A mHealth-based Nursing Model for the Health Outcomes of the Discharged Patients with Nasopharyngeal Carcinoma: a Pilot RCT


 Background: Nasopharyngeal carcinoma (NPC) is the most prevalent cancer in China, accounting for an incidence rate of 12.5/37 in Guangxi, which is the highest in the world. Although chemoradiotherapy offers more effective cancer treatment, it also causes a variety of acute and chronic side effects, seriously affecting the quality of life. NPC has evolved into a chronic disease with most patients opting for home-based rehabilitation. Therefore, efforts on improving the home-based extended care services to improve the quality of life of patients are booming. The Chinese government encourages the use of internet technology for expanding the prospect of nursing. Methods: An experimental design was applied for this study. The study enrolled 116 discharged patients who were re-examined in the Radiotherapy Department of the First Affiliated Hospital of Guangxi Medical University from November 2019 to February 2020. The patients were divided into a test and a control group (n = 58 cases in each group) using the IBM SPSS STATISTICS 20.0 random number generation method. The control group was subjected to routine discharge guidance and follow-up, while the experimental group was implemented with a mobile health (mHealth)-based continuous nursing intervention model. The scores of the side effects, cancer fatigue, and quality of life were compared between the two groups of patients for 3, 6, and 12 months, respectively after discharge from the hospital.Results: This study included a total of 114 patients, and there was no significant difference in the baseline data between the two groups. After 6 and 12 months of intervention, the severity of radiation toxicity and side effects, scores of cancer-related fatigue, and quality of life (symptom field) of the patients in the interventional group were significantly lowered statistically compared to those in the control group.Conclusion: This study is based on the mHealth continuous nursing intervention model, which can better guide discharged patients to master the correct rehabilitation nursing methods, and reduce the side effects of radiotherapy and cancer fatigue.Trial registration: This study was retrospectively registered as a randomized controlled trial in the Chinese Clinical Trial Center. Registration Date: January 12, 2021, Registration Number: ChiCTR2100042027.

Radiotherapy combined with chemotherapy is so far, the best treatment for NPC owing to characteristics like NPC cell differentiation and high sensitivity to radiation. The present 5-year overall survival rate in an NPC patient with such combinatorial treatment exceeds 80% (Jemal et al., 2011). However, chemoradiotherapy not only resists the tumor cells but also inevitably damages the normal tissues in the vicinity of the radiation eld area, resulting in acute and chronic radiation injury symptoms such as the oropharyngeal acute mucosal injury, dry mouth, taste change, di culty in opening the mouth and swallowing (Xiao et al., 2013; Yi & Qiang, 2017). These long-term toxicities and side effects syndrome tend to exist for a long time in the patients during the home rehabilitation period even after the treatment is terminated. It is during this post-treatment period that the body's symptoms group and the negative emotions cooperate and reinforce each other, aggravating the burden of cancer on the patients (Gift, Stommel, Jablonski, & Given, 2003). In addition, the nonstandard follow-up management, as well as the lack of access to health knowledge, seriously jeopardize the quality of life(QOL) of the NPC patients outside the hospital. Therefore, there is an urgent need for systematic and effective continuous nursing services to improve the correctness of the health behavior as well as meet the needs of personalized care (Chow, Wong, Chan, Chung, & Lee, 2010; Shi et al., 2015). Therefore, the NPC patients not only need to prolong their survival time but also medical staff to provide long-term, professional and timely continuing nursing services to improve their QOL.
Continuous care is considered one of the essential elements of high-quality health services (Min, Guohong, & Yang, 2015). It refers to the systematic, continuous, coordinated, and professional health care behavior that is conducive to the home-based rehabilitation of the patients in the unusual medical The implementation plan and operation process of continuous care in the hospital has no relevant theoretical guidance and standard, or uni ed evaluation system (Shi- services to the communities and families, and providing one-stop exible extension services for the discharged patients to meet their health needs (China, 2017). The research has shown that the e cient and convenient use of the internet, the follow-up management system can overcome limitations of time and space in traditionally implementing continuous nursing, accelerating the dissemination of health knowledge, improving the enthusiasm of the individual behavior and user experience, and thus, enable the patients to achieve a higher quality and effective management (Luo Huiyu, 2017).
Therefore, our team has used the internet technology to build a mHealth platform for the NPC patients relying on the WeChat public platform to provide them with good familial extended care. The aim involved exploring the impact of the mobile health care model on the health outcomes of the discharged NPC patients in terms of radiotherapy, fatigue, and quality of life.

