Accepted for/Published in: JMIR mHealth and uHealth
Date Submitted: Oct 24, 2025
Date Accepted: Jun 15, 2026
Feasibility, Usability, and Preliminary Effectiveness of a Mobile Health Application to Promote Screening Behaviors Among High-Risk Populations for Breast Cancer: A Randomized Controlled Pilot Study
ABSTRACT
Background:
Breast cancer represents a major public health challenge for women globally. Women with breast cancer risk factors are more likely to develop the disease than the general populations. Breast cancer screening is an effective measure for preventing breast cancer, especially for high-risk populations. While current screening participation rates among high-risk populations of breast cancer remain poor.
Objective:
The research team developed a mobile health application named “Ruaikang” to enhance breast health awareness and improve adherence to early screening among high-risk populations. This study aimed to evaluate the feasibility, usability, and preliminary effectiveness of the application.
Methods:
This pilot randomized controlled trial assigned eligible participants in a 1:1 ratio to either a four-week intervention using the “Ruaikang” mobile health application or a control group that received the “Breast Cancer Screening Guidelines” manual. Feasibility was assessed using recruitment and completion rates, and usability was evaluated using the System Usability Scale. Preliminary effectiveness was assessed through measurements of willingness to participate in breast cancer screening, screening knowledge, health beliefs, and self-efficacy. Semi-structured interviews were conducted to collect participants’ experience and suggestions for the application.
Results:
Of the 62 eligible women approached, 50 were enrolled (recruitment rate 80.6%) and randomized into two groups (25 per group). In the intervention group, 19 participants completed the study (completion rate 76%). The average score of system usability scale was 88.82 ± 10.29. At the forth week, the intervention group demonstrated significant differences compared to the control group in willingness to participate in breast cancer screening, screening knowledge, health beliefs, and self-efficacy. By the eighth week, significant differences persisted in screening knowledge, health beliefs, and self-efficacy. Interviews with 8 participants identified two core themes: “advantages and positive user experiences”, and “shortcomings and improvement recommendations”.
Conclusions:
The “Ruaikang” mobile health application demonstrated good feasibility and usability, showing promise in promoting breast cancer screening among high-risk populations. Future research should focus on further optimizing the application and conducting larger-scale trials with extended follow-up to confirm its long-term effectiveness. Clinical Trial: Chinese Clinical Trial Registry ChiCTR2500108593; https://www.chictr.org.cn/bin/project/edit?pid=284428
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