Early Palliative Care for Patients with Oral Cancer in Sri Lanka

NCT06726317 | Completed

• 1 other identifier: EC-18 097
• Study Type: interventional
• Target: 110
• Locations: 1 country
• Sites: 4

Brief 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.

Conditions

Oral Cancer; Palliative Supportive Care; Psychological Distress; Quality of Life of Patients

Keywords

early palliative care interventions; oral cancer; head and neck cancer; quality-of-life; psychological distress; supportive care; mindfulness therapy

Outcome Measures

Primary Outcomes (3)

• Patient's quality of life

  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

  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

  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 Outcomes (1)

• Patient's satisfaction

  This was measured 3 months after the delivery of the intervention package

Study Arms (2)

Intervention group receiving the novel early palliative care package

EXPERIMENTAL

This group received the novel early palliative care intervention package

Behavioral: Early palliative care integration

Control group

NO INTERVENTION

This group received only the existing standard care in the health system and did not receive any special intervention through this study

Interventions

Early palliative care integration BEHAVIORAL

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

Also known as: Supportive care, Psycho-oncology care

Intervention group receiving the novel early palliative care package

Eligibility Criteria

• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• University of Colombo: lead

Study Sites (4)

Karapitiya Teaching Hospital

Galle, Southern Province, Sri Lanka

Location

National Dental Hospital

Colombo, Western Province, 0007, Sri Lanka

Location

Apeksha Hospital

Colombo, Western Province, Sri Lanka

Location

Colombo South (Teaching) Hospital

Colombo, Western Province, Sri Lanka

Location

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Related Links

• Related Info

MeSH Terms

Conditions

Mouth Neoplasms; Head and Neck Neoplasms

Interventions

Palliative Care

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Mouth Diseases; Stomatognathic Diseases

Intervention Hierarchy (Ancestors)

Patient Care; Therapeutics; Health Services; Health Care Facilities Workforce and Services

Study Officials

• 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

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal investigator

Model Details: This was a Quasi Experimental study with a parallel control group

Study Record Dates

• First Submitted: November 8, 2024
• First Posted: December 10, 2024
• Study Start: December 15, 2018
• Primary Completion: September 22, 2020
• Study Completion: September 22, 2020
• Last Updated: December 10, 2024

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will not share

Locations

SR (4)