Study design
This study is an exploratory pilot study based on a randomized controlled trial lasting from November 2019 to December 2020.

Patients
The study involved NPC patients who were recruited after reviewing in the Radiotherapy Department of the First A liated Hospital of Guangxi Medical University from November 2019 to February 2020.

Sample size calculation
According to the sample size calculation formula involving the comparison of the two sets of means, the sample size was calculated after consulting the literature, such that the two-sided α = 0.05, β = 0.10, and the proportion of the two groups of samples is the same, that is, r = 1. After preliminary experiments, the σ = 4.98,n c = 50 cases were calculated taking into account the 10-15% loss to follow-up rate, with n c = 58 cases, according to the average and standard deviation of the total score of cancer fatigue after 3 months of intervention for the two groups of patients. There were 58 cases in the control group. Therefore, a total of 116 cases were required.
The formula used is as follows: where r is the sample ratio of the two groups, u t and u c are the mean values of the two groups, σ2 is the combined variance, and n c is the sample size of the control group.

Randomization, assignment, and hiding
In this study, the IBM SPSS STATISTICS 20.0 random number generation method divided the patients into the experimental group and the control group with 58 cases each. (the IBM SPSS STATISTICS 20.0 software is a professional data statistical analysis software developed and continuously updated and improved by Norman H. Nie, C. Hadlai (Tex) Hull and Dale H. Bent, three graduate students from Stanford University in the United States.). After the participants expressed their interest in the research, the research recruiters used the IBM SPSS STATISTICS 20.0 software for randomized allocation. The researchers could not be blinded due to the inconsistent intervention tools between the two groups of patients. The allocation ratio of the intervention to control was 1:1.

The clinical teams
responsible for the operation of the whole team; the deputy leader was the head nurse, who assisted the whole team to carry out nursing. The members included 5 nursing staff of the radiotherapy department, 2 attending physicians, 1 graduate student, 1 dietitian, and 1 network engineer, with clear responsibilities assigned. (2) The team training: the training content involved the system platform and operation platform, the use and maintenance, data collection and input, the continuation of the nursing intervention methods, specialized nursing knowledge and techniques of the centralized and uni ed training, to ensure that the research and control the consistency of the implementation of prejudice, ensuring that every member is the master for platform operation, problem handling, and answering questions in the process of diagnosis and prognosis. (3) The responsibility and role allocation: the nursing members were responsible for the establishment of the patients' health records, formulation of the discharge plan, knowledge push, answer questions. The doctors participated in the formulation of follow-up plans for patients discharged from the hospital and answered questions online.

Intervention measures
Control group: There was routine discharge guidance and follow-up by the department follow-up staff every 3 months through telephone follow-up and outpatient follow-up guidance for understanding the side effects of the radiotherapy in the patients after discharge, and providing diet, oral care, functional exercise, follow-up, and other instructions. Experimental group: Based on the mobile health care model. detailed as follows:

Construction of the mobile health (mHealth)-platform
Mobile health (mHealth) was developed by a uni ed team of experts comprising those from the Radiation Oncology Department of the First A liated Hospital of Guangxi Medical University and an information technology company. According to the needs of the patients after discharge from the hospital, the characteristics of recovery, and the use of "Internet +" media technology, the research, and development was simple, and fully functional mobile health (mHealth) platform without installation. The platform architecture involved a system management platform and an operating platform. The system management platform had functions such as information management, data management, and platform maintenance. The operating platform: ran in the form of "WeChat Mini Program." Patient end: with functions of health knowledge base, online consultation, data upload, personalized management, and health le; Medical end: high-quality nursing resource sharing module; Patient library; Online clinic; Doctor information.
The details are as follows: (1) Service platform: A patient side: 1) Common interface: Knowledge database: it includes 5 types of knowledge for the patients to read and browse; Online consultation module: the patients can interact with the medical staff online to consult the basic knowledge of the disease, personalized dietary guidance, symptom management, emotional management, medication guidance, and other issues; Data upload module: used for collecting the patient's weight, blood routine, and other relevant health data, to facilitate the medical staff to timely grasp the patient's recovery. 2) Personal interface: My health les module: includes the basic information of the patients. Personalized demand knowledge module: the nursing team customized the personalized discharge plans and health education plans for the patients according to their nursing problems, complications assessment, and needs, and regularly sending them to the patients for 2 weeks ( Figure 1).
B Medical care side: The members of the continuous care team carried out the continuous care services through the functional modules customized at the medical care side. The medical side includes My patient database managed the patients who entered the home care platform, the patient's name, height, contact information, personal contact information, whether allergic drugs, and other information could be checked. Online q&A carried out the basic continuous care services, such as online q&A, providing the personalized guidance and health-related knowledge, operation guidance, reminder reading, and other follow-up content. The high-quality nursing resource sharing module: available on the public interface, the activities that could be browsed, technology development, and high-quality clinical nursing resources of our hospital, enriched the professional technical knowledge and improved the professional level ( Figure 2).
(2) System management platform: It has ve management modules: community management (the discharged patients in different regions), user management (medical care management and patient management), article and video, questionnaire, and statistical data management. The platform maintenance, and management, editing, updating, and pushing of health knowledge, questionnaire pushing, data statistical analysis, and other functions can be carried out according to the ve management modules ( Figure 3).

