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Prospective trial on telemonitoring of geriatric cancer patients using handheld devices

Prospektive Studie zum Telemonitoring mit Smartphones bei geriatrischen Krebspatienten

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Abstract

Purpose and objective

Randomized trials indicate that electronic or app-based assessment of patient-reported outcomes may improve outcomes in cancer patients. To analyze if an app-based follow-up would be accepted by elderly cancer patients, we conducted a single-center prospective feasibility study (NCT03196050).

Materials and methods

Cancer patients (≥60 years) without concurrent uncontrolled severe medical conditions and a Karnofsky performance status (KPS) ≥70 were eligible if they were able to use the smartphone app. The primary endpoint was compliance over 1 year, calculated as patient-specific and study date-specific response rate to questions sent as push notifications; in this interim analysis, we report on 4‑month data. Secondary outcomes included a comparison of a subjective health status item (SPHS) with the physician-rated KPS.

Results

Out of 225 patients screened, 54 patients agreed to participate and 29 activated the app and participated in the study. The mean age was 66 years (61–78). The individual compliance rate averaged at 58.3% (standard deviation SD = 35%). Daily compliance was 53.3% on average (SD = 10.8%) and declined over time. The average percentage of patients who sent answers at least weekly was 75.0% (SD = 14.8%) and declined from 100% in week 1 to 53.8% in week 17 post-enrollment. Secondary outcomes indicated that questionnaires such as the EORTC-QLQ-C30 are accepted via app and that there is a significant moderate correlation between the SPHS and KPS scores (r = 0.566; p < 0.001).

Conclusion

Our data indicate that an app-based follow-up incorporating EORTC questionnaires might be possible in highly selected elderly cancer patients with modest compliance rates. Further trials should aim at an increased participation rate.

Zusammenfassung

Hintergrund und Ziel

In randomisierten Studien konnte gezeigt werden, dass das elektronische Erfassen von „Patient-Reported-Outcomes“ die Therapieergebnisse bei Krebspatienten verbessern kann. Mit der monozentrischen prospektiven TeleGraPH-Studie untersuchten wir, ob eine appgestützte Nachbeobachtung von geriatrischen Krebspatienten machbar ist (NCT03196050).

Material und Methoden

Ältere Krebspatienten (≥60 Jahre) ohne schwere/unkontrollierbare Begleiterkrankungen und mit einem Karnofsky-Index (KPS) von ≥70 konnten eingeschlossen werden, sofern sie in der Lage waren, die Smartphone-App zu bedienen. Primärer Endpunkt war die Compliance über ein Jahr, berechnet als patientenspezifische sowie tagesspezifische Rücklaufquote gesendeter Anfragen an die Patienten. Im Rahmen dieser Interimsanalyse berichten wir über die initialen 4‑Monats-Ergebnisse. Sekundäre Endpunkte beinhalten den Vergleich des subjektiven Gesundheitsstatus (SPHS) mit dem ärztlich erfassten KPS.

Ergebnisse

Von 225 Patienten, die hinsichtlich der Studieneignung untersucht wurden, erklärten sich 54 bereit, teilzunehmen. Von diesen aktivierten nach detaillierter Aufklärung 29 Patienten mit einem mittleren Alter von 66 Jahren (Spanne 61–78 Jahre) die App und wurden eingeschlossen. Die individuelle Patienten-Compliance/Rücklaufquote lag bei 58,3 % (Standardabweichung SD = 35 %). Die tagesspezifische Rücklaufquote lag bei 53,3 % (SD = 10,8 %) und nahm im Studienverlauf ab. Die mittlere wochenspezifische Compliance, definiert als mindestens eine Rückmeldung pro Woche, lag bei 75,0 % (SD = 14,8 %) und reduzierte sich von 100 % in Studienwoche 1 auf 53,8 % in Studienwoche 17. Die Auswertung der sekundären Endpunkte ergab, dass der appbasierte EORTC-QLC-C30 von Patienten akzeptiert wird; weiterhin zeigt sich eine moderate signifikante Korrelation zwischen SPHS und KPS (r = 0,566; p < 0,001).

