Dataset Information

Radiotherapy-related skin toxicity (RAREST-02): A randomized trial testing the effect of a mobile application reminding head-and-neck cancer patients to perform skin care (reminder app) on radiation dermatitis.

ABSTRACT: BACKGROUND:Radiotherapy of head-and-neck cancer can be associated with significant toxicities including dermatitis and oral mucositis. Severe toxicities may require interruptions of the radiation treatment associated with impairment of the patients' prognoses. This study will investigate whether the addition of a reminder app to standard care can reduce dermatitis and oral mucositis rates during radiotherapy in these patients. METHODS:This randomized trial compares standard care supported by a reminder app (Arm A) to standard care alone (Arm B) with respect to grade???2 radiation dermatitis and oral mucositis at 60 Gy of radiotherapy, the minimum planned dose for patients receiving definitive or adjuvant radiotherapy for locally advanced head- and-neck cancer. Moreover, radiation-induced dermatitis and oral mucositis grade???3 at 60 Gy and both grade???2 and grade???3 at the end of radiation treatment (EOT) will be evaluated, as well as quality of life and pain. According to sample size calculations, 80 patients are required per arm within the full analysis set. Taking into account that 5% of patients will not qualify for full analysis set, 168 patients should be randomized. The impact of the reminder app will be considered clinically relevant, if the rates of grade???2 radiation dermatitis (primary endpoint) and oral mucositis (secondary endpoint) can be reduced by 20%. DISCUSSION:If the addition of a reminder app to standard care will lead to a significant reduction of radiation dermatitis and oral mucositis, it could become a helpful tool for patients with head-and-neck cancer during radiotherapy. TRIAL REGISTRATION:clinicaltrials.gov (NCT04110977). Registered on September 27, 2019. First patient is planned to be included in December 2019.

SUBMITTER: Rades D

PROVIDER: S-EPMC7249413 | biostudies-literature | 2020 May

REPOSITORIES: biostudies-literature

ACCESS DATA

Publications

Radiotherapy-related skin toxicity (RAREST-02): A randomized trial testing the effect of a mobile application reminding head-and-neck cancer patients to perform skin care (reminder app) on radiation dermatitis.

Rades Dirk D Narvaez Carlos Andres CA Doemer Claudia C Janssen Stefan S Olbrich Denise D Tvilsted Soeren S Conde-Moreno Antonio J AJ Cacicedo Jon J

Trials 20200525 1

<h4>Background</h4>Radiotherapy of head-and-neck cancer can be associated with significant toxicities including dermatitis and oral mucositis. Severe toxicities may require interruptions of the radiation treatment associated with impairment of the patients' prognoses. This study will investigate whether the addition of a reminder app to standard care can reduce dermatitis and oral mucositis rates during radiotherapy in these patients.<h4>Methods</h4>This randomized trial compares standard care s ...[more]

PMID: 32450921

Similar Datasets

Project description:BackgroundConsumer electronics and Web-enabled mobile devices are playing an increasing role in patient care, and their use in the oncologic sector opens up promising possibilities in the fields of supportive cancer care and systematic patient follow-up.ObjectiveThe objective of our study was to assess the acceptance and possible benefits of a mobile app-based concept for supportive care of cancer patients undergoing radiotherapy.MethodsIn total, 975 patients presenting for radiotherapy due to breast or prostate cancer were screened; of them, 200 owned a smartphone and consented to participate in the survey. Patients were requested to complete a questionnaire at 2 time points: prior to the initiation (T0) and after the completion (T1) of radiotherapy. The questionnaire included questions about the habits of smartphone usage, technical knowledge and abilities of the participants, readiness to use a mobile app within the context of radiotherapy, possible features of the mobile app, and general attitude toward the different aspects of oncologic treatments. For quantitative analysis, sum scores were calculated for all areas of interest, and results were correlated with patient characteristics. Additionally, answers were quantitatively compared between time points T0 and T1.ResultsMedian patient age was 57 (range 27-78) years. Of the 200 participants, 131 (66.2%) reported having the ability to use their smartphones with minimal to no help and 75.8% (150/200) had not used their smartphones in a medical context before. However, 73.3% (146/200) and 83.4% (166/200) of patients showed a strong interest in using a mobile app for supportive care during radiotherapy and as part of the clinical follow-up, respectively. Patients most commonly requested functionalities regarding appointment scheduling in the clinic (176/200, 88.0%) and the collection of patient-reported outcome data regarding their illness, therapy, and general well-being (130/200, 65.0%). Age was identified as the most influential factor regarding patient attitude, with patients aged <55 years being significantly more inclined toward and versed in smartphone use (P<.001). The acceptance of mobile apps was significantly higher in patients exhibiting a Karnofsky performance index <80% (P=.01). Support in the context of therapy-related side effects was judged most important by patients with poor clinical performance (P=.006). The overall acceptance of mobile apps in the context of radiotherapy surveillance was high at a median item sum score of 71.4/100 and was not significantly influenced by tumor stage, age, gender, treatment setting, or previous radiotherapies.ConclusionsThe acceptance of mobile apps for the surveillance and follow-up of cancer patients undergoing radiotherapy is high; this high acceptance level will serve as a basis for future clinical trials investigating the clinical benefits of mobile app-based treatment support. Introduction of mobile apps into the clinical routine should be considered as an opportunity to improve and intensify supportive treatment for cancer patients.

