Effectiveness of an Innovative Mobile-Based Perioperative Care Program for Women Undergoing Breast Cancer Surgery (iCareBreast): Randomized Controlled Trial.

backgroundBreast cancer is one of the most prevalent cancers among women and significantly impacts psychological well-being and health-related quality of life (HR-QoL) during the perioperative period. Mobile health interventions offer a promising approach to providing education and psychosocial support, yet their effectiveness in this context remains underexplored.

objectiveThis study aimed to develop and evaluate the effectiveness of an innovative, mobile-based, perioperative care program for women undergoing breast cancer surgery (iCareBreast). The assessment focused on perioperative self-efficacy, anxiety, depression, fatigue, HR-QoL, and perioperative care satisfaction.

methodsA two-group randomized control trial was conducted at a tertiary hospital in Singapore. The intervention group used the iCareBreast app, offering four main resources: perioperative care guidance, breast cancer and surgery education, psychological support, and social support. The control group received standard hospital care. Participants in the intervention group engaged with the fully automated app daily for 29 days (two weeks before surgery, on the day of surgery, and two weeks after surgery). Data were collected face-to-face or on the web at three time points: baseline, immediately after the intervention (T1; two weeks after surgery), and at a 2.5-month follow-up (T2; three months after surgery). The primary outcome was perioperative care self-efficacy, while secondary outcomes included anxiety, depression, fatigue, HR-QoL, and perioperative care satisfaction.

resultsA total of 123 patients with early-stage breast cancer scheduled for breast surgery were enrolled in the study, with 62 patients assigned to the iCareBreast group and 61 patients to the control group. The results showed no significant differences between the groups in the primary outcome-perioperative self-efficacy-at any time point. Baseline scores were similar (P=.80), and while the iCareBreast group showed slightly lower scores at T1 (mean difference [MD] -1.63, 95% CI -3.43 to 0.18; P=.08) and T2 (MD -1.90, 95% CI -4.06 to 0.26; P=.09), the differences were not statistically significant. Similarly, secondary outcomes, including anxiety, depression, fatigue, HR-QoL, and perioperative care satisfaction, showed no significant changes between groups (all P>.05). However, the iCareBreast group reported higher perioperative care satisfaction during the postintervention assessment. Satisfaction scores were comparable at T1 (P=.68), while at T2, the iCareBreast group showed a slight increase compared to the control group (MD 0.35, 95% CI 0.04-0.73; P=.08), though the difference was not statistically significant.

conclusionsThe mobile-based psychosocial intervention, although satisfied by users, did not demonstrate significant benefits compared to standard care. This highlights the need to refine the iCareBreast app in future iterations to enhance its effectiveness in addressing the targeted health outcomes. Future mobile health research should prioritize optimizing user engagement strategies and incorporating personalized approaches to better address the perioperative care needs of patients with breast cancer.

trial registrationClinicalTrials.gov NCT04172350; https://clinicaltrials.gov/study/NCT04172350.