Clinical trial NCT06252233: Improvement of Quality of Life (QoL) Using Preference-Oriented QoLMonitoring in Patients with Lung Cancer
Official title: Improvement of Quality of Life (QoL) Using Preference-Oriented QoLMonitoring and Linkage with Clinical Registry Data: Randomised Clinical Trial in Patients with Lung Cancer
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
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
Lead sponsor: University of Bayreuth
Sponsor class: OTHER
Collaborators: name: University of Regensburg, Tumor Center Regensburg, Center for Quality Management and Health Services Research
name: G-BA Innovationsfonds
name: University Hospital Regensburg, Center for Clinical Trials
name: Bavarian Cancer Registry, Bavarian Health and Food Safety Authority
First posted: 2024-02-09
Enrollment: 220
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Proportion of patients with a need for QoL therapy in at least one dimension of the QoL profile at 6 months
timeFrame: 6 months after study entry
Secondary outcomes:
measure: 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
timeFrame: 1, 2, 3, 4, 5, 6 months after study entry
Other outcomes:
Locations:
city: Bamberg
country: Germany
facility: Klinikum Bamberg
city: Bayreuth
country: Germany
facility: Hospital Bayreuth
city: Coburg
country: Germany
facility: Klinikum Coburg GmbH
city: Donaustauf
country: Germany
facility: Caritas Krankenhaus St. Maria Donaustauf
city: Kulmbach
country: Germany
facility: Klinikum Kulmbach
city: Regensburg
country: Germany
facility: Krankenhaus Barmherzige Brüder
city: Regensburg
country: Germany
facility: Universitätsklinikum Regensburg
city: Straubing
country: Germany
facility: Klinikum St. Elisabeth Straubing
Study officials:
affiliation: University of Bayreuth, Faculty of Law, Business and Economics, Institute for Healthcare Management and Health Sciences
name: Martin Emmert, PhD, Prof.
role: STUDY_CHAIR
affiliation: University of Regensburg, Centre for Quality Management and Health Services Resarch
name: Monika Klinkhammer-Schalke, MD, Prof.
role: STUDY_CHAIR
References:
citation: 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.
citation: 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.
citation: 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.