Improvement of Quality of Life (QoL) Using Preference-Oriented QoLMonitoring in Patients with Lung Cancer
NCT ID: NCT06252233
Last Updated: 2024-12-16
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
220 participants
INTERVENTIONAL
2024-02-15
2025-08-15
Brief Summary
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Detailed Description
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The next step is to extend usability of the QoL system so that it can be as well used by patients with other cancer diagnoses and in other study regions. Therefore, QoL will be assessed using an electronic patient- and physician-centered QoL monitoring system which is based on previous work of the research group. The QoL monitoring system is adapted based on results of a preliminary study using discrete choice experiments (DCE) identifying preferences of lung cancer patients and their physicians regarding the importance of individual QoL dimensions.
In this two-arm randomised, controlled, prospective, pragmatic, multicentre clinical trial with one intervention group and one control group QoL of primary lung cancer patients will be assessed with an electronic patient- and physician-centered QoL monitoring system using the quality of life questionnaires (QLQ) of the European Organisation for Research and Treatment of Cancer EORTC QLQ-C30 (core module) and QLQ-LC29 (lung cancer module) at study entry and at 1, 2, 3, 4, 5, and 6 months during follow-up care. Data of each patient's QoL will be linked with clinical data from the Bavarian Cancer Registry for the purpose of data analysis.
In the intervention group results of QoL monitoring are automatically transferred to a preference-based QoL profile including 8 dimensions on scales of 0-100 (cutoff of a "need for QoL therapy" \<50). Patients and their treating physicians receive the results of their QoL monitoring in real-time. In order to be able to treat QoL deficits a multi-professional network of therapists is established (e.g. pain therapy, psychotherapy, social support, nutrition counselling, physiotherapy, fitness, respiratory therapy, palliative care). In the intervention group patients and their physicians receive complete lists of QoL healthcare professionals of this network practicing in their region.
In the control group QoL is also measured but neither patients nor treating physicians have access to the results of QoL monitoring, but the therapist network is also available for this study arm.
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 intervention group patients compared with control group patients at the primary endpoint 6 months after study entry.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Patient- and physician-centered QoL monitoring
Quality of life (QoL) of patients is assessed with an electronic patient- and physician-centered QoL monitoring system using the questionnaires EORTC QLQ-C30 and QLQ-LC29 at study entry and at 1, 2, 3, 4, 5, and 6 months during follow-up care. Results of QoL monitoring are automatically transferred to a QoL profile. Patients and their treating physicians receive the results of their QoL monitoring in real-time. In order to be able to treat QoL deficits a multiprofessional network of therapists is established (e.g. pain therapy, psychotherapy, social support, nutrition counselling, physiotherapy, fitness, respiratory therapy). Intervention group physicians and patients receive complete lists of QoL healthcare professionals of this network practicing in their region. To provide continuous medical education, quality circles for therapy options have been founded.
patient- and physician-centered QoL monitoring
Electronic QoL monitoring including QoL diagnosis and therapy (pain therapy, psychotherapy, social support, nutrition, physiotherapy, fitness, respiratory counselling, palliative care). Patients and treating physicians have access to the results of their QoL monitoring and to a network of local healthcare providers.
Routine care
QoL of patients is also assessed with the same QoL monitoring system used in the intervention group at study entry and at 1, 2, 3, 4, 5, and 6 months but neither patients nor treating physicians have access to the QoL profiles. The therapist network is also available for control arm.
Placebo
Electronic QoL monitoring without QoL diagnosis and therapy. Patients and treating physicians have no access to the results of their QoL monitoring. The therapist network is also available for control arm.
Interventions
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patient- and physician-centered QoL monitoring
Electronic QoL monitoring including QoL diagnosis and therapy (pain therapy, psychotherapy, social support, nutrition, physiotherapy, fitness, respiratory counselling, palliative care). Patients and treating physicians have access to the results of their QoL monitoring and to a network of local healthcare providers.
Placebo
Electronic QoL monitoring without QoL diagnosis and therapy. Patients and treating physicians have no access to the results of their QoL monitoring. The therapist network is also available for control arm.
