TY  - JOUR
AU  - El Shafie, Rami A
AU  - Bougatf, Nina
AU  - Sprave, Tanja
AU  - Weber, Dorothea
AU  - Oetzel, Dieter
AU  - Machmer, Timo
AU  - Huber, Peter E
AU  - Debus, Jürgen
AU  - Nicolay, Nils H
PY  - 2018
DA  - 2018/03/06
TI  - Oncologic Therapy Support Via Means of a Dedicated Mobile App (OPTIMISE-1): Protocol for a Prospective Pilot Trial
JO  - JMIR Res Protoc
SP  - e70
VL  - 7
IS  - 3
KW  - mHealth
KW  - radiotherapy
KW  - mobile application
KW  - quality of life
KW  - cancer
KW  - Patient-Reported Outcome Measures (PROMs)
AB  - Background: The increasing role of consumer electronics and Web-enabled mobile devices in the medical sector opens up promising possibilities for integrating novel technical solutions into therapy and patient support for oncologic illnesses. A recent survey carried out at Heidelberg University Hospital suggested a high acceptance among patients for an additional approach to patient care during radiotherapy based on patient-reported outcomes by a dedicated mobile app. Objective: The aim of this trial (OPTIMISE-1: Oncologic Therapy Support Via Means of a Dedicated Mobile App – A Prospective Feasibility Evaluation) is to prospectively evaluate the feasibility of employing a mobile app for the systematic support of radiooncological patients throughout the course of their radiotherapy by monitoring symptoms and patient performance, and facilitating the background-exchange of relevant information between patient and physician. Methods: The present single-center, prospective, exploratory trial, conducted at Heidelberg University Hospital, assesses the feasibility of integrating an app-based approach into patient-care during radiotherapy. Patients undergoing curative radiotherapy for thoracic or pelvic tumors will be surveyed regarding general performance, treatment-related quality of life (QoL) and symptoms, and their need to personally consult a physician by means of a mobile app during treatment. The primary endpoint of feasibility will be reached when 80% of the patients have successfully answered 80% of their respective questions scheduled for each treatment day. Furthermore, treatment-related patient satisfaction and health-related QoL is assessed by the Patient Satisfaction Questionnaire Short Form (PSQ-18) and the European Organization for Research and Treatment of Cancer (EORTC) questionnaires at the beginning (baseline) and end of radiotherapy, and at the first follow-up. Results: This trial will recruit 50 patients over a period of 12 months. Follow-up will be completed after 18 months, and publication of results is planned at 24 months after trial initiation. Conclusions: This study will serve as a basis for future studies aiming to exploit the constant innovation in mobile medical appliances and integrate novel patient-centered concepts into patient care in the context of radiotherapy. Trial Registration: ClinicalTrials.gov NCT03168048; https://clinicaltrials.gov/ct2/show/NCT03168048 (Archived at WebCite http://www.webcitation.org/6wtWGgi0X) 
SN  - 1929-0748
UR  - https://www.researchprotocols.org/2018/3/e70/
UR  - https://doi.org/10.2196/resprot.8915
UR  - http://www.ncbi.nlm.nih.gov/pubmed/29510971
DO  - 10.2196/resprot.8915
ID  - info:doi/10.2196/resprot.8915
ER  -