Effectiveness of a digital health intervention on the supportive care needs and quality of life in Mexican patients with breast cancer: a randomized clinical trial

BACKGROUND: In Mexico, unmet supportive care needs are common among women with breast cancer treated in public hospitals, particularly needs regarding health systems and information. This study assessed the effectiveness of a digital patient-reported outcome (ePRO) intervention on these needs and quality of life. METHODS: We conducted a parallel arm, individually randomized clinical trial with 410 Mexican women undergoing chemotherapy at four hospitals of the Mexican Institute of Social Security. Participants were assigned to either an intervention group, which used the “OncoMama” ePRO application with proactive nursing follow-up, or a control group receiving standard care and links to breast cancer-related audiovisual resources. The primary outcomes were unmet needs related to health systems and information and overall quality of life at 6 months (primary effectiveness) and 9 months (sustainment). The intervention's effectiveness was evaluated by comparing the medians using quantile regression at 6 and 9 months and applying an intention-to-treat approach with inverse probability of censoring weighting for missing data. RESULTS: At 6 months, the intervention group showed statistically significant reductions compared to the control group in health systems and information needs (11.4 vs 20.5 points, p = 0.003) as well as improvement in overall quality of life (86.2 vs 80.9 points, p = 0.001). By 9 months, these effects remained significant for both information needs (4.5 vs 13.6 points, p = 0.003) and quality of life (87.4 vs 82.5 points, p = 0.002). CONCLUSIONS: ePRO intervention proved effective in reducing the need for supportive care and improving the overall quality of life of women with early-stage or locally advanced breast cancer undergoing chemotherapy. TRIAL REGISTRATION: This randomized controlled trial was registered at ClinicalTrials.gov on June 21, 2023, with the NCT identification number NCT05925257.