Brief psychological intervention to reduce psychological distress among pre-operative cancer patients: A randomized, single-blind, two arm, parallel group-controlled trial in a selected tertiary care hospital in Sri Lanka

Purpose: Psychological distress among pre-operative cancer patients interferes with treatment outcomes. The objective of this study is to determine the effectiveness of a 3-week brief psychological intervention versus routine care on reducing psychological distress among newly diagnosed cancer patients awaiting surgery.Methods: A randomized, single-blind, two arm, parallel groupcontrolled trial was conducted among 88 (intervention=46, control=42) newly diagnosed cancer patients awaiting surgery at Colombo South Teaching Hospital. The primary outcome, psychological distress, was assessed using HADS (cut-off 8) at baseline and 3-weeks later. Secondary outcomes assessed were satisfaction on knowledge and care they received and the physical well-being. Comparisons were made using McNemar’s Chi-Square at p<0.05 based on intention to treat. Effects measures used are odds ratios (OR) with 95% CI and number needed to treat (NNT).Results: The prevalence of anxiety and depression at baseline was 90.91% and 89.77%. Intervention significantly lowered anxiety [intervention 30.43% vs control 69.50%, OR=0.20 (95% CI 0.08, 0.49), p=0.0004]. Depression failed to show a significant reduction [67.6% vs 78.4%, OR=0.53 (95% CI 0.22, 1.28), p=0.1592]. NNT to avert one case of anxiety is 3 (95% CI 1.73, 5.18). Satisfaction on care received is the only secondary outcome that showed a statistically significant association: intervention 36.96% vs. control 14.28% [OR=0.28 (95% CI 0.10-0.81), p=0.0057].Conclusions: The brief psychological intervention was effective in reducing anxiety among newly diagnosed cancer patients. This simple and brief psychological intervention could be recommended for all new cancer patients awaiting surgical interventions. This trial was registered in the Sri Lanka clinical trial registry on 14.10.2021. The registration number is SLCTR/2021/028. The protocol is available at the Sri Lanka Clinical Trial Registry website. The Universal Trial Number (UTN) is U1111-1269-2819.