Comprehensive Palliative Care for Cancer Patients in Vietnam

NCT05103488 | Completed

• 1 other identifier: PC-MDT
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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.

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

Outcome Measures

Primary Outcomes (1)

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

  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.

  6 weeks

Secondary Outcomes (3)

• 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

Study Arms (2)

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.

Other: Comprehensive palliative care

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.

Other: Standard of care

Interventions

Comprehensive palliative care OTHER

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.

Intervention

Standard of care 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.

Control

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Vietnam Palliative Health Care Society: lead
• University Medical Center Ho Chi Minh City (UMC): collaborator

Study Sites (1)

Vietnam Palliative Health Care Society

Ho Chi Minh City, 70000, Vietnam

Location

MeSH Terms

Interventions

Standard of Care

Intervention Hierarchy (Ancestors)

Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation

Study Officials

• Quynh Truong, SW, MPH

  Vietnam Palliative Health Care Society

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 2, 2021
• First Posted: November 2, 2021
• Study Start: May 7, 2020
• Primary Completion: April 30, 2021
• Study Completion: April 30, 2021
• Last Updated: November 2, 2021

Record last verified: 2021-10

Data Sharing

• IPD Sharing: Will not share

Locations

VN (1)