JMIR Publications

ABSTRACT

Background:

Breast cancer surgery and corresponding treatments have significant residual effects on breast cancer survivors (BCSs) in China. Body image distress and stigma are persistent challenges that negatively affects their quality of life. Accessible, sustainable, and cost-effective support remains scarce.

Objective:

This trial aimed to evaluate the effectiveness and cost-effectiveness of an app-based mindfulness breast care (MBC) program in addressing body image distress and stigma for BCSs.

Methods:

A randomized controlled trial was carried out in 2 university-affiliated hospitals in China. BCSs who had completed primary treatments and had mobile phone internet access were recruited and randomly assigned at 1:1 ratio to the intervention (MBC program plus routine care) or the control group (routine care alone). Under the conceptualization of Mindfulness-based cognitive therapy, the MBC program was developed including 3 modules: (1) Library, (2) Mindfulness Yoga, and (3) Mindfulness Practices. The MBC program lasted for 3 months. The primary outcomes measured were body image distress and stigma, and secondary outcomes included sleep quality, social support, and quality of life. Assessments were conducted at baseline, 3 months, and 6 months. An intention-to-treat approach, utilizing a multiple imputation method, was employed to handle missing data. A generalized linear regression model was fitted to evaluate the effectiveness. The incremental cost per quality-adjusted life year (QALY) gained was used to measure the cost-effectiveness.

Results:

A total of 192 BCSs participated in the baseline assessment, with 155 completing the two follow-up surveys. The median of the total usage duration (minute) was 199.60 (IQR 70.90-451.31, mean 360.59, SD 511.72), and the median of the total login frequency (time) was 39.50 (IQR 19.00-86.50, mean 59.26, SD 50.26). The reduction in body image distress at 6 months (adjusted mean difference, −1.80; 95% CI, −3.81 to −0.20, P=.022) and the reduction in stigma at 3 months (adjusted mean difference, −4.63; 95% CI, −7.66 to −1.61, P=.003) and 6 months (adjusted mean difference, −5.09; 95% CI, −8.26 to −1.92, P=.002) were statistically significantly greater in the intervention group compared to the control group. No statistically significant group differences were observed at 3 months or 6 months regarding sleep quality, social support, and quality of life. The cost-effectiveness analysis showed that the intervention group gained more quality-adjusted life years (QALYs) than the control group at 6 months (adjusted mean difference, 0.008; 95% CI, 0.002 to 0.014, P=.016). The incremental cost per QALY gained at 6 months was $23,732.50, indicating a 56.33% probability that MBC program is a cost-effective intervention at a threshold of $37,530, three times of China's 2023 GDP per capita.

Conclusions:

An app-based mindfulness breast care program was effective and cost-effective, and had the potential to be scalable for clinical practice. Clinical Trial: Chinese Clinical Trial Registry ChiCTR2200059952; https://www.chictr.org.cn/showproj.html?proj=167247.