Project description:The aim of the present trial is to investigate a new option of skin protection in order to reduce the rate of grade???2 skin toxicity in patients receiving radiotherapy alone or radiochemotherapy for locally advanced squamous cell carcinoma of the head-and-neck (SCCHN).This is a randomized, active-controlled, parallel-group multi-center trial that compares the following treatments of radiation dermatitis in patients with head-and-neck cancer: Mepitel® Film (Arm A) vs. standard care (Arm B). The primary aim of this trial is to investigate the rate of patients experiencing grade???2 radiation dermatitis (according to Common Toxicity Criteria for Adverse Events (CTCAE) Version 4.03) until 50 Gy of radiotherapy. Evaluation until 50 Gy of radiotherapy has been selected as the primary endpoint, since up to 50 Gy, the irradiated volume includes the primary tumor and the bilateral cervical and supraclavicular lymph nodes, and, therefore, is similar in all patients. After 50 Gy, irradiated volumes are very individual, depending on location and size of the primary tumor, involvement of lymph nodes, and the treatment approach (definitive vs. adjuvant). In addition, the following endpoints will be evaluated: Time to grade 2 radiation dermatitis until 50 Gy of radiotherapy, rate of patients experiencing grade???2 radiation dermatitis during radio(chemo)therapy, rate of patients experiencing grade???3 skin toxicity during radio(chemo)therapy, adverse events, quality of life, and dermatitis-related pain. Administration of Mepitel® Film will be considered to be clinically relevant, if the rate of grade???2 radiation dermatitis can be reduced from 85% to 65%.If administration of Mepitel® Film instead of standard care will be able to significantly reduce the rate of grade???2 radiation dermatitis, it could become the new standard of skin care in patients irradiated for SCCHN.clinicaltrials.gov NCT03047174 . Registered on 26th of January, 2017. First patient included on 9th of May, 2017.

Project description:The incidence of melanoma is increasing faster than any other major cancer both in Brazil and worldwide. Southeast Brazil has especially high incidences of melanoma, and early detection is low. Exposure to ultraviolet (UV) radiation is a primary risk factor for developing melanoma. Increasing attractiveness is a major motivation among adolescents for tanning. A medical student-delivered intervention that takes advantage of the broad availability of mobile phones and adolescents' interest in their appearance indicated effectiveness in a recent study from Germany. However, the effect in a high-UV index country with a high melanoma prevalence and the capability of medical students to implement such an intervention remain unknown.In this pilot study, our objective was to investigate the preliminary success and implementability of a photoaging intervention to prevent skin cancer in Brazilian adolescents.We implemented a free photoaging mobile phone app (Sunface) in 15 secondary school classes in southeast Brazil. Medical students "mirrored" the pupils' altered 3-dimensional (3D) selfies reacting to touch on tablets via a projector in front of their whole grade accompanied by a brief discussion of means of UV protection. An anonymous questionnaire capturing sociodemographic data and risk factors for melanoma measured the perceptions of the intervention on 5-point Likert scales among 356 pupils of both sexes (13-19 years old; median age 16 years) in grades 8 to 12 of 2 secondary schools in Brazil.We measured more than 90% agreement in both items that measured motivation to reduce UV exposure and only 5.6% disagreement: 322 (90.5%) agreed or strongly agreed that their 3D selfie motivated them to avoid using a tanning bed, and 321 (90.2%) that it motivated them to improve their sun protection; 20 pupils (5.6%) disagreed with both items. The perceived effect on motivation was higher in female pupils in both tanning bed avoidance (n=198, 92.6% agreement in females vs n=123, 87.2% agreement in males) and increased use of sun protection (n=197, 92.1% agreement in females vs n=123, 87.2% agreement in males) and independent of age or skin type. All medical students involved filled in a process evaluation revealing that they all perceived the intervention as effective and unproblematic, and that all pupils tried the app in their presence.The photoaging intervention was effective in changing behavioral predictors for UV protection in Brazilian adolescents. The predictors measured indicated an even higher prospective effectiveness in southeast Brazil than in Germany (>90% agreement in Brazil vs >60% agreement in Germany to both items that measured motivation to reduce UV exposure) in accordance with the theory of planned behavior. Medical students are capable of complete implementation. A randomized controlled trial measuring prospective effects in Brazil is planned as a result of this study.

