Data_Sheet_1_Impact of a mobile health intervention based on multi-theory model of health behavior change on self-management in patients with differentiated thyroid cancer: protocol for a randomized controlled trial.DOC

IntroductionTheoretical models of health behavior are important guides for disease prevention and detection, treatment and rehabilitation, and promotion and maintenance of physical and mental health, but there are no intervention studies related to differentiated thyroid cancer (DTC) that use theoretical models of health as a guide. In this study, we used a microblogging platform as an intervention vehicle and mobile patient-doctor interactive health education as a means of intervention, with the aim of improving the health behaviors of DTC patients as well as the corresponding clinical outcomes.MethodsThis research project is a quantitative methodological study, and the trial will be a single-blind, single-center randomized controlled trial conducted at the Fourth Hospital of Harbin Medical University in Harbin, Heilongjiang Province. The study subjects are patients over 18 years of age with differentiated thyroid cancer who were given radioactive iodine-131 therapy as well as endocrine therapy after radical surgery for thyroid cancer. The intervention group will receive MTM-mhealth, and the realization of health education will rely on the smart terminal WeChat platform. Routine discharge education will be given to the control group at discharge. The primary outcome will be change in thyroid-stimulating hormone (TSH) from baseline and at 3 and 6 months of follow-up, and secondary outcomes will include change in self-management behavior, social cognitive and psychological, and metabolic control.DiscussionThis study will explore a feasible mHealth intervention program applied to a population of DTC patients using the Multi-theory model of health behavior change (MTM) as a guide, with the aim of evaluating the MTM-based intervention program for clinical outcome improvement in DTC patients, as well as determining the effectiveness of the MTM-based intervention program in improving self-management skills in DTC patients. The results of this study will indicate the feasibility as well as the effectiveness of the application of health theoretical modeling combined with mHealth applications in disease prognostic health management models, and provide policy recommendations and technological translations for the development of mobility-based health management applications in the field of health management.

引言：健康行为理论模型对于疾病的预防与检测、治疗与康复，以及身心健康的促进与维护具有重要意义。然而，目前尚无针对分化型甲状腺癌（DTC）的干预研究，该研究采用健康行为理论模型作为指导。本研究以微博平台作为干预工具，以移动患者-医生互动健康教育作为干预手段，旨在改善DTC患者的健康行为及其相应的临床结局。方法：本研究是一项定量方法学研究，试验将在黑龙江省哈尔滨市哈尔滨医科大学第四医院进行单盲、单中心的随机对照试验。研究对象为年龄超过18岁的分化型甲状腺癌患者，在接受甲状腺癌根治手术后，接受了放射性碘-131治疗及内分泌治疗。干预组将接受MTM-mhealth，健康教育将通过智能终端微信平台实现。对照组将在出院时接受常规出院教育。主要结局指标为基线及随访3个月和6个月时甲状腺刺激素（TSH）的变化，次要结局指标包括自我管理行为、社会认知和心理以及代谢控制的变化。讨论：本研究旨在探讨以健康行为改变的多理论模型（MTM）为指导，针对DTC患者人群的应用mHealth干预方案，以评估基于MTM的干预方案对DTC患者临床结局改善的效果，以及确定基于MTM的干预方案在提高DTC患者自我管理技能方面的有效性。本研究结果将指出将健康理论模型与mHealth应用相结合在疾病预后健康管理模型中的可行性和有效性，并为健康管理领域基于移动性的健康管理应用的发展提供政策建议和技术转化。