Effectiveness of mHealth-based psychosocial interventions for breast cancer patients and their caregivers: A systematic review and meta-analysis

Background: Breast cancer causes significant distress in patient-caregiver dyads. While psychosocial and/or mHealth-based interventions have shown efficacy in improving their psychosocial well-being, no reviews have synthesised the effectiveness of such interventions delivered specifically to the breast cancer patient-caregiver dyad. Objective: To synthesise available evidence examining the effectiveness of mHealth-based psychosocial interventions among breast cancer patient-caregiver dyads in improving their psychosocialwell-being (primary outcomes: dyadic adjustment, depression and anxiety; secondary outcomes: stress, symptom distress, social well-being and relationship quality), compared to active or non-active controls. Design: A systematic review and meta-analysis. Methods: Randomised controlled trials and quasi-experimental studies were comprehensively searched from seven electronic databases (PubMed, CENTRAL, CINAHL, Embase, PsycINFO, Scopus, Web of Science), ongoing trial registries (ClinicalTrials.gov, WHO ICTRP) and grey literature (ProQuest Dissertations and Theses Global) from inception of databases till 23 December 2022. Studies involving breast cancer patient-caregiver dyads participating in mHealth-based psychosocial interventions, compared to active or non-active controls, were included. Exclusion criteria were terminally ill patients and/or participants with psychiatric disorders or cognitive impairment and interventions collecting symptomatic data, promoting breast cancer screening or involving only physical activities. Screening, data extraction and quality appraisal of studies were conducted independently by two reviewers. Cochrane Risk of Bias Tool version 1 and JBI Critical Appraisal Checklist were used to appraise the randomised controlled trials and quasi-experimental studies, respectively. Meta-analyses using Review Manager 5.4.1 synthesised the effects of outcomes of interest. Sensitivity and subgroup analyses were conducted. The GRADE approach appraised the overall evidence quality. Results: Twelve trials involving 1204 breast cancer patient-caregiver dyads were included. Meta-analyses found statistically significant increase in caregiver anxiety (standardised mean difference (SMD)= 0.43,95% confidence interval (CI) [0.09, 0.77], Z=2.47, p=0.01), involving 479 caregivers in 5 studies, and stress (SMD=0.25, 95% CI [0.05, 0.45], Z=2.44, p=0.01), involving 387 caregivers in 4 studies post-intervention, favouring control groups. The intervention effects on the remaining outcomes were statistically insignificant. Beneficial effects of such interventions remain uncertain. The overall quality of evidence was very low for all primary outcomes. Conclusions: Results of the effectiveness of mHealth-based psychosocial interventions on the psychosocial well-being of breast cancer patient-caregiver dyads are inconclusive. The high heterogeneity shown in the meta-analyses and very-low overall quality of evidence imply the need for cautious interpretation of findings. Higher-quality studies are needed to assess the effects of psychosocial interventions on dyadic outcomes and determine optimal intervention regimes.