Preference-oriented quality of life monitoring and linkage with clinical registry data: study protocol of a randomised clinical trial in patients with lung cancer (LePaLuMo Study)

Abstract

Background: In routine oncological care, the implementation of disease-related quality of life (QoL) is still an open matter. In a complex intervention, a QoL monitoring system including tailored therapeutic options has been designed, implemented, and its effectiveness has been demonstrated in two randomised trials in patients with breast and colorectal cancer. The next step is to extend the usability of the QoL monitoring system for patients with other cancer diagnoses and in other regions. Necessary adaptations include an electronic measurement of QoL and consideration of patient and physician preferences. The present randomised trial investigates the effectiveness of this adapted QoL monitoring system in patients with lung cancer in two regions in Bavaria, Germany.

Methods: In this 2-arm randomised, prospective, pragmatic, multicentre clinical trial with one intervention and one control group, QoL of primary lung cancer patients is assessed with an electronic patient- and physician-oriented QoL monitoring system using the EORTC QLQ-C30 and QLQ-LC29 questionnaires at study entry and at 1, 2, 3, 4, 5, and 6 months during follow-up care. The QoL data of each patient are linked with clinical data from the Bavarian Cancer Registry for the purpose of data analysis. In the intervention group, the results of QoL monitoring are automatically transferred to a QoL profile including 8 dimensions on scales of 0-100 (cut-off "need for QoL therapy" < 50 points). QoL results are obtained in real-time by patients and their treating physicians. To treat QoL deficits, a multi-professional network of healthcare providers is established. In the control group, QoL is also measured, but neither patients nor treating physicians have access to the results. 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 the intervention group than in the control group at the primary endpoint 6 months after study entry.

Discussion: This is the first study investigating the effectiveness of a QoL monitoring system based on patient- and physician-oriented preferences with a high degree of generalisability by including inpatient and outpatient care as well as different study regions.

Trial registration: ClinicalTrials.gov NCT06252233. Registered on February 2024.

Keywords: Definitive RCT; Lung cancer; Patient and physician preferences; Patient empowerment; Quality of life; Quality of life monitoring.

Fig. 1

Selection of patients

Fig. 2

Schedule (SPIRIT diagram) of enrolment, interventions, and assessments

Fig. 3

Patients in the intervention group (quality of life (QoL) pathway) following recruitment for the randomised trial. This pathway is considered for routine clinical practice

Fig. 4

QoL profile of patients with lung cancer in the intervention group. The cutoff for a need for QoL therapy is < 50 points

Fig. 5

Data flow