Accepted for/Published in: Journal of Medical Internet Research
Date Submitted: Jan 24, 2025
Open Peer Review Period: Jan 23, 2025 - Mar 20, 2025
Date Accepted: Mar 7, 2025
(closed for review but you can still tweet)
Effectiveness of an innovative mobile-based perioperative Care program for women undergoing Breast cancer surgery (iCareBreast): randomized controlled trial
ABSTRACT
Background:
Breast cancer is one of the most prevalent cancers among women and significantly impacts psychological well-being and health related quality of life 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.
Objective:
This 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, cancer-related fatigue, health-related quality of life, and perioperative care satisfaction.
Methods:
A two-group randomized control trial was conducted at a tertiary hospital in Singapore. The intervention group used 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 app daily fully automated for 29 days (two weeks before surgery, day of surgery and two weeks after surgery). Data were collected face to face or web-based at three time points: baseline, immediately post-intervention (two weeks after surgery), and at a two and half-month follow-up (three months post-surgery). The primary outcome was perioperative care self-efficacy, while secondary outcomes included anxiety, depression, fatigue, health-related quality of life, and perioperative care satisfaction.
Results:
A total of 123 early-stage breast cancer patients scheduled for breast surgery were enrolled in the study, with 62 assigned to the intervention group and 61 to the control group. The results showed no significant differences between the intervention and control groups in the primary outcome, perioperative care self-efficacy. Similarly, secondary outcomes including anxiety, depression, fatigue, quality of life, or perioperative care satisfaction demonstrated no significant changes between the groups. However, the intervention group reported higher perioperative care satisfaction score during the post- intervention assessment.
Conclusions:
The mobile-based psychosocial intervention, although satisfied by users, did not demonstrate significant benefits compared over standard care. This highlights the need for refining the iCareBreast application in future iterations to enhance its effectiveness in addressing the targeted health outcomes. Future mHealth research should prioritize optimizing user engagement strategies and incorporating personalized approaches to better address the perioperative care needs of breast cancer patients. Clinical Trial: ClinicalTrials.gov NCT04172350; https://clinicaltrials.gov/study/NCT04172350
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