Clinical Trial Details
— Status: Completed
Administrative data
NCT number |
NCT05103488 |
Other study ID # |
PC-MDT |
Secondary ID |
|
Status |
Completed |
Phase |
N/A
|
First received |
|
Last updated |
|
Start date |
May 7, 2020 |
Est. completion date |
April 30, 2021 |
Study information
Verified date |
October 2021 |
Source |
Vietnam Palliative Health Care Society |
Contact |
n/a |
Is FDA regulated |
No |
Health authority |
|
Study type |
Interventional
|
Clinical Trial 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.
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.