Oncologic Therapy Support Via Means of a Dedicated Mobile App (OPTIMISE-1): Protocol for a Prospective Pilot Trial

Rami A El Shafie, Nina Bougatf, Tanja Sprave, Dorothea Weber, Dieter Oetzel, Timo Machmer, Peter E Huber, Jürgen Debus, Nils H Nicolay, Rami A El Shafie, Nina Bougatf, Tanja Sprave, Dorothea Weber, Dieter Oetzel, Timo Machmer, Peter E Huber, Jürgen Debus, Nils H Nicolay

Abstract

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://ichgcp.net/clinical-trials-registry/NCT03168048 (Archived at WebCite http://www.webcitation.org/6wtWGgi0X).

Keywords: Patient-Reported Outcome Measures (PROMs); cancer; mHealth; mhealth; mobile application; quality of life; radiotherapy.

Conflict of interest statement

Conflicts of Interest: TM holds shares in OPASCA GmbH (Mannheim, Germany). All other authors declare that they have no competing interests.

©Rami A El Shafie, Nina Bougatf, Tanja Sprave, Dorothea Weber, Dieter Oetzel, Timo Machmer, Peter E Huber, Jürgen Debus, Nils H Nicolay. Originally published in JMIR Research Protocols (http://www.researchprotocols.org), 06.03.2018.

Figures

Figure 1
Figure 1
Time-line for trial subjects. Endpoints are marked in red. EORTC QoL questionnaire: European Organisation for Research and Treatment of Cancer quality of life questionnaire.
Figure 2
Figure 2
Sample screenshot of the mobile application for patient support during radiotherapy.

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