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Thyroid cancer (TC) is one of the fastest growing cancers all over the world. Differentiated thyroid cancer (DTC) is the most frequent subtype of TC. When appropriate treatment is given, the prognosis for the patient is generally excellent. Despite the generally good prognosis of thyroid carcinomas, the symptoms may range from emotional to physical discomfort, depending on the thyroid hormone status, which can severely affect the patient. Moreover, the diagnostic and therapeutic procedures that DTC patients have to undergo, such as thyroidectomy and radioiodine therapy, significantly affect their mental and physical well-being. Often, the physician only addresses the favorable prognosis of DTC compared with other cancer types and neglects to assess issues related to the quality of life (QoL) of the patient; this was the reason we decided to design a mobile app for DTC patients and their caregivers.
The aim of this study is to research the feasibility and applicability of an mHealth app tailored to DTC patients, as reflected in their QoL. The main features of the developed app offer access to useful information about thyroid cancer, diagnostic tests, and the appropriate therapy administered to DTC patients.
Based on the existing literature, we created an up-to-date information platform regarding TC and especially DTC. In order to develop an effective app that can be implemented in current health care, we designed a section where the patient and physician can keep a medical record in an effort to enable access to such information at any time. Finally, we designed a user-friendly notification program, including pill prescription, follow-up tests, and doctor visit reminders in order to equally facilitate the lives of the patient and physician.
Having developed this mobile app, we aim to conduct a pilot quasiexperimental interventional trial. Our intention is to enroll at least 30 TC patients and assign them to intervention or control groups. Both groups will receive standard care for treating and monitoring TC, and the intervention group will also receive and use the DTC app. TC patients’ QoL will be assessed for both control and intervention groups in order to examine the effectiveness of the DTC app. QoL will be assessed through the QoL core questionnaire European Organisation for Research and Treatment of Cancer (EORTC) QLQ-THY34 in combination with the EORTC QLQ-C30 questionnaire through quantitative statistical analysis.
The use of mHealth apps can play a significant role in patient education, disease self-management, remote monitoring of patients, and QoL improvement. However, the main limitation of the majority of existing studies has been the lack of assessing their usefulness as well as the absence of specific instruments to carry out this assessment. In light of those considerations, we developed a mobile app tailored to the needs of DTC patients. Furthermore, we evaluated its contribution to the QoL of the patients by using the EORTC QLQ-THY34 questionnaire, an accurate and safe instrument for the evaluation of the QoL in TC patients, while supporting future planned endeavors in the field.
PRR1-10.2196/13409
Although thyroid cancer (TC) is a relatively rare neoplasm, accounting for approximately 1% to 5% of all cancers in females and less than 2% in males, it is the most common endocrine malignancy [
Surgery is the primary and most effective therapeutic approach for TC patients. Near total or total thyroidectomy with or without lymph node neck dissection is followed by radioiodine administration where appropriate. Thyroid stimulating hormone (TSH)-suppressive doses of thyroid hormone are administrated. This therapeutic management minimizes the risk of disease recurrence and metastatic spread while enabling accurate long-term surveillance. Systematic and targeted therapy is considered only for a small fragment of TC patients [
Proper patient education is of great importance as it ensures that the patient understands the potential side effects of their treatment. A patient who is informed and aware of all the side effects of the respective treatment is likely to be more tolerant of the treatment than an uniformed one [
The use of mobile phones and mHealth apps is constantly proliferating [
The primary objective of our study is to evaluate the design and implementation of an mHealth app tailored to DTC. This app aims to assist patients undergoing treatment for the management of malignant thyroid neoplasms by educating and motivating both them and their caregivers, facilitating maintenance of their medical record, and organizing their medication and appointments with their doctors. In order to examine the effectiveness of our intervention, we intend to conduct a quasiexperimental study assessing impact of the intervention on patient QoL as recorded in the EORTC QLQ-THY34 and EORTC QLQ-C30 questionnaires to reach accurate conclusions regarding the effectiveness of our app.
Our intention is to create an easy-to-use, accessible, and credible DTC app for patient QoL (
Screenshot of the DTC app home screen showing features Thyroid Info, Add Patient, Patient Info, and Add Reminder.
