Ignite Creation Date:
2025-12-25 @ 2:46 AM
Ignite Modification Date:
2025-12-26 @ 1:27 AM
Study NCT ID:
NCT06252233
Status:
RECRUITING
Last Update Posted:
2024-12-16
First Post:
2024-02-01
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Improvement of Quality of Life (QoL) Using Preference-Oriented QoLMonitoring in Patients with Lung Cancer
Sponsor:
University of Bayreuth
Organization:
Study Overview
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
Status:
RECRUITING
Status Verified Date:
2024-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
LePaLuMo
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.
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 Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?: