Improvement of Quality of Life (QoL) Using Preference-Oriented QoLMonitoring in Patients with Lung Cancer

NCT06252233 | Recruiting DMC

• 1 other identifier: LePaLuMo_2023
• Study Type: interventional
• Target: 220
• Locations: 1 country
• Sites: 8

Brief Summary

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

Lung Cancer; Quality of Life

Keywords

quality of life; lung cancer; definitive randomised controlled trial; patient empowerment; quality of life monitoring; patient and physician preferences

Outcome Measures

Primary Outcomes (1)

• Proportion of patients with a need for QoL therapy in at least one dimension of the QoL profile at 6 months

  proportion of patients in both groups with a need for QoL therapy (\<50 points) in at least one of eight dimensions of the QoL profile: global quality of life, shortness of breath, physical functioning, social functioning, fear of progression, emotional functioning, pain, financial impact

  6 months after study entry

Secondary Outcomes (1)

• Proportion of patients with a need for QoL therapy in each dimension of the QoL profile at 1, 2, 3, 4, 5, and 6 months

  1, 2, 3, 4, 5, 6 months after study entry

Study Arms (2)

Patient- and physician-centered QoL monitoring

EXPERIMENTAL

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.

Behavioral: patient- and physician-centered QoL monitoring

Routine care

PLACEBO COMPARATOR

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.

Other: Placebo

Interventions

patient- and physician-centered QoL monitoring BEHAVIORAL

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.

Patient- and physician-centered QoL monitoring

Placebo OTHER

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.

Routine care

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• primary diagnosis of lung cancer (ICD C33/C34, all stages)
• 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);
• difference between date of histology and date of study entry not exceeding 2 months;
• informed consent;

You may not qualify if:

• unavailability of a study clinician for patient recruitment;
• patient misclassified in the candidate list (no primary diagnosis, no lung tumour);
• coordinating practitioner refuses trial participation;
• patient outside the defined study region (Germany, Bavaria: Upper Palatinate, Lower Bavaria, Upper Franconia);
• age under 18 years;
• pregnancy/ breastfeeding;
• patient unable to fill out the QoL questionnaire (physical, psychological, cognitive, language reasons);
• patient refuses trial participation

Sponsors & Collaborators

• University of Bayreuth: lead
• University of Regensburg, Tumor Center Regensburg, Center for Quality Management and Health Services Research: collaborator
• G-BA Innovationsfonds: collaborator
• University Hospital Regensburg, Center for Clinical Trials: collaborator
• Bavarian Cancer Registry, Bavarian Health and Food Safety Authority: collaborator

Study Sites (8)

Klinikum Bamberg

Bamberg, 96049, Germany

RECRUITING

Hospital Bayreuth

Bayreuth, 95445, Germany

RECRUITING

Klinikum Coburg GmbH

Coburg, 96450, Germany

RECRUITING

Caritas Krankenhaus St. Maria Donaustauf

Donaustauf, 93093, Germany

RECRUITING

Klinikum Kulmbach

Kulmbach, 95326, Germany

RECRUITING

Krankenhaus Barmherzige Brüder

Regensburg, 93049, Germany

RECRUITING

Universitätsklinikum Regensburg

Regensburg, 93053, Germany

RECRUITING

Klinikum St. Elisabeth Straubing

Straubing, 94315, Germany

RECRUITING

Related Publications (4)

• 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.

  PMID: 32179445 BACKGROUND

• 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.

  PMID: 22315052 BACKGROUND

• 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.

  PMID: 34176020 BACKGROUND

• 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.

  PMID: 40958112 DERIVED

MeSH Terms

Conditions

Lung Neoplasms; Patient Participation

Condition Hierarchy (Ancestors)

Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases; Patient Acceptance of Health Care; Treatment Adherence and Compliance; Health Behavior; Behavior

Study Officials

• Martin Emmert, PhD, Prof.

  University of Bayreuth, Faculty of Law, Business and Economics, Institute for Healthcare Management and Health Sciences

  STUDY CHAIR

• Monika Klinkhammer-Schalke, MD, Prof.

  University of Regensburg, Centre for Quality Management and Health Services Resarch

  STUDY CHAIR

Central Study Contacts

Martin Emmert, PhD, Prof.

CONTACT

+49 160 92203562; martin.emmert@uni-bayreuth.de

Monika Klinkhammer-Schalke, MD, Prof.

CONTACT

+49-941-943-1803; monika.klinkhammer-schalke@ur.de

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof. Dr. Martin Emmert

Study Record Dates

• First Submitted: February 1, 2024
• First Posted: February 9, 2024
• Study Start: February 15, 2024
• Primary Completion: February 15, 2025
• Study Completion: August 15, 2025
• Last Updated: December 16, 2024

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: 6 months after date of publication until 60 months after date of publication
• Access Criteria: Data will be made available to other scientists upon request for nonprofit research. The contact address is monika.klinkhammer-schalke@ur.de. Scientists are required to send their predefined statistical analysis plan. Together with the scientific review board of the Tumor Center Regensburg a decision will be made based on the quality and usefulness of planned statistical analysis. In case of a positive decision the scientist is required to sign a contract for data usage before receiving anonymized IPD.

Locations

DE (8)