Early Palliative Care for Patients with Oral Cancer in Sri Lanka

December 9, 2024 updated by: Nadisha Ratnasekera, University of Colombo

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

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 Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed 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).

Study Type

Interventional

Enrollment (Actual)

110

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Sri Lanka
    • Southern
      • Galle, Southern, Sri Lanka
        • Karapitiya Teaching Hospital
    • Western
      • Colombo, Western, Sri Lanka, 0007
        • National Dental Hospital
      • Colombo, Western, Sri Lanka
        • Apeksha Hospital
      • Colombo, Western, Sri Lanka
        • Colombo South (Teaching) Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

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:

  • Recurrent oral cancer
  • A formal psychiatric diagnosis
  • Receiving or having received any early palliative care intervention.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Intervention group receiving the novel early palliative care package
This group received the novel early palliative care intervention package
Behavioral: Early palliative care integration
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
Other Names:
  • Supportive care
  • Psycho-oncology care
No Intervention: Control group
This group received only the existing standard care in the health system and did not receive any special intervention through this study

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Patient's quality of life
Time Frame: This outcome measure was collected at four-time points: at enrollment, immediately after delivering the intervention package, 1 month after and three months after the intervention.
Quality of life was measured using the Sinhala version of the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (version C30) -EORTC QLQ 30. This tool was translated and validated to Sri Lanka through a large-scale multi-centre study. This tool measured quality of life in three sub dimensions-Global Health Status, Functional Scale and Symptom Scale. a high score in Global Health Status denoted a high quality of life, a high score for Functional Scale meant healthy level of functioning and a high score in Symptom Scale represented high level of problems
This outcome measure was collected at four-time points: at enrollment, immediately after delivering the intervention package, 1 month after and three months after the intervention.
Patient's level of psychological distress
Time Frame: The outcome measures were collected at four-time points: at enrollment, immediately after delivering the intervention package, one month and three months after the intervention.
The level of psychological distress was measured through the mean scores of the Sinhala version of the Distress Thermometer. The Distress Thermometer is 1 item, an ultra-short, visual analogue screening tool, originally developed in the America for prostate cancer patients in 1998. The Distress Thermometer comes with a Problem List. This has 35 items and it covers 5 life domains (practical, family/social, emotional, spiritual, and physical problems). The Distress Thermometer and Problem List were translated into the Sinhala language (the primary language in Sri Lanka) and cross-culturally adapted to Sri Lanka.
The outcome measures were collected at four-time points: at enrollment, immediately after delivering the intervention package, one month and three months after the intervention.
Patient's quality of life related to the Head and Neck condition
Time Frame: This outcome measure was collected at four-time points: at enrollment, immediately after delivering the intervention package, 1 month after and three months after the intervention.
This was measured using Head & Neck-35 module (H&N-35) by European Organization for Research and Treatment of Cancer. This tool was translated and validated to Sri Lanka through a large-scale multi-centre study. A high score in H&N-35 module also meant high level of problems whcih meant low quality of life.
This outcome measure was collected at four-time points: at enrollment, immediately after delivering the intervention package, 1 month after and three months after the intervention.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Patient's satisfaction
Time Frame: This was measured 3 months after the delivery of the intervention package
Patient's satisfaction with the novel intervention was measured using a validated questionnaire.
This was measured 3 months after the delivery of the intervention package

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Colombo

Investigators

  • Study Director: Irosha Perera, Doctor of Medicine, Preventive oral Health Unit, National Dental Hospital, Sri Lanka
  • Study Director: Pushpakumara Kandapola Arachchige, Doctor of Medicine, National Cancer Institute, Maharagama- Apeksha Hospital, Sri Lanka

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 15, 2018

Primary Completion (Actual)

September 22, 2020

Study Completion (Actual)

September 22, 2020

Study Registration Dates

First Submitted

November 8, 2024

First Submitted That Met QC Criteria

December 9, 2024

First Posted (Estimated)

December 10, 2024

Study Record Updates

Last Update Posted (Estimated)

December 10, 2024

Last Update Submitted That Met QC Criteria

December 9, 2024

Last Verified

November 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • EC-18 097

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

IPD will not be required at any level for any purpose. Also, keeping to the ethical conduct- I am obliged to protect the confidentiality of the participants. Therefore, as ICP serve no good purpose I will not share them

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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