Health Science Center, Shenzhen University, A1-403, 1066 Xueyuan Road, Nanshan District, Shenzhen, 518060, China.
Longgang Central Hospital of Shenzhen, Shenzhen, China.
BMC Health Serv Res. 2022 Aug 17;22(1):1052. doi: 10.1186/s12913-022-08443-y.
Gynecological malignant patients often have significant psychological and physical problems. The feasibility and generalizability of traditional intervention method is low due to the high time and labor cost, large number of gynecological malignant tumor patients in China, as well as shortage of health professionals. Therefore, it is necessary to design an alternative, innovative, and easily accessible intervention method. This study aims to evaluate the effect of WeChat-based intervention on anxiety, depression and disease-related symptoms of patients with gynecological malignant tumors during rehabilitation.
A single-blinded, randomized, controlled, parallel-group pre-test and repeated post-test design will be conducted. A total of 76 participants will be randomly divided into the intervention group and control group. Anxiety and depression, disease-related symptoms, coping ability, benefit finding and quality of life will be measured at baseline and repeated immediately after the intervention (test 1), 3 months (test 2) and 6 months (test 3) after the intervention.
As the first randomized controlled trial with rigorous research design for patients with gynecological malignant tumors in the rehabilitation stage in China, this study will provide evidences for the effectiveness of the WeChat platform during intervention of patients with gynecological malignant tumors in the rehabilitation stage. The results are helpful to further explore the effect of WeChat-based intervention on improving patients' anxiety and depression, disease-related symptoms, and quality of life.
Chinese Clinical Trial Registry: ChiCTR2100053450, Registered 21 November 2021, http://www.chictr.org.cn/searchproj.aspx.
妇科恶性肿瘤患者常存在明显的身心问题。由于时间和人力成本高、中国妇科恶性肿瘤患者数量多以及卫生专业人员短缺，传统干预方法的可行性和普遍性较低。因此，有必要设计一种替代的、创新的、易于获取的干预方法。本研究旨在评估基于微信的干预对妇科恶性肿瘤康复期患者焦虑、抑郁和疾病相关症状的影响。
采用单盲、随机、对照、平行组、预试验和重复后试验设计。共纳入 76 名参与者，随机分为干预组和对照组。在基线时和干预后立即（测试 1）、3 个月（测试 2）和 6 个月（测试 3）时分别测量焦虑和抑郁、疾病相关症状、应对能力、受益发现和生活质量。
作为中国康复期妇科恶性肿瘤患者的首个采用严格研究设计的随机对照试验，本研究将为微信平台在妇科恶性肿瘤康复期患者干预中的有效性提供证据。研究结果有助于进一步探讨基于微信的干预对改善患者焦虑和抑郁、疾病相关症状和生活质量的影响。
中国临床试验注册中心：ChiCTR2100053450，注册于 2021 年 11 月 21 日，http://www.chictr.org.cn/searchproj.aspx。
