Abstract
BACKGROUND: Patients with gynecologic cancer receiving chemotherapy often report unmet supportive care needs. Compared with traditional face-to-face clinical interventions, mobile health can increase access to supportive care and may address patients' needs. Although app-based support programs have been developed to support patients with gynecologic cancer, their efficacy has not been adequately tested. OBJECTIVE: The aim of this study was to examine the efficacy of a mobile app for gynecologic cancer support (MGCS) for patients with gynecologic cancer receiving chemotherapy in China. METHODS: A multicenter randomized controlled trial was conducted in 2 university-affiliated hospitals in China. A total of 168 Chinese patients with gynecologic cancer were recruited and randomized to receive routine care or MGCS program plus routine care for 24 weeks. The Mishel uncertainty in illness theory guided the development of MGCS program, which has 4 modules: weekly topics, emotional care, discussion center, and health consultation. The primary outcome of this program was the assessment of the uncertainty in illness. The secondary outcomes were quality of life, symptom distress, and social support. All health outcomes were evaluated at baseline (T0), 12 weeks (T1), and 24 weeks (T2). Repeated measures analysis of covariance was used to assess the efficacy of the MGCS program. RESULTS: In this trial, 67 patients in the control group and 69 patients in the intervention group completed 2 follow-up assessments (response rate, 136/168, 81%). At 12 weeks, no significant differences were observed in any of the health outcomes between the 2 groups. At 24 weeks, compared to patients in the control group, those in the intervention group reported significant decreased uncertainty in illness (P<.001; d=-0.60; adjusted mean difference -7.69, 95% CI -11.31 to -4.07) and improved quality of life (P=.04; d=0.30; adjusted mean difference 4.77, 95% CI 0.12-9.41). CONCLUSIONS: The MGCS program demonstrated efficacy in supporting patients with gynecologic cancer receiving chemotherapy. This trial illustrates that an app-based program can be incorporated into routine care to support patients with cancer and suggests that allocation of more resources (grants, manpower, etc) to mobile health in clinics is warranted. TRIAL REGISTRATION: Chinese Clinical Trial Registry ChiCTR2000033678; https://www.chictr.org.cn/showproj.html?proj=54807.