乳腺癌对患者-照顾者二人组造成了重大的困扰。尽管心理社会和/或移动健康（mHealth）干预已经显示出改善二人组心理社会福祉的有效性，但还没有综合研究评估了针对乳腺癌患者-照顾者二人组提供的此类干预措施的效果。本研究旨在综合现有证据，评估mHealth心理社会干预对乳腺癌患者-照顾者二人组心理社会福祉的改善效果（主要结果为二人关系调整、抑郁和焦虑；次要结果为压力、症状困扰、社会福祉和关系质量），并与主动或非主动对照进行比较。我们进行了一项系统综述和荟萃分析。 从七个电子数据库（PubMed，CENTRAL，CINAHL，Embase，PsycINFO，Scopus，Web of Science），正在进行的试验登记（ClinicalTrials.gov，WHO ICTRP）和灰色文献（ProQuest Dissertations and Theses Global）中全面检索了随机对照试验和准实验研究，时限为数据库成立至2022年12月23日。纳入了参与mHealth心理社会干预的乳腺癌患者-照顾者二人组的研究，与主动或非主动对照进行比较。排除标准包括末期患者和/或具有精神障碍或认知障碍的参与者以及收集症状数据、促进乳腺癌筛查或仅涉及体育活动的干预措施。两位评审员独立进行了研究的筛选、数据提取和质量评估。使用Cochrane风险偏倚工具1版和JBI批判性评价检查表分别评估了随机对照试验和准实验研究的质量。采用Review Manager 5.4.1进行荟萃分析，综合了感兴趣结果的效果。进行了敏感性和亚组分析。使用GRADE方法评估了整体证据质量。 纳入了12项研究，涉及1204个乳腺癌患者-照顾者二人组。荟萃分析发现，干预后对照组中的479名照顾者（5项研究）的抑郁（标准化平均差值（SMD）= 0.43，95%置信区间（CI）[0.09, 0.77]，Z = 2.47，p = 0.01）和压力（SMD = 0.25，95% CI [0.05, 0.45]，Z = 2.44，p = 0.01）显著增加。对其他结果的干预效果统计上不显著。这类干预措施的有益效果仍然不确定。整体证据质量对于所有主要结果都非常低。 关于mHealth心理社会干预对乳腺癌患者-照顾者二人组心理社会福祉的有效性的结果尚不确定。荟萃分析显示了较高的异质性，整体证据质量非常低，因此需要谨慎解读研究结果。需要进行高质量的研究来评估心理社会干预措施对二人组结果的影响，并确定最佳干预方案。

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.To synthesise available evidence examining the effectiveness of mHealth-based psychosocial interventions among breast cancer patient-caregiver dyads in improving their psychosocial well-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.A systematic review and meta-analysis.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.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.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.