Effect of a Multidimensional Digital Health Intervention on Quality of Life in Breast Cancer Survivors: A Randomized Controlled Trial.

Abstract / Summary

We evaluated whether offering access to a multicomponent mHealth app improves quality of life (QoL) and psychosocial outcomes among breast cancer survivors under pragmatic, nonprescriptive conditions. In this single-center, randomized, controlled trial at Hospital Clínic de Barcelona, women age ≥18 years, disease-free after breast cancer treatment, were recruited (December 2020-December 2021) and randomly assigned 1:1 to usual follow-up plus app access or usual follow-up alone. The app provided CTCAE v4.03-aligned symptom tracking with self-care guidance, educational content, an events calendar, and gamified smartphone-based step counting; no protocolized clinician monitoring or feedback was provided. Outcomes were assessed at baseline and 3, 6, 9, and 12 months using European Organisation for Research and Treatment of Cancer-Quality of Life Questionnaire (QLQ)-C30/BR23, Hospital Anxiety and Depression Scale (HADS), and Three-Item Loneliness Scale (TILS). The primary end point was the difference in QLQ-C30 Global Health Status/QoL at 3 months. Analyses followed intention-to-treat using mixed models for repeated measures adjusted for baseline values. Of 124 women assessed, 121 were randomized (intervention n = 60; control n = 61). Patient-reported outcome measures were available for 106 of 121 (87.6%) at 3 months and 95 of 121 (78.5%) at 12 months. At 3 months, there was no significant difference in Global Health Status/QoL (adjusted mean difference [Intervention-Control], -2.24 [95% CI, -9.29 to 4.81]; P = .53); estimates at later time points were similarly imprecise. No significant between-group difference were observed for QLQ-BR23 domains, HADS anxiety/depression, or TILS. Exploratory subgroup analyses suggested possible heterogeneity in TILS by hormonal-treatment category; this was descriptive and hypothesis-generating only. App engagement was the highest in months 0-3 (48/60 [80.0%] with any use) and declined thereafter; 12 of 60 (20.0%) never used the app. In a pragmatic, nonprescriptive survivorship trial, offering access to a multicomponent mHealth app without closed-loop clinical integration did not show a statistically significant between-group differences in QoL or psychosocial outcomes; confidence intervals were compatible with meaningful harm and did not exclude small benefit depending on the threshold used to define clinical relevance.

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