Τhe importance of proper information and education on TC patients’ effective disease management and therefore their prognosis, psychological status, and QoL is undisputed [
Thyroid Info feature comprises 8 chapters and references. Each chapter contains several questions so the patient can have the option to choose the topic they are interested in each time.
Screenshot of Thyroid Info feature content.
Screenshot of Thyroid Info feature content.
In the Add Patient panel, the patient or physician can add relevant demographic and clinical information and the results of any follow-up tests (
Screenshot of an Add Patient page. Registration can be done either in English or Greek.
The Add Reminder panel includes appointment organizer or reminder. This section was designed to serve as an appointment reminder and levothyroxine administration alert, enabling proper preparation for diagnostic and therapeutic procedures. The reminder will inform patient regarding when to withdraw thyroid hormone medication or rh-TSH injections in order to receive radioiodine for diagnostic or therapeutic purposes. Given that the volume of notifications received by users can be significant, we decided to use only a small number of notifications. When a patient visits the doctor, they can jointly arrange the next visit and prescribed medication and store this information in the app. In this context, we used Google’s Calendar API (application programming interface) to enable an organized display of the patient’s appointments and medication plans. The patient receives notifications for appointments a few days before the appointment and on the very day of the appointment. Regarding the medications, notifications are also used as a reminder. To best accommodate the needs of each patient, notifications can be edited.
The app was designed and developed in the Android Studio Development environment. The architecture used in this specific research study is a basic mobile architecture based on easy-to-use interface, system security, and data integrity. The app is easily deployable on any Android mobile platform, and plans are underway for the development of an iOS app. This app aims to provide a simple and intuitive interface, access to medical information (written by specialist doctors), and the ability to enable, store, and retrieve patient data (demographic and medical) in and from the cloud. The app also provides information to the user through notifications.
It is well known that the health care sector is extremely sensitive and has specific data protection requirements. Designing and developing a mobile app that contains sensitive patient data requires adherence to strict rules necessary to prevent unauthorized access to private information or personal data on the patient. It is also important to maintain updated log records for system failures. In view of the above, security has been one of our major concerns when designing and developing the DTC app. Data confidentiality and integrity has been ensured, while user and app authentication have been verified. This is the reason why we opted for cloud storage. Every data structure we store to the cloud is cryptographed. Tools such as hash functions, digital signatures, and symmetric and asymmetric keys are needed to achieve these features. Apart from that, we work on integrating the HL7 standards for the transfer of clinical and administrative data between software apps used by various health care providers.
Generally, the app design was geared to support the patient during treatment and management of DTC by informing and educating them. Furthermore, it was designed to empower them by keeping an up-to-date and easily accessible medical record while respecting their privacy, and providing reminders for medication and doctor appointments. Overall, the DTC mHealth app aims to become a key component in contributing to the improvement of patient QoL.
For this interventional study, we chose a quasiexperimental design to examine DTC patients’ QoL. The quasiexperimental approach was selected instead of the more rigorous randomized controlled trial (RCT) for two reasons. The first was the exploratory nature of this research since it is aiming to scope the features of such an app specifically pertaining to TC. The second is the necessity for credible but rapid results in order to iterate on the app itself. An RCT type of study is planned for a future iteration of the DTC app.
The main weaknesses of most of the previous studies regarding mHealth are the lack of assessment of the feasibility, usefulness, and effectiveness of mHealth apps and the lack of specific instruments for this assessment. As far as thyroid-related problems and functioning are concerned, only a few thyroid-specific QoL questionnaires have been developed. Moreover, we are informed assessments have been done largely using generic instruments. The EORTC created a TC-specific module to be used as a supplement to the QoL core questionnaire EORTC QLQ-C30 (phase I and II of the EORTC module development process) [
Patients will be recruited at the 3rd nuclear medicine department of Papageorgiou Hospital, Aristotle University of Thessaloniki, Greece, and the nuclear medicine department of Theagenio Cancer Hospital, Thessaloniki, Greece. A formal protocol of the study has been submitted and approved by the ethics committee of the Aristotle University of Thessaloniki (no 398/11.12.2017) that shall include written consent from the patients to use their pseudonymized data in a statistically aggregate manner while respecting their privacy. We aim to enroll at least 30 patients into two groups without randomization. The first group will be given the DTC app, while the rest of the patients will receive oral instructions and informative printed material. Both groups will undergo standard diagnostic and therapeutic procedures the DTC patients receive. The inclusion criteria for patient participation in the intervention group are having undergone thyroidectomy, diagnosis of DTC, radioiodine treatment medically indicated, possession of mobile phone or tablet supporting Android software, and the ability to use Android apps. The control group will have similar demographic and clinical characteristics.
