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SYMptom monitoring with Patient-Reported Outcomes using a web application among patients with Lung cancer in the Netherlands (SYMPRO-Lung): study protocol for a stepped-wedge randomised controlled trial

INTRODUCTION: Lung cancer and its treatment cause a wide range of symptoms impacting the patients’ health-related quality of life (HRQoL). The use of patient-reported outcomes (PRO) to monitor symptoms during and after cancer treatment has been shown not only to improve symptom management but also t...

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Autores principales: Billingy, Nicole E, Tromp, Vashti N M F, Veldhuijzen, Evalien, Belderbos, Jose, Aaronson, Neil K, Feldman, Esther, Hoek, Rianne J A, Bogaard, Harm-Jan, Onwuteaka-Philipsen, Bregje D, van de Poll-Franse, Lonneke, Hugtenburg, Jacqueline G, van den Hurk, Corina J G, Becker-Commissaris, Annemarie, Walraven, Iris
Formato: Online Artículo Texto
Lenguaje:English
Publicado: BMJ Publishing Group 2021
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8438957/
https://www.ncbi.nlm.nih.gov/pubmed/34518276
http://dx.doi.org/10.1136/bmjopen-2021-052494
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author Billingy, Nicole E
Tromp, Vashti N M F
Veldhuijzen, Evalien
Belderbos, Jose
Aaronson, Neil K
Feldman, Esther
Hoek, Rianne J A
Bogaard, Harm-Jan
Onwuteaka-Philipsen, Bregje D
van de Poll-Franse, Lonneke
Hugtenburg, Jacqueline G
van den Hurk, Corina J G
Becker-Commissaris, Annemarie
Walraven, Iris
author_facet Billingy, Nicole E
Tromp, Vashti N M F
Veldhuijzen, Evalien
Belderbos, Jose
Aaronson, Neil K
Feldman, Esther
Hoek, Rianne J A
Bogaard, Harm-Jan
Onwuteaka-Philipsen, Bregje D
van de Poll-Franse, Lonneke
Hugtenburg, Jacqueline G
van den Hurk, Corina J G
Becker-Commissaris, Annemarie
Walraven, Iris
author_sort Billingy, Nicole E
collection PubMed
description INTRODUCTION: Lung cancer and its treatment cause a wide range of symptoms impacting the patients’ health-related quality of life (HRQoL). The use of patient-reported outcomes (PRO) to monitor symptoms during and after cancer treatment has been shown not only to improve symptom management but also to improve HRQoL and overall survival (OS). Collectively, these results favour implementation of PRO-symptom monitoring in daily clinical care. However, these promising outcomes have been obtained under trial conditions in which patients were selected based on stringent inclusion criteria, and in countries with a dissimilar healthcare system than in the Netherlands. The primary aim of the SYMptom monitoring with Patient-Reported Outcomes using a web application among patients with Lung cancer in the Netherlands (SYMPRO-Lung) study is to evaluate the effect of PRO-symptom monitoring during and after lung cancer treatment on HRQoL in daily clinical practice. Secondary objectives include assessing the effect of PRO-symptom monitoring on progression-free survival, OS, the incidence and grade of PRO symptoms, medication adherence, implementation fidelity and cost-effectiveness. METHODS AND ANALYSIS: The SYMPRO-Lung study is a prospective, multicentre trial with a stepped wedge cluster randomised design. Study participants (n=292 intervention, n=292 controls) include patients with lung cancer (stages I–IV) starting treatment with surgery, systemic treatment, targeted treatment and/or radiotherapy. Every participating centre will consecutively switch from the control period to the intervention period, in which patients report their symptoms weekly via an online tool. In the intervention group, we evaluate two alert approaches: the active and reactive approach. If the symptoms exceed a predefined threshold, an alert is sent to the healthcare provider (active approach) or to the patient (reactive approach). Both the control and intervention group complete HRQoL questionnaires at 4 time points: at baseline, 15 weeks, 6 months and 1-year post treatment). Differences in HRQoL between the groups will be compared using linear mixed modelling analyses, accounting for within-centre clustering, potential time effects and confounding. ETHICS AND DISSEMINATION: The study protocol was approved by the Institutional Review Board and the Medical Ethics Committee of the Amsterdam UMC (under number NL 68440.029.18) and the institutional review boards of the participating study sites. The dissemination of the results will be conducted through publication in peer-reviewed journals and through scientific conferences. TRIAL REGISTRATION NUMBER: Trial register identifier: Netherlands Trial register Trial NL7897. Date of registration: 24 July 2019. https://www.trialregister.nl/trial/7897.