System security policy
The security of the platform: (1) Signing the con dentiality contracts with the technology developing companies to avoid breach of the patient privacy; (2) The use of cloud computing server, virtual rewall, role permission control, and other security operations. In addition, the managers should sign the relevant con dentiality agreements for software development, data transmission, and patient management for protecting patient privacy.

Application Security
The platform has both the function of authority and security management: hence, two levels of permissions are set in the medical terminal. The rst level of authority is the super administrator responsible for managing the account and password of the team members, the setting of patients' admission, as well as the operation and maintenance of the platform. The team members can join the medical terminal only after the super administrator grants the invitation code, and it is involved in the micro signal. To ensure security, others are barred from logging in to the medical terminal using their account. The second level of authority is involved those of the nursing team members responsible for regularly releasing video and audio health education materials, questionnaires, answering the questions of the patients. The patients and the families are only limited to use their rights. With the help of the security function of the WeChat software account management, information security was ensured since other accounts can't be logged in without the authorized permission.

Data access security
The platform was bound to a WeChat account and needed registration so that other accounts were barred from logging in ensuring the con dentiality of patient information; patients and families were only limited to use the rights and could only access the functions and contents that should be seen within their authority.

The intervention group
Before discharge: The patients in the intervention group were registered by scanning the QR code of the "mini-program" or following the "family continuation care" mini-program, and the electronic health records of the patients were established for improving the patient's health information: name, home address, mobile phone number, disease diagnosis, discharge time, current weight, etc. The operation of the platform being simple and easy to understand, ensured that patients would be pro cient in using all the functions (Figure 4).

After discharge
The intervention group implemented the nursing intervention based on the "Internet +" continuous nursing platform, based on the conventional nursing method of the control group, as follows (4) Personalized care: 1) According to the results of the individualized assessment, the symptoms, psychology, nutrition, and sleep problems of the patients were analyzed, The initiative to answer and guide online with words, pictures, and voice were taken, and the corresponding knowledge from the health education knowledge base were selected and the personalized knowledge module of patients were pushed timely, facilitating the patients to view, improve their knowledge reserve, meet their personalized nursing needs, and promote the patients to take effective health care behaviors.
2) Online interaction: the patients could browse the rehabilitation knowledge of "life care, disease knowledge, emotion management, symptom management" in the "health information module" of the "patient side"; if in doubt, they can consult with medical staff about the nursing knowledge through the "online consultation" module. The team members could click to view according to the message to answer and guide the patients' questions.
3) The continuous nursing team in the "My patient database" urged and instructed the patients to clock in and upload the exercise videos for functional exercises in cases where were mouth opening di culty and neck brosis every week to ensure the correctness of the nursing behaviors.
4) The patients were reminded to browse the latest published knowledge, monitor the reading volume of the patients in the background, and encourage and urge patients to actively and timely browse and self-learn.

