Clinical trial · Interventional
Early Palliative Care For Patients With Oral Cancer in Sri Lanka
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
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (4)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Oral Cancer | Malignant Lip and Oral Cavity Neoplasm | CURATED_BROADER | 0.80 |
| Palliative Supportive Care | — | UNRESOLVED | — |
| Psychological Distress | — | UNRESOLVED | — |
| Quality of Life of Patients | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Early palliative care integration | Behavioral | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Intervention group receiving the novel early palliative care package
- description
- This group received the novel early palliative care intervention package
- interventionNames
- Behavioral: Early palliative care integration
- type
- NO_INTERVENTION
- label
- Control group
- description
- This group received only the existing standard care in the health system and did not receive any special intervention through this study
Primary outcomes (3)
- measure
- Patient's quality of life
- timeFrame
- 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.
Eligibility
Eligibility (as posted)
- Sex
- All
Show eligibility criteria text
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.
References
Publications (68)
- BACKGROUNDCreamer M, Bell R, Failla S. Psychometric properties of the Impact of Event Scale - Revised. Behav Res Ther. 2003 Dec;41(12):1489-96. doi: 10.1016/j.brat.2003.07.010. PMID 14705607
- RESULTKadan-Lottick NS, Vanderwerker LC, Block SD, Zhang B, Prigerson HG. Psychiatric disorders and mental health service use in patients with advanced cancer: a report from the coping with cancer study. Cancer. 2005 Dec 15;104(12):2872-81. doi: 10.1002/cncr.21532. PMID 16284994
- RESULTKabat-Zinn J, Massion AO, Kristeller J, Peterson LG, Fletcher KE, Pbert L, Lenderking WR, Santorelli SF. Effectiveness of a meditation-based stress reduction program in the treatment of anxiety disorders. Am J Psychiatry. 1992 Jul;149(7):936-43. doi: 10.1176/ajp.149.7.936. PMID 1609875
- RESULTJayasekara H, Rajapaksa LC, Aaronson NK. Health-related quality-of-life in patients with head-and-neck cancer in Sri Lanka: psychometric properties of the 'Sinhala' version of the EORTC QLQ-H&N35. Psychooncology. 2009 Oct;18(10):1116-21. doi: 10.1002/pon.1430. PMID 19142857
- RESULTJayakar R, Choi J, MacKinnon C, Tan S. The cost of major head and neck cancer surgery. N Z Med J. 2017 May 12;130(1455):111-119. PMID 28494483
- RESULTJacobsen PB, Jim HS. Psychosocial interventions for anxiety and depression in adult cancer patients: achievements and challenges. CA Cancer J Clin. 2008 Jul-Aug;58(4):214-30. doi: 10.3322/CA.2008.0003. Epub 2008 Jun 16. PMID 18558664
- RESULTIp WY, Martin CR. Psychometric properties of the 12-item General Health Questionnaire (GHQ-12) in Chinese women during pregnancy and in the postnatal period. Psychol Health Med. 2006 Feb;11(1):60-9. doi: 10.1080/13548500500155750. PMID 17129895