Evidence map›Paper›PMID 40958112›Full record

ArticleTrials2025

Preference-oriented quality of life monitoring and linkage with clinical registry data: study protocol of a randomised clinical trial in patients with lung cancer (LePaLuMo Study).

Patricia Lindberg-Scharf, Martin Emmert, Michael Koller, Florian Gürtler, Brunhilde Steinger, Jacqueline Müller-Nordhorn, Florian Zeman, Sophie Friebel, Ksenia Ibler, Jan Kurz and 3 more

Registry-linked trialAbstract readClinical Trial Protocol
PubMed Full text at PMC Publisher
In one paragraph

Article in Trials, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT06252233 (Improvement of Quality of Life), which is not on this map. Cited by 1 paper, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
1citing papers in PubMed, 1 pooled it
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT06252233 narecruitingnot on this map

Improvement of Quality of Life (QoL) Using Preference-Oriented QoLMonitoring and Linkage with Clinical Registry Data: Randomised Clinical Trial in Patients with Lung Cancer

TypeinterventionalSponsorUniversity of BayreuthRan2024 to 2025Enrolled220ConditionsLung Cancer, Quality of LifeArmspatient- and physician-centered QoL monitoring, Placebo
3 · Its place in the literature

Who cites it

1 citing paper in PubMed, 1 synthesis or guideline pooled it.

  1. Pooled it
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

13 authors.

Patricia Lindberg-ScharfTumor Center Regensburg, Center of Quality Management and Health Services Research, University of Regensburg, Am BioPark 9, 93053, Regensburg, Germany.
Martin EmmertInstitute for Healthcare Management and Health Sciences, Faculty of Law, Business and Economics, University of Bayreuth, Universitätsstraße 30, 95447, Bayreuth, Germany.
Michael KollerCenter for Clinical Studies, University Hospital Regensburg, Franz-Josef-Strauß-Allee 11, 93053, Regensburg, Germany.
Florian GürtlerTumor Center Regensburg, Center of Quality Management and Health Services Research, University of Regensburg, Am BioPark 9, 93053, Regensburg, Germany.
Brunhilde SteingerTumor Center Regensburg, Center of Quality Management and Health Services Research, University of Regensburg, Am BioPark 9, 93053, Regensburg, Germany.
Jacqueline Müller-NordhornBavarian Cancer Registry, Bavarian Health and Food Safety Authority, Schweinauer Hauptstraße 80, 90441, Nuremberg, Germany.
Florian ZemanCenter for Clinical Studies, University Hospital Regensburg, Franz-Josef-Strauß-Allee 11, 93053, Regensburg, Germany.
Sophie FriebelInstitute for Healthcare Management and Health Sciences, Faculty of Law, Business and Economics, University of Bayreuth, Universitätsstraße 30, 95447, Bayreuth, Germany.
Ksenia IblerInstitute for Healthcare Management and Health Sciences, Faculty of Law, Business and Economics, University of Bayreuth, Universitätsstraße 30, 95447, Bayreuth, Germany.
Jan KurzTumor Center Regensburg, Center of Quality Management and Health Services Research, University of Regensburg, Am BioPark 9, 93053, Regensburg, Germany.
Thomas StanglTumor Center Regensburg, Center of Quality Management and Health Services Research, University of Regensburg, Am BioPark 9, 93053, Regensburg, Germany.
Monika Klinkhammer-SchalkeTumor Center Regensburg, Center of Quality Management and Health Services Research, University of Regensburg, Am BioPark 9, 93053, Regensburg, Germany.
Vinzenz VölkelTumor Center Regensburg, Center of Quality Management and Health Services Research, University of Regensburg, Am BioPark 9, 93053, Regensburg, Germany. Vinzenz.Voelkel@klinik.uni-regensburg.de.ORCID http://orcid.org/0000-0002-2057-4904

Funding

Gemeinsame Bundesausschuss 01VSF22035
6 · The paper itself

Abstract

backgroundIn routine oncological care, the implementation of disease-related quality of life (QoL) is still an open matter. In a complex intervention, a QoL monitoring system including tailored therapeutic options has been designed, implemented, and its effectiveness has been demonstrated in two randomised trials in patients with breast and colorectal cancer. The next step is to extend the usability of the QoL monitoring system for patients with other cancer diagnoses and in other regions. Necessary adaptations include an electronic measurement of QoL and consideration of patient and physician preferences. The present randomised trial investigates the effectiveness of this adapted QoL monitoring system in patients with lung cancer in two regions in Bavaria, Germany.

methodsIn this 2-arm randomised, prospective, pragmatic, multicentre clinical trial with one intervention and one control group, QoL of primary lung cancer patients is assessed with an electronic patient- and physician-oriented QoL monitoring system using the EORTC QLQ-C30 and QLQ-LC29 questionnaires at study entry and at 1, 2, 3, 4, 5, and 6 months during follow-up care. The QoL data of each patient are linked with clinical data from the Bavarian Cancer Registry for the purpose of data analysis. In the intervention group, the results of QoL monitoring are automatically transferred to a QoL profile including 8 dimensions on scales of 0-100 (cut-off "need for QoL therapy" < 50 points). QoL results are obtained in real-time by patients and their treating physicians. To treat QoL deficits, a multi-professional network of healthcare providers is established. In the control group, QoL is also measured, but neither patients nor treating physicians have access to the results. The investigators expect that the proportion of patients in both groups with a need for QoL therapy (< 50 points in at least one dimension of the QoL profile) will be lower in the intervention group than in the control group at the primary endpoint 6 months after study entry. DISCUSSION: This is the first study investigating the effectiveness of a QoL monitoring system based on patient- and physician-oriented preferences with a high degree of generalisability by including inpatient and outpatient care as well as different study regions.

trial registrationClinicalTrials.gov NCT06252233. Registered on February 2024.

Indexed as

Lung NeoplasmsPatient PreferenceQuality of LifeFemaleGermanyHumansMulticenter Studies as TopicPragmatic Clinical Trials as TopicProspective StudiesRandomized Controlled Trials as TopicRegistriesSurveys and QuestionnairesTime FactorsDefinitive RCTLung cancerPatient and physician preferencesPatient empowermentQuality of lifeQuality of life monitoring

Identifiers

PMID40958112
PMCPMC12439385

What OpenQuestion holds

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Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.