarit Burden Interview (ZBI)
timeFrame: 6 weeks
Other outcomes:
Locations:
city: Ho Chi Minh City
country: Vietnam
facility: Vietnam Palliative Health Care Society
Study officials:
affiliation: Vietnam Palliative Health Care Society
name: Quynh Truong, SW, MPH
role: PRINCIPAL_INVESTIGATOR
References: