An App to Identify Radiation Pneumonitis - a Pre-Study in Healthy Volunteers (POLCAR-HV)

Lung cancer belongs to the most common types of solid cancer in Europe and Northern America. Most patients with small-cell lung cancer receive radiotherapy in combination with chemotherapy as definitive treatment. Also, a considerable number of patients with advanced non-small-cell lung cancer are treated with radiotherapy with or without concurrent chemotherapy. Radiation pneumonitis is a possible side effect of radiotherapy for lung cancer. Severe pneumonitis was reported to be fatal in approximately 2% of patients experiencing this adverse event. Pneumonitis may occur only several weeks or even months following radiotherapy. The symptoms may not be associated with the previously administered radiation treatment, and pneumonitis may be missed. Symptoms of pneumonitis generally include cough, shortness of breath, and fever. In a previous prospective trial (PARALUC), a scoring system was developed to contribute to a more precise and earlier detection of symptomatic radiation pneumonitis (grade ≥2) after radiotherapy for lung cancer. In that trial, 0 to 3 scoring points were assigned to each of the three symptoms mentioned above. Thus, patient scores ranged between 0 and 9 points. The optimal cut-off score for identification of pneumonitis was found to be 5 points. Moreover, an increase by 3 or more points from the baseline score was significantly associated with pneumonitis. Since the PARALUC trial was performed in lung cancer patients of any age, it was not clear whether its results were applicable to elderly patients known to have a higher risk of developing pneumonitis. Therefore, the POLCAR trial was performed in lung cancer patients aged ≥65 years. In that trial, the optimal cut-off score for identification of pneumonitis was 4 points, and an increase by 2 or more points compared to baseline was associated with pneumonitis. Based on the results from the PARALUC and the POLCAR trial, an app (PneumoCheck) was developed. Before this app can be tested in a prospective trial involving patients, its usability needs to be evaluated by healthy volunteers. In the present prospective study, 30 healthy volunteers test and rate ten aspects related to the usability of the app.

This is a prospective multi-center study (one arm), which is performed in 30 healthy volunteers. Inclusion criteria are possession of and ability to use a smart phone, age of at least 18 years, written informed consent, and capacity of the participant to consent. Patients with expected non-compliance will not be included. The healthy volunteers have to download the PneumoCheck app, which has been designed by the Lübeck based company Nextlabel OHG. After receiving the link for the download of the app from Nextlabel OHG by e-mail, the participants are asked to test the app and complete a questionnaire. They are asked to affirm or negate ten statements in three sections (download and installation, navigation, and content/functions) regarding the usability of the app. Recruitment of all participants should be completed within 1 month. The study for each participant takes only 1 day. Thus, the expected total running time for this study is 1 month. The primary objective of this study is to evaluate the usability of the PneumoCheck app designed to identify radiation pneumonitis in lung cancer patients. Primary endpoint is satisfaction with the PneumoCheck app. In addition, iPhone and Android users will be compared.

The participants have to download the app, which has been designed by the Luebeck based company Nextlabel OHG. After receiving the link for the download of the app from Nextlabel OHG by e-mail, the participants are asked to test the app and complete a questionnaire (according to previous studies, Appendix III). They are asked to affirm or negate ten statements in three sections (download and installation, navigation, and content/functions) regarding the usability of the app. The satisfaction rate represents the rate of participants who affirmed a statement. If this rate was <60%, the app was rated as not being useful. If the rate was between ≥60% but <80%, the app was regarded useful but required further optimization regarding the corresponding section. In addition, iPhone and Android users are compared with respect to the satisfaction rates (Fisher's exact tests).