Mobile App for Gynecologic Cancer Support for Patients With Gynecologic Cancer Receiving Chemotherapy in China: Multicenter Randomized Controlled Trial.
Mobile App for Gynecologic Cancer Support for Patients With Gynecologic Cancer Receiving Chemotherapy in China: Multicenter Randomized Controlled Trial.
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DOI：
10.2196/49939
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发表时间：
2023-11-13
影响因子：
7.4
通讯作者：
中科院分区：
文献类型：
--
作者：
接受化疗的妇科癌症患者经常报告未满足的支持性护理需求。与传统的面对面临床干预措施相比，移动医疗可以增加获得支持性护理的机会，并可能满足患者的需求。尽管基于应用程序的支持程序已经开发出来支持妇科癌症患者，但它们的功效还没有得到充分的测试。本研究的目的是检验妇科癌症支持（MGCS）移动应用程序对中国接受化疗的妇科癌症患者的疗效。在中国两所大学附属医院进行了一项多中心随机对照试验。共招募168名中国妇科癌症患者，随机接受常规治疗或MGCS计划加常规治疗，为期24周。在米歇尔疾病不确定性理论的指导下，MGCS项目的发展分为四个模块：每周主题、情感关怀、讨论中心和健康咨询。该项目的主要结果是对疾病不确定性的评估。次要结局是生活质量、症状困扰和社会支持。在基线（T0）、12周（T1）和24周（T2）评估所有健康结果。使用协方差的重复测量分析来评估MGCS方案的有效性。在本试验中，对照组67例患者和干预组69例患者完成了2次随访评估（有效率为136/168,81%）。12周时，两组之间的任何健康结果均无显著差异。在24周时，与对照组患者相比，干预组患者的疾病不确定性显著降低（P< 0.001; d= -0.60；调整平均差值-7.69,95% CI -11.31至-4.07），生活质量显著改善（P= 0.04; d=0.30；调整平均差值4.77,95% CI 0.12-9.41）。MGCS项目在支持接受化疗的妇科癌症患者方面证明了其有效性。该试验表明，基于应用程序的项目可以纳入常规护理，以支持癌症患者，并建议为诊所的移动医疗分配更多资源（赠款、人力等）是必要的。中国临床试验注册中心ChiCTR2000033678；https://www.chictr.org.cn/showproj.html?proj=54807
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. 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. 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. 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). 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. Chinese Clinical Trial Registry ChiCTR2000033678; https://www.chictr.org.cn/showproj.html?proj=54807
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