For both groups there will be recorded demographic and clinical characteristics. As far as the intervention group is concerned, the data will be recorded by the nuclear medicine physician either via the DTC app on the patient’s mobile device or the physician’s personal computer. Following that, data will be exported in Excel (Microsoft Corp) files and stored in SPSS Statistics 25.0.0.0 (IBM Corp). Control group data will be recorded in Excel files and then stored in SPSS Statistics 25.0.0.0. Patients of both groups will be given the EORTC QLQ-THY34 and EORTC QLQ-C30 questionnaires to examine their QoL. This is the only instrument in the native language of the patients, developed by the EORTC QoL Group. The EORTC QoL module for TC consists of 34 items and is currently being pilot-tested for the final international field validation in phase IV. It will be available in the following languages: Arabic, Chinese, Dutch, English, French, German, Greek, Hebrew, Hindi, Japanese, Italian, Polish, Portuguese, and Tamil [
All data will be downloaded and stored in SPSS Statistics. Descriptive statistics will be used to characterize the overall sample, each condition, and study acceptability and demand. To examine preliminary differences in feasibility, we will use chi-square tests, Fisher exact tests, and nonparametric Mann-Whitney
Clinical evolution questions and diagnostic markers shall be checked for possible psychological effects of better information (eg, question 34: Have you experienced any throat ache?). However, the respective analysis shall focus on questions describing both the emotional disposition of the patient (eg, Did you feel distressed or irritated?) and their perceptions about the quality of care provided (eg, Did you feel well supported by your doctors?). The hypothesized scales assessed for our patients through the questionnaires are anxiety, body image, cramps, discomfort in the head and neck, dry mouth, fatigue, hair, impact on job or education, joint paint, neuropathological problems, restlessness, shoulder functioning, social support, swallowing, temperature tolerance, voice, and worries about important others.
TC is a malignant neoplasm with excellent prognosis in cases where appropriate treatment is given. The standard therapeutic interventions, their preparation, possible complications or adverse events, and numerous diagnostic and follow-up tests that TC patients must undergo may severely affect their QoL. Evidence-based medicine, a more personalized patient approach, novel management strategies such as the use of rh-TSH, and proper patient education are intended to ensure QoL. The use of mHealth apps—currently proliferating—can play a significant role in patient education, disease self-management, and remote monitoring of patients, thus resulting in an improvement in their QoL. There have been already several papers and reviews on the topic of mHealth addressed in conjunction with chronic diseases and, more specifically, with cancer. However, the key weakness of most of the studies to date has been the lack of assessing their usefulness and specific instruments used in the assessment. In this context, we attempted to develop a mobile app tailored to DTC patients and evaluate its contribution to patient QoL by using the EORTC QLQ-THY34 questionnaire. To the best of our knowledge, the QLQ-THY34 questionnaire is the most accurate and safe instrument to evaluate QoL in TC patients and is also under validation and translated in Greek, which ensures the validity of our results on the effectiveness of the DTC app.
The work described here is a precursor to a planned RCT endeavor on the impact of such solutions on the overall QoL aspect of cancer survivorship, an active and open research endeavor. This work aims to assess how effective the app is regarding the improvement of QoL of these patients (soon to be considered as productive and healthy individuals), evaluate the DTC mHealth solution regarding the patient’s access to medical information, and provide moral support during and after treatment. This shall be achieved with validated evaluation instruments through accepted common practices at two of the largest hospitals in Greece. This quasiexperimental study shall provide evidence-based feedback for the iterative refinement of this mHealth solution and support future planned endeavors and research in the field.
application programming interface
differentiated thyroid cancer
European Organisation for Research and Treatment of Cancer
mobile health
quality of life
randomized controlled trial
recombinant thyroid stimulating hormone
thyroid cancer
thyroid stimulating hormone
We would like to express our gratitude to the Medical Physics Department of Aristotle University of Thessaloniki, Greece, for its financial contribution for covering the publishing fee.
None declared.