Effect of Early Integration of Supportive Care in Addition to Standard Care in Patients with Breast Cancer: A Randomised Controlled Trial

Abstract Purpose Breast cancer is the most common malignancy among women in India, with a significant proportion diagnosed at advanced stages. These patients often endure a high symptom burden and compromised quality of life (QoL). Early integration of supportive care may improve outcomes, yet remains underutilised in resource-limited settings. This study evaluated the effect of early integration of supportive care alongside standard oncology treatment on QoL and symptom burden in breast cancer patients. Methods In this single-centre, randomised controlled trial, 110 newly diagnosed adult female breast cancer patients were randomised (1:1) into an intervention group (early supportive care and standard care) or control group (standard care only). Supportive care included symptom management, psychosocial counselling, and educational support. Outcomes were assessed at baseline and 3 months using European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30) and Edmonton Symptom Assessment Scale (ESAS). Statistical analyses included t-tests, multivariate regression, and mediation modelling. Results Both groups showed significant improvement in QoL, but greater symptom reduction was observed in the intervention group (mean ± SD ESAS reduction: 30.69 ± 15.51 vs. 22.9 ± 15.99; p = 0.014). Fatigue and pain were significantly lower in the supportive care group (Cohen's d = 0.55 and 0.38, respectively). The financial burden was also significantly reduced (p = 0.001), accompanied by higher patient and caregiver satisfaction scores (p = 0.032). Mediation analysis confirmed pain reduction as a key predictor of QoL improvement (p < 0.001). Conclusions Early integration of supportive care significantly reduces symptom burden, enhances psychological well-being, and lowers financial stress in breast cancer patients, supporting its inclusion as a standard adjunct to cancer care in developing countries. Trial Registration CTRI/2021/06/034136, Date 10/06/2021