Effect of early integration of supportive care in addition to standard care in patients with breast cancer: A randomised controlled trial.

PURPOSE: Breast cancer is the most common malignancy among women in India, with patients often experiencing high symptom burden and compromised quality of life (QoL). Despite evidence supporting early supportive care integration, significant implementation gaps persist in low- and middle-income countries (LMICs). This study addresses the lack of feasible intervention models for resource-constrained settings and inadequate characterization of mechanisms through which early supportive care improves outcomes-particularly symptom-specific contributions and financial burden reduction.

METHODS

This single-centre, randomised controlled trial at All India Institute of Medical Sciences, New Delhi, randomised 110 newly diagnosed adult female breast cancer patients (1:1) into intervention (early supportive care plus standard care) or control (standard care only) groups. Supportive care included symptom management, psychosocial counselling, and educational support. Outcomes were assessed at baseline and 3 months using EORTC QLQ-C30 and Edmonton Symptom Assessment Scale (ESAS). Statistical analyses included t-tests, multivariate regression, and mediation modelling.

RESULTS

Both groups showed significant QoL improvement, but greater symptom reduction occurred 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 [95% CI:0.17,0.94] and 0.38 [95% CI:0.00,0.75], respectively). Financial burden significantly reduced (p = 0.001), with higher patient and caregiver satisfaction (p = 0.032). Mediation analysis confirmed pain reduction as a key QoL predictor (p < 0.001).

CONCLUSIONS

Early supportive care integration significantly reduces symptom burden, enhances psychological well-being, and lowers financial stress, supporting its inclusion as standard adjunct cancer care in developing countries, providing actionable evidence for policymakers in LMICs.