Clinical trial · Interventional
Improvement of Quality of Life (QoL) Using Preference-Oriented QoLMonitoring in Patients with Lung Cancer
Improvement of Quality of Life (QoL) Using Preference-Oriented QoLMonitoring and Linkage with Clinical Registry Data: Randomised Clinical Trial in Patients with Lung Cancer
NCT06252233CI-TRIAL-00083802LePaLuMorecruitingN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
The purpose of the study is to determine whether a preference-oriented quality of life monitoring with defined diagnostic and therapeutic options improves quality of life in patients with lung cancer during routine follow-up care.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Lung Cancer | Malignant Lung Neoplasm | CURATED_EXACT | 0.92 |
| Quality of Life | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| patient- and physician-centered QoL monitoring | Behavioral | — | UNRESOLVED |
| Placebo | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Patient- and physician-centered QoL monitoring
- description
- 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.
- interventionNames
- Behavioral: patient- and physician-centered QoL monitoring
- type
- PLACEBO_COMPARATOR
- label
- Routine care
- description
- 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.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: 1. primary diagnosis of lung cancer (ICD C33/C34, all stages) 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: 1. unavailability of a study clinician for patient recruitment; 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
References
Publications (4)
- BACKGROUNDKlinkhammer-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. PMID 32179445
- BACKGROUNDKlinkhammer-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. PMID 22315052
- BACKGROUNDLindberg-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. PMID 34176020
- DERIVEDLindberg-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. PMID 40958112