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spelling pubmed-84389572021-10-05 SYMptom monitoring with Patient-Reported Outcomes using a web application among patients with Lung cancer in the Netherlands (SYMPRO-Lung): study protocol for a stepped-wedge randomised controlled trial Billingy, Nicole E Tromp, Vashti N M F Veldhuijzen, Evalien Belderbos, Jose Aaronson, Neil K Feldman, Esther Hoek, Rianne J A Bogaard, Harm-Jan Onwuteaka-Philipsen, Bregje D van de Poll-Franse, Lonneke Hugtenburg, Jacqueline G van den Hurk, Corina J G Becker-Commissaris, Annemarie Walraven, Iris BMJ Open Oncology INTRODUCTION: Lung cancer and its treatment cause a wide range of symptoms impacting the patients’ health-related quality of life (HRQoL). The use of patient-reported outcomes (PRO) to monitor symptoms during and after cancer treatment has been shown not only to improve symptom management but also to improve HRQoL and overall survival (OS). Collectively, these results favour implementation of PRO-symptom monitoring in daily clinical care. However, these promising outcomes have been obtained under trial conditions in which patients were selected based on stringent inclusion criteria, and in countries with a dissimilar healthcare system than in the Netherlands. The primary aim of the SYMptom monitoring with Patient-Reported Outcomes using a web application among patients with Lung cancer in the Netherlands (SYMPRO-Lung) study is to evaluate the effect of PRO-symptom monitoring during and after lung cancer treatment on HRQoL in daily clinical practice. Secondary objectives include assessing the effect of PRO-symptom monitoring on progression-free survival, OS, the incidence and grade of PRO symptoms, medication adherence, implementation fidelity and cost-effectiveness. METHODS AND ANALYSIS: The SYMPRO-Lung study is a prospective, multicentre trial with a stepped wedge cluster randomised design. Study participants (n=292 intervention, n=292 controls) include patients with lung cancer (stages I–IV) starting treatment with surgery, systemic treatment, targeted treatment and/or radiotherapy. Every participating centre will consecutively switch from the control period to the intervention period, in which patients report their symptoms weekly via an online tool. In the intervention group, we evaluate two alert approaches: the active and reactive approach. If the symptoms exceed a predefined threshold, an alert is sent to the healthcare provider (active approach) or to the patient (reactive approach). Both the control and intervention group complete HRQoL questionnaires at 4 time points: at baseline, 15 weeks, 6 months and 1-year post treatment). Differences in HRQoL between the groups will be compared using linear mixed modelling analyses, accounting for within-centre clustering, potential time effects and confounding. ETHICS AND DISSEMINATION: The study protocol was approved by the Institutional Review Board and the Medical Ethics Committee of the Amsterdam UMC (under number NL 68440.029.18) and the institutional review boards of the participating study sites. The dissemination of the results will be conducted through publication in peer-reviewed journals and through scientific conferences. TRIAL REGISTRATION NUMBER: Trial register identifier: Netherlands Trial register Trial NL7897. Date of registration: 24 July 2019. https://www.trialregister.nl/trial/7897. BMJ Publishing Group 2021-09-12 /pmc/articles/PMC8438957/ /pubmed/34518276 http://dx.doi.org/10.1136/bmjopen-2021-052494 Text en © Author(s) (or their employer(s)) 2021. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ. https://creativecommons.org/licenses/by-nc/4.0/This is an open access article distributed in accordance with the Creative Commons Attribution Non Commercial (CC BY-NC 4.0) license, which permits others to distribute, remix, adapt, build upon this work non-commercially, and license their derivative works on different terms, provided the original work is properly cited, appropriate credit is given, any changes made indicated, and the use is non-commercial. See: http://creativecommons.org/licenses/by-nc/4.0/ (https://creativecommons.org/licenses/by-nc/4.0/) .
spellingShingle Oncology
Billingy, Nicole E
Tromp, Vashti N M F
Veldhuijzen, Evalien
Belderbos, Jose
Aaronson, Neil K
Feldman, Esther
Hoek, Rianne J A
Bogaard, Harm-Jan
Onwuteaka-Philipsen, Bregje D
van de Poll-Franse, Lonneke
Hugtenburg, Jacqueline G
van den Hurk, Corina J G
Becker-Commissaris, Annemarie
Walraven, Iris
SYMptom monitoring with Patient-Reported Outcomes using a web application among patients with Lung cancer in the Netherlands (SYMPRO-Lung): study protocol for a stepped-wedge randomised controlled trial
title SYMptom monitoring with Patient-Reported Outcomes using a web application among patients with Lung cancer in the Netherlands (SYMPRO-Lung): study protocol for a stepped-wedge randomised controlled trial
title_full SYMptom monitoring with Patient-Reported Outcomes using a web application among patients with Lung cancer in the Netherlands (SYMPRO-Lung): study protocol for a stepped-wedge randomised controlled trial
title_fullStr SYMptom monitoring with Patient-Reported Outcomes using a web application among patients with Lung cancer in the Netherlands (SYMPRO-Lung): study protocol for a stepped-wedge randomised controlled trial
title_full_unstemmed SYMptom monitoring with Patient-Reported Outcomes using a web application among patients with Lung cancer in the Netherlands (SYMPRO-Lung): study protocol for a stepped-wedge randomised controlled trial
title_short SYMptom monitoring with Patient-Reported Outcomes using a web application among patients with Lung cancer in the Netherlands (SYMPRO-Lung): study protocol for a stepped-wedge randomised controlled trial
title_sort symptom monitoring with patient-reported outcomes using a web application among patients with lung cancer in the netherlands (sympro-lung): study protocol for a stepped-wedge randomised controlled trial
topic Oncology
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8438957/
https://www.ncbi.nlm.nih.gov/pubmed/34518276
http://dx.doi.org/10.1136/bmjopen-2021-052494
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