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NCT Number: NCT06726317

Early Palliative Care For Patients With Oral Cancer in Sri Lanka

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.

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Key information

Conditions

Oral Cancer Head and Neck Neoplasms Mouth Diseases Mouth Neoplasms Neoplasms Neoplasms by Site Palliative Supportive Care Psychological Distress Quality of Life of Patients Stomatognathic Diseases

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Karapitiya Teaching Hospital, Galle, Southern Province, Sri Lanka

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About this study

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).

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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

Other names: Supportive care, Psycho-oncology care

Primary outcomes

  1. 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

  2. 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.

  3. 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.

Secondary outcomes

  1. 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.

Sponsors and collaborators

Lead sponsor

University of Colombo

Other

Registry information

Official study title

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

Important dates

Study start
2018
Primary completion
2020
Study completion
2020
First posted
Dec 10, 2024
Registry last updated
Dec 10, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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