Schlussfolgerung

Unsere Daten deuten darauf hin, dass eine appbasierte Nachbeobachtung unter Einbeziehung von EORTC-Fragebögen bei älteren Krebspatienten mit akzeptabler Compliance möglich ist; zukünftige Studien sollten die Erhöhung der Teilnehmerrate zum Ziel haben.

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Acknowledgements

We thank all patients and their families for their participation in this trial. The excellent support of the clinical trial unit is gratefully acknowledged.

Funding

This study was funded by the H.W. & J. Hector Stiftung. The app was provided free of charge from Oncare GmbH (Munich, Germany). Additionally, parts of this project were supported by the Center for Innovative Care grant by the Baden-Wuerttemberg Ministry of Science, Research and Art (42-04HV.MED(18)/25/1).

Author information

Authors and Affiliations

  1. Department of Radiation Oncology, Universitätsmedizin Mannheim, Medical Faculty Mannheim, Heidelberg University, Theodor-Kutzer-Ufer 1–3, 68167, Mannheim, Germany

    Daniel Buergy, Victor Siefert, Christian Neumaier, Elena Sperk, Grit Welzel, Frederik Wenz & Frank Anton Giordano MD

  2. Heinrich-Lanz-Center for Digital Health, Medical Faculty Mannheim, University of Heidelberg, Mannheim, Germany

    Daniel Buergy & Thomas Ganslandt

  3. Experimental Radiation Oncology, Department of Radiation Oncology, Universitätsmedizin Mannheim, Medical Faculty Mannheim, Heidelberg University, Mannheim, Germany

    Manuel Blessing & Jürgen Hesser

  4. Central Institute for Scientific Computing (IWR), Heidelberg University, Heidelberg, Germany

    Manuel Blessing & Jürgen Hesser

  5. Central Institute for Computer Engineering (ZITI), Heidelberg University, Heidelberg, Germany

    Manuel Blessing & Jürgen Hesser

  6. Medical Center, University of Freiburg, Freiburg, Germany

    Frederik Wenz

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  1. Daniel Buergy
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Correspondence to Frank Anton Giordano MD.

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Conflict of interest

D. Buergy reports personal fees from Siemens AG, personal fees from NB Capital Research GmbH, personal fees from NB Capital ApS, and personal fees from b.e. Imaging GmbH outside the submitted work. E. Sperk reports grants, travel compensation, and personal fees from Carl Zeiss Meditec AG. G. Welzel reports non-financial support from Carl Zeiss Meditec AG outside the submitted work, and honoraria from Roche Pharma AG outside the submitted work. F. Wenz reports grants and personal fees from Elekta AB, Sweden, personal fees from Roche Pharma AG, grants, personal fees, and other from Carl Zeiss Meditec AG, personal fees from Celgene GmbH, personal fees from Eli Lilly and Company, and personal fees from Ipsen Pharma GmbH outside the submitted work. F.A. Giordano reports grants and personal fees from NOXXON Pharma AG, grants and personal fees from Carl Zeiss Meditec AG, personal fees from Bristol-Myers Squibb, personal fees from Roche Pharma AG, personal fees from MSD Sharp and Dohme GmbH, personal fees from AstraZeneca GmbH, grants and travel compensation from Elekta AB, and shares from Implacit GmbH. V. Siefert, C. Neumaier, T. Ganslandt, M. Blessing, J. Hesser, and G. Welzel, declare that they have no competing interests.

Additional information

D. Buergy and V. Siefert contributed equally to this article.

Caption Electronic Supplementary Material

66_2019_1548_MOESM1_ESM.docx

Supplementary Table 1 details questions and notifications sent to patients daily or every other day during the study period.

66_2019_1548_MOESM2_ESM.docx

Supplementary Table 2a, b details the results of the EORTC-QLQ-C30 functioning scales and the results of the EORTC-QLQ-C30 symptom scales.

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Buergy, D., Siefert, V., Neumaier, C. et al. Prospective trial on telemonitoring of geriatric cancer patients using handheld devices. Strahlenther Onkol 196, 205–212 (2020). https://doi.org/10.1007/s00066-019-01548-0

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  • DOI: https://doi.org/10.1007/s00066-019-01548-0

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