5) Data upload:
This reminded the patients to upload the weight, blood index, and examination reports, which were convenient for the medical staff for consultation and guidance.
(5) Phased evaluation: The toxicity and side effects questionnaire, quality of life scale, and cancer fatigue scale were used to collect and evaluate the patients at 3, 6, and 12 months after the intervention, and the intervention scheme was continuously and dynamically optimized.
2.5 Instruments 2.5.1 General situation questionnaire It included the general baseline data (gender, age, occupation, education level, etc.) and disease data.
2.5.2 Toxic side effects of radiotherapy It was evaluated by the oncology Radiotherapy and RTOG Acute Radiation Injury Classi cation Standard. (Cox J D, 1995). The speci c rating criteria are as follows: (  Likert 4 rating methods are adopted for each item, and the score ranges from "no" to "persistent existence". The original score of each eld can be obtained by adding the scores of items included in each eld and dividing them by the number of items included.
Further, the range method is adopted to carry out a linear transformation, and the original score is converted into a standard score of 0~100 points, to make each eld comparative. The higher the score or the more problems in the seven symptom areas, the poorer the overall quality of life. The Cronbach's coe cient in all elds of the scale is ≥0.70, with good reliability and validity.

Data collection procedure
The general data, radiation toxicity and side effects, cancer fatigue, and quality of life scores of the patients in both the groups were collected by the members of the continuation nursing team before and after the intervention at 3, 6, and 12 months, respectively. Telephone follow-ups were utilized to collect information from the patients in the control group, and platform questionnaires or telephone follow-ups were used for collecting the patients in the intervention group.

Statistical analysis
The programs Microsoft Excel, and IBM statistics SPSS 20.0 were used for data entry as well as statistical description and analysis, respectively. The difference was statistically signi cant (P<0.05). The data following the normal distribution were expressed as mean ± standard deviation, and the counting data was expressed by the number of cases (%). The independent sample t -test and repeated measurement analysis of variance were used for measuring data, the chi -square test for counting data, and the nonparametric test for grade data.

Results
This study involved a total of 116 patients who were randomly allocated, with 58 patients each in the control and intervention groups (CONSORT Figure 5).
During the implementation of the project, there was one dropout in the control group due to the loss of follow-up, and one dropout in the intervention group due to distant metastasis. The total dropout rate was 1.72%. In the end, 57patients in the control and intervention groups completed the trial.

General data of the patients
There was a total of 114 patients comprising 57 in the control group and 57 in the intervention group. A chi-square test or independent -sample t -test compared the general data characteristics of the two groups, and the difference was not statistically signi cant (P > 0.05), indicating that the two groups were comparable. (Table 1)

Toxicities and side effects of radiotherapy before and after intervention
There was no signi cant difference between the two groups before the intervention (P > 0.05) (Table2). After 3 months of intervention, there was no signi cant difference in the severity of symptoms like dry mouth, nasal congestion, tinnitus, trismus, and neck brosis between the intervention and control groups (P > 0.05). After 6 and 12 months of intervention, the severity of the above symptoms like dry mouth, nasal congestion, tinnitus, trismus, and neck brosis in the intervention group was lower than those in the control group, and the difference was statistically signi cant (P < 0.05), (Table 3)

The cancer-related fatigue score before and after the intervention
There was no signi cant difference in the CRF score between the two groups before the intervention (P > 0.05). After 6 and 12 months of intervention, the scores of total fatigue, physical fatigue, emotional fatigue, and cognitive fatigue in the two groups were lower than those in the control group, with a statistical signi cance (P < 0.05). The results of the repeated measurement ANOVA with two samples showed that, extending the intervention time signi cantly lowered cancer in the two groups than that in the control group (P < 0.05). After 6 and 12 months of intervention, the score of the cancer fatigue in the intervention group was lowered than that in the control group (P < 0.05), (Table 4).

The quality of life symptom domain scores before and after the intervention
The symptom domains of quality of life between the two groups showed no signi cant difference in the scores before and after the intervention (P > 0.05).
After 6 months of intervention, the scores of head and neck pain, swallowing function, sensory problems, and language problems were found to be lowered in the intervention group than those in the control group (P < 0.05), while there was no signi cant difference in the other symptom scores (P > 0.05). After 12 months of intervention, the scores of symptom domains were found to be lower in the intervention group than those in the control group (P < 0.05); using the two -sample repeated measurement ANOVA, the results showed that except for the language problems, the scores of each symptom domain of quality of life lowered in the intervention group than those in the control group after 6 months and 12 months of intervention, and with the extension of the intervention time, the scores of symptom domains of the quality of life in the intervention group were found to decrease, (Table 5).  NPC as a chronic disease is highly prevalent in the old, rural, border, and poor areas of Guangxi (ZielińskaWięczkowska, 2010). After discharge, the patients, especially those in the rural areas, fail to achieve timely professional help and guidance from the medical personnel due to the long -distance or economic conditions. Dai has also proved that the discharged patients are more willing to receive professional guidance or one-to-one nursing service without leaving

