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Mobile health and supervised rehabilitation versus mobile health alone in breast cancer survivors: randomized controlled trial [with consumer summary]
Lozano-Lozano M, Martin-Martin L, Galiano-Castillo N, Fernandez-Lao C, Cantarero-Villanueva I, Lopez-Barajas IB, Arroyo-Morales M
Annals of Physical and Rehabilitation Medicine 2020 Jul;63(4):316-324
clinical trial
8/10 [Eligibility criteria: Yes; Random allocation: Yes; Concealed allocation: Yes; Baseline comparability: Yes; Blind subjects: No; Blind therapists: No; Blind assessors: Yes; Adequate follow-up: Yes; Intention-to-treat analysis: Yes; Between-group comparisons: Yes; Point estimates and variability: Yes. Note: Eligibility criteria item does not contribute to total score] *This score has been confirmed*

BACKGROUND: 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. OBJECTIVE: 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. METHODS: This randomized controlled trial included 80 survivors of breast cancer diagnosed at stage I to 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 2 months (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. RESULTS: 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 to 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% versus 26.3%, p = 0.008). Improvement in subjective and objective upper-limb functionality was also higher with BENECA mHealth and rehabilitation. CONCLUSIONS: 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.

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