Eligibility Criteria
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Inclusion Criteria
2. treatment in one of six recruiting hospitals treating patients with lung cancer (University Hospital Regensburg, Hospital Barmherzige Brüder Regensburg, Hospital Bayreuth, Hospital Coburg, Hospital Kulmbach, Hospital Bamberg);
3. difference between date of histology and date of study entry not exceeding 2 months;
4. informed consent;
Exclusion Criteria
2. patient misclassified in the candidate list (no primary diagnosis, no lung tumour);
3. coordinating practitioner refuses trial participation;
4. patient outside the defined study region (Germany, Bavaria: Upper Palatinate, Lower Bavaria, Upper Franconia);
5. age under 18 years;
6. pregnancy/ breastfeeding;
7. patient unable to fill out the QoL questionnaire (physical, psychological, cognitive, language reasons);
8. patient refuses trial participation
18 Years
ALL
No
Sponsors
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University of Regensburg, Tumor Center Regensburg, Center for Quality Management and Health Services Research
UNKNOWN
G-BA Innovationsfonds
UNKNOWN
University Hospital Regensburg, Center for Clinical Trials
UNKNOWN
Bavarian Cancer Registry, Bavarian Health and Food Safety Authority
UNKNOWN
University of Bayreuth
OTHER
Responsible Party
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Martin Emmert
Prof. Dr. Martin Emmert
Principal Investigators
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Martin Emmert, PhD, Prof.
Role: STUDY_CHAIR
University of Bayreuth, Faculty of Law, Business and Economics, Institute for Healthcare Management and Health Sciences
Monika Klinkhammer-Schalke, MD, Prof.
Role: STUDY_CHAIR
University of Regensburg, Centre for Quality Management and Health Services Resarch
Locations
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Klinikum Bamberg
Bamberg, , Germany
Hospital Bayreuth
Bayreuth, , Germany
Klinikum Coburg GmbH
Coburg, , Germany
Caritas Krankenhaus St. Maria Donaustauf
Donaustauf, , Germany
Klinikum Kulmbach
Kulmbach, , Germany
Krankenhaus Barmherzige Brüder
Regensburg, , Germany
Universitätsklinikum Regensburg
Regensburg, , Germany
Klinikum St. Elisabeth Straubing
Straubing, , Germany
Countries
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Central Contacts
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Facility Contacts
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Rumo Leistner, MD, Dr.
Role: primary
Alexander Kiani, MD, Prof.
Role: primary
Claus Steppert, MD, Dr.
Role: primary
Maximilian Malfertheiner, MD, Prof.
Role: primary
Thomas Bohrer, MD, Prof.
Role: primary
Joseph Alhanna, MD, Dr.
Role: backup
Hans-Stefan Hofmann, MD, Prof.
Role: primary
Michael Pfeifer, MD, Prof.
Role: backup
Hans-Stefan Hofmann, MD, Prof.
Role: primary
Christian Schulz, MD, Prof.
Role: backup
Jorge Fernando Gamarra, MD, Dr.
Role: primary
Jochen Grassinger, MD, Prof.
Role: backup
References
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Klinkhammer-Schalke M, Steinger B, Koller M, Zeman F, Furst A, Gumpp J, Obermaier R, Piso P, Lindberg-Scharf P; Regensburg QoL Study Group. Diagnosing deficits in quality of life and providing tailored therapeutic options: Results of a randomised trial in 220 patients with colorectal cancer. Eur J Cancer. 2020 May;130:102-113. doi: 10.1016/j.ejca.2020.01.025. Epub 2020 Mar 13.
Klinkhammer-Schalke M, Koller M, Steinger B, Ehret C, Ernst B, Wyatt JC, Hofstadter F, Lorenz W; Regensburg QoL Study Group. Direct improvement of quality of life using a tailored quality of life diagnosis and therapy pathway: randomised trial in 200 women with breast cancer. Br J Cancer. 2012 Feb 28;106(5):826-38. doi: 10.1038/bjc.2012.4. Epub 2012 Feb 7.
Lindberg-Scharf P, Steinger B, Koller M, Hofstadter A, Ortmann O, Kurz J, Sasse J, Klinkhammer-Schalke M. Long-term improvement of quality of life in patients with breast cancer: supporting patient-physician communication by an electronic tool for inpatient and outpatient care. Support Care Cancer. 2021 Dec;29(12):7865-7875. doi: 10.1007/s00520-021-06270-1. Epub 2021 Jun 27.
Lindberg-Scharf P, Emmert M, Koller M, Gurtler F, Steinger B, Muller-Nordhorn J, Zeman F, Friebel S, Ibler K, Kurz J, Stangl T, Klinkhammer-Schalke M, Volkel V. 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). Trials. 2025 Sep 16;26(1):339. doi: 10.1186/s13063-025-09102-3.
Other Identifiers
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LePaLuMo_2023
Identifier Type: -
Identifier Source: org_study_id
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