Feasibility of evaluating AI-enabled digital symptom monitoring in metastatic patients with NSCLC receiving pembrolizumab therapy: A German single-arm observational pilot study

Introduction Close symptom monitoring can benefit patients with metastatic nonsmall cell lung cancer (mNSCLC) receiving first-line therapy. Remote patient monitoring technologies, like the artificial intelligence (AI)-enabled Kaiku ® Health platform that allows oncology patients to report their heal...

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Main Authors: Melissa L. Santorelli, Oliver Schmalz, Mathias Hoiczyk, David Heigener, Clemens Schulte, Markus Knott, Petra Hoffknecht, Joonas Vainio, Thomas Burke, Josephine M. Norquist, Sabine Riehl, Alexander Hildner, Lisa Barthuber, Sabine Bohnet
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Language:English
Published: SAGE Publishing 2025-07-01
Series:Digital Health
Online Access:https://doi.org/10.1177/20552076251348584
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author Melissa L. Santorelli
Oliver Schmalz
Mathias Hoiczyk
David Heigener
Clemens Schulte
Markus Knott
Petra Hoffknecht
Joonas Vainio
Thomas Burke
Josephine M. Norquist
Sabine Riehl
Alexander Hildner
Lisa Barthuber
Sabine Bohnet
author_facet Melissa L. Santorelli
Oliver Schmalz
Mathias Hoiczyk
David Heigener
Clemens Schulte
Markus Knott
Petra Hoffknecht
Joonas Vainio
Thomas Burke
Josephine M. Norquist
Sabine Riehl
Alexander Hildner
Lisa Barthuber
Sabine Bohnet
author_sort Melissa L. Santorelli
collection DOAJ
description Introduction Close symptom monitoring can benefit patients with metastatic nonsmall cell lung cancer (mNSCLC) receiving first-line therapy. Remote patient monitoring technologies, like the artificial intelligence (AI)-enabled Kaiku ® Health platform that allows oncology patients to report their health status in real-time to healthcare providers, may enhance patients’ treatment experience. Methodology The lung artificial intelligence-enabled digital solution pilot study (“Lung AID”) assessed the feasibility of future studies on Kaiku ® Health in patients with mNSCLC receiving first-line pembrolizumab in Germany. Patient engagement with Kaiku ® Health and practicality of collecting patient-reported outcomes (PROs) via the separate Lung AID EDC system were assessed by platform access rates. Kaiku ® Health access required one login, while Lung AID EDC access required submission of ≥1 PRO questionnaire. Post hoc analyses explored access by site experience with Kaiku ® Health. Results Over a 17-month enrollment period, 47 of 100 planned patients were enrolled in the study. Kaiku ® Health was accessed by 85.1% of patients, with higher engagement at experienced sites (96.2%). Only 38.3% accessed the Lung AID EDC system; 31.9% used both systems. Discussion High Kaiku ® Health access rates imply patient interest in remote digital monitoring for mNSCLC. However, recruitment challenges and use of a separate system to collect PRO data demonstrated difficulties in assessing the feasibility of these technologies in real-world settings. Our results highlight the need for streamlined patient monitoring tools and enhanced site and patient engagement strategies. Conclusion While definitive conclusions on future studies cannot be drawn, the study offers key insights into challenges that should be considered in future research.
