Mobile health and supervised rehabilitation versus mobile health alone in breast cancer survivors: Randomized controlled trial.

Abstract

Survival rates in cancer are increasing exponentially, with a corresponding increase/influence in disability-adjusted life-years. Efforts should be made to explore the optimal balance between unsupervised/distance-based and supervised/onsite approaches to cancer care. This study aimed to compare the clinical efficacy of the BENECA mobile Health (mHealth) lifestyle application combined with a supervised rehabilitation program (BENECA and supervised rehabilitation) versus the BENECA mHealth lifestyle application alone on quality of life (QoL) and functional outcomes of breast cancer survivors. This randomized controlled trial included 80 survivors of breast cancer diagnosed at stage I-IIIA, who completed adjuvant therapy and were overweight or obese at diagnosis. Participants were randomly allocated (ratio 1:1, 3 waves) to BENECA mHealth and rehabilitation for 2months (n=40) or BENECA mHealth and usual care (BENECA mHealth alone; n=40). Participants completed a questionnaire at baseline (T1), 8-weeks post-intervention (T2) and 6-month follow-up (T3). The primary outcome was QoL assessed with the EORT QLQ-C30. Secondary outcomes included upper-limb functionality and body composition. Statistical (between-group analyses of covariance) and clinical effects were analyzed by intention to treat. Both groups showed improved outcomes, but global QoL was significantly better with BENECA mHealth and rehabilitation than BENECA mHealth alone (mean difference, 12.76; 95% confidence interval 4.85; 20.67; P=0.004), with a moderate-to-large effect size (d=72). The proportion of participants reporting reliable clinical improvement on global QoL at T2 was higher with BENECA mHealth and rehabilitation than BENECA mHealth alone (57.5% vs 26.3%, P=0.008). Improvement in subjective and objective upper-limb functionality was also higher with BENECA mHealth and rehabilitation. The BENECA mHealth lifestyle application with a supervised rehabilitation program had a statistically and clinically significant effect on QoL and upper-limb functionality in breast cancer survivors and is a unique and important promising new approach.