EHealth intervention for quality of life in long-term breast cancer survivors: Randomized controlled trial.

Résumé

BACKGROUND: Digital health interventions have shown promise for improving quality of life, especially in the short term after treatment. However, evidence regarding long-term breast cancer survivors (LT-BCSs; disease free >5 years) remains limited. This study aimed to evaluate the effectiveness of an eHealth intervention targeting health promotion and late sequelae management to improve LT-BCSs' quality of life.METHODS: In a randomized controlled clinical trial, 201 LT-BCSs (mean 11 years posttreatment) were randomly assigned to an interventio group (n = 102) using the CUMACA-M mobile application with specific health advice and recommendations for LT-BCSs, or a control group (n = 99) receiving usual care. Quality of life was measured with the Quality of Life-Cancer Survivors scale (QOL-CS) at baseline and after 3 months. Analyses followed an intention-to-treat approach using t-tests, nonparametric tests, and effect sizes.RESULTS: At three months, no statistically or clinically significant differences between the groups in the overall quality of life score (QOL-CS) were found (difference of differences = 0.11; 95% CI -0.10 to 0.32; p = .303). In the intervention group, a small intragroup decrease in spiritual well-being was observed -0.25 (-0.49 to -0.02), of uncertain clinical significance; no significant differences between groups were detected.CONCLUSIONS: This eHealth intervention did not improve the quality of life of LT-BCSs, suggesting that more personalized, interactive, or professionally supported strategies may be needed. Future research should evaluate the long-term outcomes and effectiveness of hybrid or personalized digital strategies in this population.TRIAL REGISTRATION: ClinicalTrials.gov NCT05322460; https://clinicaltrials.gov/study/NCT05322460.