Early palliative care for patients with oral cancer in Sri Lanka: A non-randomized controlled trial.

Oral cancer is prevalent among Sri Lankan men and substantially compromises quality of life (QOL). Limited evidence exists on early palliative care in low- and middle-income countries. We assessed the effectiveness of an early palliative care intervention in improving psychological distress and QOL among patients with oral cancer in Sri Lanka. We conducted a non-randomized controlled trial with group allocation based on patients' residence. The study is registered as NCT06726317. We recruited from four tertiary care units providing oral cancer treatment in Sri Lanka: the oral and maxillofacial wards at the National Dental Hospital, Colombo (Teaching); Colombo South Teaching Hospital, Karapitiya; and the onco-surgery wards at the National Cancer Institute, Maharagama (Apeksha Hospital). The eligible participants were patients with oral cancer who had received their definitive diagnosis, reported psychological distress (score ≥4 on the Sinhala version of the Distress Thermometer), were awaiting surgery as the first treatment modality, and were married with at least one family caregiver able to communicate in Sinhalese. Exclusion criteria included recurrent oral cancer, a formal psychiatric diagnosis, or prior receipt of early palliative care. Participants were assigned to the intervention (n = 55) or control group (n = 55) based on the availability of an accessible Public Health Nursing Officer. The intervention group received an early palliative care package consisting of three structured sessions. The first session was delivered by the principal investigator (a trained dental surgeon and public health professional) during the hospital stay before surgery. The second and third sessions were provided by trained Public Health Nursing Officers at participants' homes, one and three weeks after discharge. Each session lasted about two hours and included information provision, management of acute and functional issues, nutritional care, psychological support, mindfulness therapy, and coordination of financial assistance. The control group received standard care within the health system, which included ad hoc symptom management on request without a structured palliative care component. The effectiveness was assessed using the Sinhala version of the Distress Thermometer for psychological distress and the EORTC QLQ-C30 with the H&N35 module for QOL at baseline (T0), post-intervention (T1), one month (T2), and three months (T3). All 110 eligible participants completed the intervention and follow-up (response rate 100%). At baseline, there were no significant differences between groups in distress (p = 0.7) or QOL. Over time, the intervention group showed greater reductions in distress (mean difference = -2.26; 95% CI: -3.35 to -1.07; p = 0.0001). After adjusting for baseline scores and potential confounders, the intervention group reported higher Global Health Status (17.1; 95% CI: 6.9-27.3; p = 0.001) and Functional Status (23.6; 95% CI: 5.7-41.5; p = 0.01), as well as lower Symptom Status (23.2; 95% CI: 5.6-40.8; p = 0.01) and H&N35 symptom burden (16.8; 95% CI: 6.8-26.8; p = 0.001) compared with controls. We conclude that the early palliative care intervention showed promising effectiveness in reducing psychological distress and improving quality of life among patients with oral cancer in Sri Lanka. Public Health Nursing Officers may play a key role in linking tertiary and community care to enhance patient well-being. Larger studies across diverse populations are needed to confirm these findings.