Impact of a mobile health intervention based on Multi-theory model of health behavior change (MTM) on self-management in patients with differentiated thyroid cancer: protocol for a randomized controlled trial

Abstract

Abstract Introduction: The rapid development of modern network technology has led to the gradual popularization of online social software such as WeChat, and communication between patients and physicians has gradually shifted from offline to online, which has made the application of mHealth possible. Moreover, is evidence shown the use of mHealth interventions with patients can play an important role in the self-management of patients' diseases. Theoretical models of health behavior are important guides for disease prevention, detection, treatment, rehabilitation, as well as the promotion and maintenance of both physical and mental health, but there are no intervention studies related to DTC that use theoretical models of health as a guiding framework. This study aimed to MTM model to construct a health education intervention model for DTC patients, using a micro-letter platform as the intervention vehicle and mobile doctor-patient interactive health education as the means of intervention, to improve the health behaviors of DTC patients as well as the corresponding clinical outcomes. Methods This 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 received MTM-mHealth, and the realization of health education will rely on the smart terminal WeChat platform. Through the WeChat platform, physicians or professional nurses can realize timely health education interventions for patients, including daily reminders of taking medication, and popularization of science related to thyroid cancer. Routine discharge education will be given to the control group at discharge. Sociodemographic variables of patients will be collected at baseline, while clinical reagent tests and questionnaires will be completed at baseline as well as at 3 and 6 months of follow-up. The primary outcome will be change in TSH from baseline as well as 3 and 6 months of follow-up, and secondary outcomes will include change in self-management behavior, social cognitive and psychological, and metabolic control. Discussion This study will explore a feasible mHealth intervention program applied to a DTC patient population using the MTM theoretical model as a guide, with the goal 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 the self-management capabilities of DTC patients. The results of this study will indicate the feasibility as well as the effectiveness of the application of health theory model-based combined with mHealth application in disease prognostic health management model, provide a clinical basis for the mHealth intervention to assist the treatment plan related to the prognostic rehabilitation of oncology patients, and at the same time, provide policy recommendations and technology translation for the development of the application of mHealth management in the field of health management. Trial registration: Ethics Committee of the Fourth Affiliated Hospital of Harbin Medical University: 2022-WZYSLLSC-20; Clinical Trials: ChiCTR2200054321