Effectiveness and Cost-Effectiveness of an App-Based Mindfulness Breast Care Program for Reducing Body Image Distress and Stigma Among Survivors of Breast Cancer: Randomized Controlled Trial.

Abstract

Breast cancer surgery and corresponding treatments have significant residual effects on survivors of breast cancer in China. Body image distress and stigma are persistent challenges that negatively affect their quality of life. Accessible, sustainable, and cost-effective support remains scarce. This study 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 survivors of breast cancer. We carried out a randomized controlled trial in 2 university-affiliated hospitals in China. Survivors of breast cancer who had completed primary treatments and had mobile phone internet access were recruited and randomly assigned at a 1:1 ratio to the intervention (3-month 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 three modules: (1) Library, (2) Mindfulness Yoga, and (3) Mindfulness Practices. The primary outcomes measured were body image distress and stigma, and secondary outcomes included sleep quality, social support, and quality of life (physical and mental well-being). Assessments were conducted at baseline, 3 months (T1), and 6 months (T2). Multiple imputation was used to handle missing data and generalized estimating equations were fitted to evaluate the effectiveness. The incremental cost per quality-adjusted life year (QALY) gained was used to measure cost-effectiveness. A total of 192 survivors of breast cancer participated in the baseline assessment, with 155 completing the 2 follow-up surveys. The median total usage duration was 199.60 (IQR 70.90-451.31; mean 360.59, SD 511.72) minutes, and total login frequency was 39.50 (IQR 19.00-86.50; mean 57.02, SD 50.26) times. The reduction in body image distress at T2 (adjusted mean difference -1.91; 95% CI -3.40 to -0.42; P=.01; d=-0.31), the reduction in stigma at T1 (adjusted mean difference -5.83; 95% CI -8.46 to -3.20; P<.001; d=-0.61) and T2 (adjusted mean difference -7.79; 95% CI -10.62 to -4.97; P<.001; d=-0.82), and the improvement in mental well-being at T1 (adjusted mean difference 4.44; 95% CI 1.70 to 7.18; P=.002; d=0.43) were statistically significantly greater in the intervention group compared with the control group. No statistically significant group differences were observed regarding sleep quality, social support, and physical well-being. The cost-effectiveness analysis showed that the intervention group gained more QALYs than the control group at T2 (adjusted mean difference 0.008; 95% CI 0.004 to 0.016; P=.01). The incremental cost per QALY gained at T2 was US $19,431.25, indicating a 57% probability that the MBC program is a cost-effective intervention at a threshold of US $37,530, three times the 2023 gross domestic product per capita of China. An app-based MBC program was effective and potentially cost-effective and had the promise to be scalable for clinical practice. Chinese Clinical Trial Registry ChiCTR2200059952; https://www.chictr.org.cn/showproj.html?proj=167247.