Short summary

The study is a prospective registry analysis, where PROMs and information from Danish Lung Cancer Registry (DLCR) are integrated. All patients registered with a lung cancer diagnosis in DLCR in the period 01.01.14-31.12.15 are included, and receive questionnaires 4 times during their clinical course: First time at diagnosis, and then 3, 6 and 12 months after initial treatment. The validated cancer generic questionnaire "Quality of Life Questionnaire Cancer 30" (EORTC_QLQ-QC30)(Aaronson et al., 1993) and the validated lung cancer specific questionnaire "Quality of Life Questionnaire Lung Cancer 13" (EORTC_QLQ_LC13) are applied.

Rationale

Backgroud:

The evaluation of quality of lung cancer treatment is limited by the fact that measurements concerning patients' quality of life and symptoms after treatment are not monitored. Information about patients' self-reported symptoms, functional capacity and quality of life - lso known as patient reported outcome measurements (PROMs) - has the potential to improve quality and outcomes of treatment effort. A systematic test of this in lung cancer patients can make a foundation of experience for the whole cancer field.

Purpose:

The purposes of the project are:

• To explore PROMs' applications for quality registration, comprising data quality, data validity and data completeness.
• To explore the correlation between lung cancer disease's manifestations, the treatment given, the patient's socioeconomic conditions and PROMs in the clinical course.

PROMs made several times during a clinical course make continuing long-term studies possible, and will tell us about the prognosis of the lung cancer patients.

Over time, PROM-data will have the potential to make evidence for results and consequences of treatment efficacy for lung cancer patients in terms of audit and quality assurance, and will furthermore make it possible to apply comparison and evaluation between different treatment regimes.

Perspective:

In its entirety, the integration of PROMs will enable contribution to secure, that Danish cancer patients' evaluation of treatment, course of the treatment and its effects on their health and health related quality of life, as well as their evaluation of the quality of the clinical course, will be variables in the clinical quality database in terms of benchmarking, quality monitoring, support of the patients' clinical courses before and especially after treatment. Furthermore, collection of PROMs will create more knowledge about sequelae after treatment for lung cancer.

Description of the cohort

All patients registered with a lung cancer diagnosis in DLCR in the period 01.01.14-31.12.15 are included in the study.

Data and biological material

The data of the study are partly PROM-data from the questionnaires, partly register-data from DLCR.

Data from PROMs is, as mentioned earlier, derived from questionnaires for incident cases of lung cancer in the period of time from 1st of January 2014 until 31st of December 2015.

The validated cancer generic questionnaire "Quality of Life Questionnaire Cancer 30" (EORTC_QLQ-QC30)(Aaronson et al., 1993) and the validated lung cancer specific questionnaire "Quality of Life Questionnaire Lung Cancer 13" (EORTC_QLQ_LC13) are applied.

Furthermore, the complete set of data accessible in DLCR will be applied, that is information about:

• Clinical condition before treatment, including:
• Diagnosis
• Age + sex
• Performance status
• Lung function
• Tobacco consumption
• Comorbidity score (Charlson)
• Examination procedures
• Clinical TNM stadium
• Pathology
• Surgical treatment, including:
• Date of treatment
• Achohol comsumption
• Surgical information
• Complications
• Pathological TNM stadium
• Oncological treatment, including:
• Date of treatment
• Performance
• TNM stadium
• Treatment information

Information about socioeconomic conditions is retrieved from Denmark's Statistics, including familial- and professional status and medical consumption in the period of inclusion.

Collaborating researchers and departments

Department of Thoracic, Cardiac and Vascular Surgery, Odense University Hospital

• PhD-student Majken Munk Brønserud, MD
• Clinical Associate Professor Erik Jakobsen, MD, PhD

OPEN Odense Patient data Explorative Network, Odense University Hospital

• Professor and Consultant Anders Green, MD, PhD

Institute of Science in Public Health, University of Copenhagen

• Professor Mogens Grønvold, PhD

Department of Clinical Epidemiology, Odense University Hospital

• Statistician Maria Iachina, PhD