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spelling doaj-art-86d42dcf54964b13a75fe311ed6ae6d42025-08-20T03:50:53ZengSAGE PublishingDigital Health2055-20762025-07-011110.1177/20552076251348584Feasibility of evaluating AI-enabled digital symptom monitoring in metastatic patients with NSCLC receiving pembrolizumab therapy: A German single-arm observational pilot studyMelissa L. Santorelli0Oliver Schmalz1Mathias Hoiczyk2David Heigener3Clemens Schulte4Markus Knott5Petra Hoffknecht6Joonas Vainio7Thomas Burke8Josephine M. Norquist9Sabine Riehl10Alexander Hildner11Lisa Barthuber12Sabine Bohnet13 Merck & Co., Inc., Rahway, NJ, USA HELIOS Universitätsklinikum Wuppertal, Klinik für Hämatologie, Onkologie und Palliativmedizin, Wuppertal, Germany Medizinisches Versorgungszentrum (MVZ) Marien-Hospital-Wesel GmbH, Wesel, Germany , Rotenburg, Germany Gemeinschaftspraxis für Hämatologie und Onkologie, Gefos Dortmund mbH, Dortmund, Germany Stuttgart Cancer Center, Klinikum der Landeshauptstadt Stuttgart gKAöR, Stuttgart, Germany Medizinisches Versorgungszentrum (MVZ) II - Onkologie und Hämatologie, MVZ Niels-Stensen-Kliniken, Georgsmarienhütte, Germany , Helsinki, Finland Merck & Co., Inc., Rahway, NJ, USA Merck & Co., Inc., Rahway, NJ, USA , Gießen, Germany , Gießen, Germany , Munich, Germany UKSH, Campus Lübeck, Lübeck, GermanyIntroduction Close symptom monitoring can benefit patients with metastatic nonsmall cell lung cancer (mNSCLC) receiving first-line therapy. Remote patient monitoring technologies, like the artificial intelligence (AI)-enabled Kaiku ® Health platform that allows oncology patients to report their health status in real-time to healthcare providers, may enhance patients’ treatment experience. Methodology The lung artificial intelligence-enabled digital solution pilot study (“Lung AID”) assessed the feasibility of future studies on Kaiku ® Health in patients with mNSCLC receiving first-line pembrolizumab in Germany. Patient engagement with Kaiku ® Health and practicality of collecting patient-reported outcomes (PROs) via the separate Lung AID EDC system were assessed by platform access rates. Kaiku ® Health access required one login, while Lung AID EDC access required submission of ≥1 PRO questionnaire. Post hoc analyses explored access by site experience with Kaiku ® Health. Results Over a 17-month enrollment period, 47 of 100 planned patients were enrolled in the study. Kaiku ® Health was accessed by 85.1% of patients, with higher engagement at experienced sites (96.2%). Only 38.3% accessed the Lung AID EDC system; 31.9% used both systems. Discussion High Kaiku ® Health access rates imply patient interest in remote digital monitoring for mNSCLC. However, recruitment challenges and use of a separate system to collect PRO data demonstrated difficulties in assessing the feasibility of these technologies in real-world settings. Our results highlight the need for streamlined patient monitoring tools and enhanced site and patient engagement strategies. Conclusion While definitive conclusions on future studies cannot be drawn, the study offers key insights into challenges that should be considered in future research.https://doi.org/10.1177/20552076251348584
spellingShingle Melissa L. Santorelli
Oliver Schmalz
Mathias Hoiczyk
David Heigener
Clemens Schulte
Markus Knott
Petra Hoffknecht
Joonas Vainio
Thomas Burke
Josephine M. Norquist
Sabine Riehl
Alexander Hildner
Lisa Barthuber
Sabine Bohnet
Feasibility of evaluating AI-enabled digital symptom monitoring in metastatic patients with NSCLC receiving pembrolizumab therapy: A German single-arm observational pilot study
Digital Health
title Feasibility of evaluating AI-enabled digital symptom monitoring in metastatic patients with NSCLC receiving pembrolizumab therapy: A German single-arm observational pilot study
title_full Feasibility of evaluating AI-enabled digital symptom monitoring in metastatic patients with NSCLC receiving pembrolizumab therapy: A German single-arm observational pilot study
title_fullStr Feasibility of evaluating AI-enabled digital symptom monitoring in metastatic patients with NSCLC receiving pembrolizumab therapy: A German single-arm observational pilot study
title_full_unstemmed Feasibility of evaluating AI-enabled digital symptom monitoring in metastatic patients with NSCLC receiving pembrolizumab therapy: A German single-arm observational pilot study
title_short Feasibility of evaluating AI-enabled digital symptom monitoring in metastatic patients with NSCLC receiving pembrolizumab therapy: A German single-arm observational pilot study
title_sort feasibility of evaluating ai enabled digital symptom monitoring in metastatic patients with nsclc receiving pembrolizumab therapy a german single arm observational pilot study
url https://doi.org/10.1177/20552076251348584
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