The application of the mHealth management can reduce the incidence of toxic and side effects
The toxic and side effects of radiotherapy were found to be alleviated by effective nursing. This study showed that the application of the mHealth to carry out continuous nursing services can reduce the incidence of symptoms like nasal congestion, dry mouth, tinnitus, neck brosis, and di culty in the opening mouth (P < 0.05). Thus, the mHealth platform might be applicable for enlightening the patients with advanced knowledge of nursing, through dynamic video, and personalized counseling, that would effectively cater to the needs of the patients to get the nursing service and urge the patients to take effective nursing measures according to the inquiry function to improve their compliance and self-care skills, and nally reducing the symptoms like dry mouth, tinnitus, nasal congestion, and neck in the mouth. The degree of the side effects such as brosis and di culty in opening the mouth were also taken into consideration.  , 2003). This research is based on the mHealth to carry out continual nursing for NPC. The results showed that the scores of the 7 symptom areas of pain, swallowing, sensation, eating, language, social contact, and sexual function in the observation group were all lower than those in the control group after intervention (P < 0.05). In other words, the QOL of patients based on the extended care of network platform is better than the traditional follow-up management. This is similar to the research on applying "Internet +" in the chronic disease management model for type 2 diabetes by Yun(Hai-Ling, Ping, Wen-Xiu, & Xiao-Rong, 2016), and the results of Dai in designing and applying the networked management system for the stroke patients (JIA Jing, 2018). The reasons may be: (1), Combining the continuity of care with the "Internet +" to carry out the network management service would overcome the space and time constraints, and achieve seamless guidance and supervision, conducive to improve the health outcomes of the patients and improving the QOL of the patients. (2) The information management and emotional support can assist the patients in performing rehabilitation nursing and functional exercise, and that would reduce the degree of various speci c symptoms in the patients. The internet platform is always the carrier, and the most important factor for promoting the rehabilitation of the patients is the pertinence, rationality, and standardization of the content. (3) The "Internet +" continuity of care can effectively prevent the patients from returning to hospitals frequently, reducing the cost of medical services as well as the burden. (4) The continuity of care based on the "Internet +" is extended to home, and achieving the continuity of information, management and relationship.

Limitations
This study was a single-center study, and the number of included cases was relatively small. One of the inclusion criteria of the study subjects was the ability to use smartphones, and these limitations might affect the study results. In the future, the application of the platform can be further promoted and multicenter, large-sample application research should be performed to improve the credibility of the research.

Conclusion
This study provided professional, continuous, and overall extended care for the NPC discharged patients constructing the mHealth platform and implementing a continuous nursing scheme centered on the patient needs. The platform guides the patients to master the correct knowledge of the disease as well as the rehabilitation and exercise methods, for improving the self-care ability, reducing the toxic and side effects of radiotherapy and cancer fatigue, improving the QOL, and meeting the demands for long-term management. This study can provide reference for follow-up management of all patients with chronic diseases.  E-136)). If the patient met the inclusion criteria, the experts from the continuation care team would explain the purpose and process of the study to the patient, ensuring that their personal information is only used for this study. We con rmed that the participants understood the purpose of the trial and that is required of them during the informed consent process. Although the nursing staff was often present during the consent process, all the patients provided informed consent independently.
(3) Availability of data and material: The data that support the ndings of this study are not openly available due to human data and are available from the corresponding author upon reasonable request.
(4) Competing interests: The authors declare that they have no competing interests" in this section. (6) Authors' contributions: LTT implement of the research plan and analyzed and interpreted the patient data regarding the NPC disease and was a major contributor in writing the manuscript. YL is responsible for the quality review of the entire research program and statistical data. QLY is responsible for platform maintenance, implement of the research and statistical data; ZYX, ZJW and LJY are responsible for data collection. All authors read and approved the nal manuscript.  Access platform ow chart SupplementaryFileCONSORT.doc