Trial Title:
Improvement of Quality of Life (QoL) Using Preference-Oriented QoLMonitoring in Patients With Lung Cancer
NCT ID:
NCT06252233
Condition:
Lung Cancer
Quality of Life
Conditions: Official terms:
Lung Neoplasms
Conditions: Keywords:
quality of life
lung cancer
definitive randomised controlled trial
patient empowerment
quality of life monitoring
patient and physician preferences
Study type:
Interventional
Study phase:
N/A
Overall status:
Recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Behavioral
Intervention name:
patient- and physician-centered QoL monitoring
Description:
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.
Arm group label:
Patient- and physician-centered QoL monitoring
Intervention type:
Other
Intervention name:
Placebo
Description:
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.
Arm group label:
Routine care
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.
Criteria for 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
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Klinikum Bamberg
Address:
City:
Bamberg
Zip:
96049
Country:
Germany
Status:
Recruiting
Contact:
Last name:
Rumo Leistner, MD, Dr.
Facility:
Name:
Hospital Bayreuth
Address:
City:
Bayreuth
Zip:
95445
Country:
Germany
Status:
Recruiting
Contact:
Last name:
Alexander Kiani, MD, Prof.
Facility:
Name:
Klinikum Coburg GmbH
Address:
City:
Coburg
Zip:
96450
Country:
Germany
Status:
Recruiting
Contact:
Last name:
Claus Steppert, MD, Dr.
Facility:
Name:
Klinikum Kulmbach
Address:
City:
Kulmbach
Zip:
95326
Country:
Germany
Status:
Recruiting
Contact:
Last name:
Thomas Bohrer, MD, Prof.
Facility:
Name:
Krankenhaus Barmherzige Brüder
Address:
City:
Regensburg
Zip:
93049
Country:
Germany
Status:
Recruiting
Contact:
Last name:
Hans-Stefan Hofmann, MD, Prof.
Contact backup:
Last name:
Michael Pfeifer, MD, Prof.
Facility:
Name:
Universitätsklinikum Regensburg
Address:
City:
Regensburg
Zip:
93053
Country:
Germany
Status:
Recruiting
Contact:
Last name:
Hans-Stefan Hofmann, MD, Prof.
Contact backup:
Last name:
Christian Schulz, MD, Prof.
Start date:
February 15, 2024
Completion date:
August 15, 2025
Lead sponsor:
Agency:
University of Bayreuth
Agency class:
Other
Collaborator:
Agency:
University of Regensburg, Tumor Center Regensburg, Center for Quality Management and Health Services Research
Agency class:
Other
Collaborator:
Agency:
G-BA Innovationsfonds
Agency class:
Other
Collaborator:
Agency:
University Hospital Regensburg, Center for Clinical Trials
Agency class:
Other
Collaborator:
Agency:
Bavarian Cancer Registry, Bavarian Health and Food Safety Authority
Agency class:
Other
Source:
University of Bayreuth
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06252233
