CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 110 enrolled
Drug / intervention
Early palliative care integrationbehavioral
Likely dose
Not stated in record
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Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT06726317
NCT06726317N/ACompleted

The Prevalence and Associated Factors of Psychological Distress, and Effectiveness of a 'Life Situation Improving Intervention' Among Oral Cancer Patients Attending Tertiary Care Hospitals in the Colombo District

University of Colombo·interventional·Posted Dec 10, 2024·Updated Dec 10, 2024

In Brief

A clinical study evaluating Early palliative care integration for Oral Cancer and 3 related conditions. Completed, enrolled 110 participants across 4 sites.

Detailed Summary

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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesSri Lanka
Collaborators--

Timeline

N/ACompletedFinished
20192020202120222023202420252026
First PostedDec 10, 2024
Enrollment StartDec 15, 2018
Primary CompletionSep 22, 2020
TodayJul 2, 2026
Enrollment to primary: 1.8 yearsPosted 1.6 years ago

Interventions

Early palliative care integrationbehavioral

The early palliative care intervention package was developed following the guidelines provided by the UK Medical Research Council for the development of complex interventions. The early palliative care intervention for patients with oral cancer had six components: 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 package was formulated by triangulating literature review findings and several independent studies: a case-control study; in-depth interviews with experts in the field of oncology and palliative care in Sri Lanka; key-informant interviews with patients with oral cancer and their caregivers; and an observation study at the National Cancer Institute Sri Lanka- Apeksha Hospital). The intervention package was finalized through a