Project description:ObjectiveThe objective of this study is to describe the algorithm and technical implementation of a mobile app that uses adaptive testing to assess an efficient mobile app for the diagnosis of delirium.Materials and methodsThe app was used as part of a NIH-funded project to assess the feasibility, effectiveness, administration time, and costs of the 2-step delirium identification protocol when performed by physicians and nurses, and certified nursing assistants (CNA). The cohort included 535 hospitalized patients aged 79.7 (SD = 6.6) years enrolled at 2 different sites. Each patient was assessed on 2 consecutive days by the research associate who performed the reference delirium assessment. Thereafter, physicians, nurses, and CNAs performed adaptive delirium assessments using the app. Qualitative data to assess the experience of administering the 2-step protocol, and the app usability were also collected and analyzed from 50 physicians, 189 nurses, and 83 CNAs. We used extensible hypertext markup language (XHTML) and JavaScript to develop the app for the iOS-based iPad. The App was linked to Research Electronic Data Capture (REDCap), a relational database system, via a REDCap application programming interface (API) that sent and received data from/to the app. The data from REDCap were sent to the Statistical Analysis System for statistical analysis.ResultsThe app graphical interface was successfully implemented by XHTML and JavaScript. The API facilitated the instant updating and retrieval of delirium status data between REDCap and the app. Clinicians performed 881 delirium assessments using the app for 535 patients. The transmission of data between the app and the REDCap system showed no errors. Qualitative data indicated that the users were enthusiastic about using the app with no negative comments, 82% positive comments, and 18% suggestions of improvement. Delirium administration time for the 2-step protocol showed similar total time between nurses and physicians (103.9 vs 106.5 seconds). Weekly enrollment reports of the app data were generated for study tracking purposes, and the data are being used for statistical analyses for publications.DiscussionThe app developed using iOS could be easily converted to other operating systems such as Android and could be linked to other relational databases beside REDCap, such as electronic health records to facilitate better data retrieval and updating of patient's delirium status.ConclusionOur app operationalizes an adaptive 2-step delirium screening protocol. Its algorithm and cross-plat formed code of XHTML and JavaScript can be easily exported to other operating systems and hardware platforms, thus enabling wider use of the efficient delirium screening protocol that we have developed. The app is currently implemented as a research tool, but with adaptation could be implemented in the clinical setting to facilitate widespread delirium screening in hospitalized older adults.

Project description:BACKGROUND: The use of mobile phones, and specifically smartphones, in the last decade has become more and more prevalent. The latest mobile phones are equipped with comprehensive features that can be used in health care, such as providing rapid access to up-to-date evidence-based information, provision of instant communications, and improvements in organization. The estimated number of health care apps for mobile phones is increasing tremendously, but previous research has highlighted the lack of critical appraisal of new apps. This lack of appraisal of apps has largely been due to the lack of clinicians with technical knowledge of how to create an evidence-based app. OBJECTIVE: We discuss two freely available methodologies for developing Web-based mobile phone apps: a website builder and an app builder. With these, users can program not just a Web-based app, but also integrate multimedia features within their app, without needing to know any programming language. METHODS: We present techniques for creating a mobile Web-based app using two well-established online mobile app websites. We illustrate how to integrate text-based content within the app, as well as integration of interactive videos and rich site summary (RSS) feed information. We will also briefly discuss how to integrate a simple questionnaire survey into the mobile-based app. A questionnaire survey was administered to students to collate their perceptions towards the app. RESULTS: These two methodologies for developing apps have been used to convert an online electronic psychiatry textbook into two Web-based mobile phone apps for medical students rotating through psychiatry in Singapore. Since the inception of our mobile Web-based app, a total of 21,991 unique users have used the mobile app and online portal provided by WordPress, and another 717 users have accessed the app via a Web-based link. The user perspective survey results (n=185) showed that a high proportion of students valued the textbook and objective structured clinical examination videos featured in the app. A high proportion of students concurred that a self-designed mobile phone app would be helpful for psychiatry education. CONCLUSIONS: These methodologies can enable busy clinicians to develop simple mobile Web-based apps for academic, educational, and research purposes, without any prior knowledge of programming. This will be beneficial for both clinicians and users at large, as there will then be more evidence-based mobile phone apps, or at least apps that have been appraised by a clinician.

Dataset Information

Radiotherapy-related skin toxicity (RAREST-02): A randomized trial testing the effect of a mobile application reminding head-and-neck cancer patients to perform skin care (reminder app) on radiation dermatitis.

Publications

Radiotherapy-related skin toxicity (RAREST-02): A randomized trial testing the effect of a mobile application reminding head-and-neck cancer patients to perform skin care (reminder app) on radiation dermatitis.

Similar Datasets

OmicsDI is part of the ELIXIR infrastructure

Tweets