Maintenance Notice

Due to necessary scheduled maintenance, the JMIR Publications website will be unavailable from Wednesday, July 01, 2020 at 8:00 PM to 10:00 PM EST. We apologize in advance for any inconvenience this may cause you.

Who will be affected?

Accepted for/Published in: Journal of Medical Internet Research

Date Submitted: Feb 2, 2023
Date Accepted: Jul 24, 2023

The final, peer-reviewed published version of this preprint can be found here:

App-Controlled Treatment Monitoring and Support for Patients With Head and Neck Cancer Undergoing Radiotherapy: Results From a Prospective Randomized Controlled Trial

Sprave T, Pfaffenlehner M, Stoian R, Cristofi E, Rühle A, Zöller D, Fabian A, Fahrner H, Binder H, Schäfer H, Gkika E, Grosu AL, Heinemann F, Nicolay NH

App-Controlled Treatment Monitoring and Support for Patients With Head and Neck Cancer Undergoing Radiotherapy: Results From a Prospective Randomized Controlled Trial

J Med Internet Res 2023;25:e46189

DOI: 10.2196/46189

PMID: 37856185

PMCID: 10623226

App-controlled treatment monitoring and support for head and neck cancer patients undergoing radiotherapy: results from a prospective randomized controlled trial

  • Tanja Sprave; 
  • Michelle Pfaffenlehner; 
  • Raluca Stoian; 
  • Eleni Cristofi; 
  • Alexander Rühle; 
  • Daniela Zöller; 
  • Alexander Fabian; 
  • Harald Fahrner; 
  • Harald Binder; 
  • Henning Schäfer; 
  • Eleni Gkika; 
  • Anca-Ligia Grosu; 
  • Felix Heinemann; 
  • Nils Henrik Nicolay

ABSTRACT

Background:

Head-and-neck cancers (HNCs) are very common malignancies, and treatment often requires multimodality approaches including radiotherapy and chemotherapy. HNC patients often display a high symptom burden, both due to disease itself and the required multimodal therapy. Close telemonitoring of symptoms and quality-of-life during the course of treatment may help to identify those HNC patients requiring early medical support.

Objective:

The App-Controlled Treatment Monitoring and Support for Head-and-Neck Cancer Patients (APCOT) trial aimed to investigate the feasibility of integrating electronic patient-reported outcome (ePROs) in the treatment surveillance pathway of HNC patients during the course of their radiotherapy. Additionally, the influence of app-based ePRO monitoring on global and disease-specific quality-of-life and patient satisfaction with treatment was assessed.

Methods:

Patients undergoing radiotherapy for histologically proven HNCs at the Department of Radiation Oncology, University Medical Center Freiburg, Germany, were enrolled in this trial and monitored by weekly physician appointments. Patients were randomized between additional ePRO monitoring on each treatment day or standard-of-care. Feasibility of ePRO monitoring was defined for ≥80% of enrolled patients answering ≥80% of their daily app-based questions. Quality-of-life and patient satisfaction were assessed by the European Organisation for Research and Treatment of Cancer QLQ-C30 questionnaire and H&N35 module and the validated Patient Satisfaction Questionnaire Short Form (PSQ-18) at the completion of treatment and compared between trial arms.

Results:

100 patients were enrolled in this trial, and 93 patients were evaluable. All patients in the experimental arm (100%) answered ≥80% of ePRO questions during treatment, reaching the pre-defined threshold for feasibility of ePRO monitoring (p<0.001, binomial test). No clinical or patient-specific factor was found to influence feasibility. Global health and most domains of general quality-of-life were comparable between trial arms, but an increased head-and-neck cancer-specific symptom burden was reported by patients undergoing ePRO surveillance. Improved patient satisfaction parameters interpersonal manner (p=0.01), financial aspects (p=0.01) and time spent with doctor (p=0.01) were reported in patients in whom ePROs were monitored.

Conclusions:

This trial demonstrated the feasibility of integrating daily app-based ePRO surveillance in head-and-neck cancer patients undergoing radiotherapy. Telemonitoring in this setting increased reporting of head-and-neck cancer-specific symptom burden and significantly improved several domains of patient satisfaction. Further analyses are needed to assess whether our findings hold true outside the context of a clinical trial. Clinical Trial: German Clinical Trials Register (DRKS00020491)


 Citation

Please cite as:

Sprave T, Pfaffenlehner M, Stoian R, Cristofi E, Rühle A, Zöller D, Fabian A, Fahrner H, Binder H, Schäfer H, Gkika E, Grosu AL, Heinemann F, Nicolay NH

App-Controlled Treatment Monitoring and Support for Patients With Head and Neck Cancer Undergoing Radiotherapy: Results From a Prospective Randomized Controlled Trial

J Med Internet Res 2023;25:e46189

DOI: 10.2196/46189

PMID: 37856185

PMCID: 10623226

Download PDF


Request queued. Please wait while the file is being generated. It may take some time.

© The authors. All rights reserved. This is a privileged document currently under peer-review/community review (or an accepted/rejected manuscript). Authors have provided JMIR Publications with an exclusive license to publish this preprint on it's website for review and ahead-of-print citation purposes only. While the final peer-reviewed paper may be licensed under a cc-by license on publication, at this stage authors and publisher expressively prohibit redistribution of this draft paper other than for review purposes.