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

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

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.

Study Overview

• Status: Recruiting
• Conditions: Quality of Life; Lung Cancer
• Intervention / Treatment: Behavioral: patient- and physician-centered QoL monitoring; Other: Placebo

Detailed Description

A pathway with quality of life (QoL) diagnosis and therapeutic options for patients with breast cancer and colorectal cancer has been successfully designed, implemented, and evaluated as guided by the Medical Research Council framework for developing and testing complex interventions. In two randomised controlled trials the investigators could demonstrate that patients with breast cancer and colorectal cancer had a benefit from the diagnosis of QoL deficits and tailored therapeutic options in their treatment in terms of a decrease in QoL deficits.

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.

• Study Type: Interventional
• Enrollment (Estimated): 220
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Martin Emmert, PhD, Prof.; Phone Number: +49 160 92203562; Email: martin.emmert@uni-bayreuth.de
• Study Contact Backup: Name: Monika Klinkhammer-Schalke, MD, Prof.; Phone Number: +49-941-943-1803; Email: monika.klinkhammer-schalke@ur.de

Study Locations

• Germany
  • Bamberg, Germany, 96049
    • Recruiting
    • Klinikum Bamberg
    • Contact: Rumo Leistner, MD, Dr.
  • Bayreuth, Germany, 95445
    • Recruiting
    • Hospital Bayreuth
    • Contact: Alexander Kiani, MD, Prof.
  • Coburg, Germany, 96450
    • Recruiting
    • Klinikum Coburg GmbH
    • Contact: Claus Steppert, MD, Dr.
  • Kulmbach, Germany, 95326
    • Recruiting
    • Klinikum Kulmbach
    • Contact: Thomas Bohrer, MD, Prof.
  • Regensburg, Germany, 93053
    • Recruiting
    • Universitätsklinikum Regensburg
    • Contact: Hans-Stefan Hofmann, MD, Prof.
    • Contact: Christian Schulz, MD, Prof.
  • Regensburg, Germany, 93049
    • Recruiting
    • Krankenhaus Barmherzige Brüder
    • Contact: Hans-Stefan Hofmann, MD, Prof.
    • Contact: Michael Pfeifer, MD, Prof.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Behavioral: 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 Comparator: 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.	Other: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	proportions of patients with a need for QoL therapy (<50 points) in each single dimension of the QoL profile: global quality of life, shortness of breath, physical functioning, social functioning, fear of progression, emotional functioning, pain, financial impact	1, 2, 3, 4, 5, 6 months after study entry

Collaborators and Investigators

• Sponsor: University of Bayreuth
• Collaborators: University of Regensburg, Tumor Center Regensburg, Center for Quality Management and Health Services Research; G-BA Innovationsfonds; University Hospital Regensburg, Center for Clinical Trials; Bavarian Cancer Registry, Bavarian Health and Food Safety Authority
• Investigators: Study Chair: 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

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): February 15, 2024
• Primary Completion (Estimated): February 15, 2025
• Study Completion (Estimated): August 15, 2025

Study Registration Dates

• First Submitted: February 1, 2024
• First Submitted That Met QC Criteria: February 1, 2024
• First Posted (Actual): February 9, 2024

Study Record Updates

• Last Update Posted (Actual): April 22, 2024
• Last Update Submitted That Met QC Criteria: April 18, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Keywords: quality of life; lung cancer; patient empowerment; quality of life monitoring; patient and physician preferences; definitive randomised controlled trial
• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Neoplasms; Lung Diseases; Neoplasms by Site; Respiratory Tract Neoplasms; Thoracic Neoplasms; Lung Neoplasms
• Other Study ID Numbers: LePaLuMo_2023

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Anonymized individual participant data (IPD) that underlie the results in a publication are planned to be made available upon request of scientists.
• IPD Sharing Time Frame: 6 months after date of publication until 60 months after date of publication
• IPD Sharing 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.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No