Lung Cancer, Quality of Life
Conditions
Keywords
quality of life, lung cancer, definitive randomised controlled trial, patient empowerment, quality of life monitoring, patient and physician preferences
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.
Interventions
BEHAVIORALpatient- 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.
OTHERPlacebo
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.
Sponsors
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
University of Bayreuth
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Proportion of patients with a need for QoL therapy in at least one dimension of the QoL profile at 6 months | 6 months after study entry | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 | 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 |
Countries
Germany
Contacts
Primary ContactMartin Emmert, PhD, Prof.
Backup ContactMonika Klinkhammer-Schalke, MD, Prof.
Outcome results
None listed