Early Palliative Care for Patients with Oral Cancer in Sri Lanka

University of Colombo (UOC)

Status

Completed

Conditions

Palliative Supportive Care

Oral Cancer

Quality of Life of Patients

Psychological Distress

Treatments

Behavioral: Early palliative care integration

Study type

Interventional

Funder types

Other

Identifiers

NCT06726317

EC-18 097

Details and patient eligibility

About

The goal of this quasi experimental study is to develop and assess the effectiveness of an early palliative care intervention in patients with oral cancer in Sri Lanka. The main question it aims to answer is whether the early palliative care intervention improves the quality of life and psychological distress of patients with cancer in Sri Lanka.

The primary outcome measures were patient's quality of life and level of psychological distress If there is a comparison group: Researchers compared with a control group who received the standard care to see if the novel early palliative care intervention helped to improve the primary outcomes.

Participants in the intervention arm received the early palliative care package which consisted of 6 components including: 1) providing information, 2) addressing acute and functional issues, 3) nutritional care, 4) psychological support, 5) mindfulness therapy, and 6) coordination of the financial allowance. The intervention was delivered by the Principal Investigator and the trained Public Helath Nursing Officers.

Full description

The study took place at three tertiary care units providing oral cancer treatment in Sri Lanka: the oral and maxillofacial wards at the National Dental Hospital, Colombo (Teaching); the oral and maxillofacial wards at Colombo South (Teaching) Hospital, Karapitiya; and the onco-surgery wards at the National Cancer Institute Maharagama (Apeksha Hospital).

Participants The study participants were patients with oral cancer whose definitive diagnosis had been communicated to the patient and had psychological distress (score of ≥4 after screening with the Sinhala version of the Distress Thermometer); awaiting surgery as the first treatment modality; and married with children, including at least one family caregiver with the ability to communicate and read well in Sinhalese. Exclusion criteria were, recurrent oral cancer; a formal psychiatric diagnosis; and receiving or having received any early palliative care intervention. They were divided to 55 controls and 55 cases based on the availability of an accessible Public Health Nursing Officer.

Interventions The early palliative care package, comprising six components, was delivered in three sessions by the principal investigator (PI) and Public Health Nursing Officers.

Outcome measures The effectiveness was assessed by the level of psychological distress using the Sinhala version of the Distress Thermometer and Level of quality of life using EORTC QLQ 30 with module H&N 35 at baseline (T0), post-intervention (T1), one month (T2), and three months (T3).

Enrollment

110 patients

Sex

All

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

Definitive diagnosis communicated to the patient
Presence of psychological distress (score of ≥4 after screening with the Sinhala version of the Distress Thermometer27)
awaiting surgery as the first treatment modality
married with children, including at least one family caregiver with the ability to communicate and read well in Sinhalese.

Exclusion criteria