Distress and Quality of Life During the Diagnostic Phase of a Suspected Serious Lung Disease

Completed

• Conditions: Suspected Lung Cancer

• Registration Number: NCT02060877
• Lead Sponsor: Universiteit Antwerpen

Brief Summary

The purpose of this study is to gain insight in the distress experience and quality of life of patients suspected of having a serious lung disease during the diagnostic phase and the period between diagnosis and start of treatment

Detailed Description

A life-threatening disease often leads to distress, an emotional experience that can interfere with coping. Studies in lung cancer patients show high prevalence of distress during the course of the disease. However until now, very few research was done during the diagnostic workup. This prospective study will describe and explore distress, quality of life and illness perception in lung cancer patients during the diagnostic period until first follow-up visit 4 weeks after start of therapy. Patient reported questionnaires will be used.

Study Timeline

• Study Start: 2014-02
• Study First Submitted: 2014-02-04
• Study First Submitted QC: 2014-02-10
• Study First Posted: 2014-02-12
• Primary Completion: 2016-03
• Study Completion: 2016-03
• Status Verified: 2016-10
• Last Update Submitted: 2016-10-25
• Last Update Posted: 2016-10-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 105

Inclusion Criteria

• ambulatory patient
• imaging suggestive of lung cancer
• written informed consent
• able to complete questionnaires

Exclusion Criteria

• solitary pulmonary nodule
• previous diagnosis of cancer

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
longitudinal assessment of illness perception	at time of suspected lung cancer, at time of diagnosis, at time of treatment start, 4 weeks after treatment start	patient reported questionnaire (Brief-Illness Perception questionnaire)
duration of diagnostic phase and period between diagnosis and treatment start	date of suspected lung cancer, date communication of diagnosis, date of treatment start
longitudinal assessment of distress	at time of suspected lung cancer, at time of diagnosis, at time of treatment start, 4 weeks after treatment start	patient reported questionnaire (distress barometer)
longitudinal assessment of quality of life	at time of suspected lung cancer, at time of diagnosis, at time of treatment start, 4 weeks after treatment start	patient reported questionnaire (EORTC QLQ-C30 + lung cancer module)

Secondary Outcome Measures

Name	Time	Method
explore which factors are associated with distress, quality of life and illness perception	first visit suspected lung cancer, communication of diagnosis, treatment start, 4 weeks after treatment start	potential associated factors include patient demographic characteristics, performed diagnostic procedures, disease and treatment characteristics

Trial Locations

Locations (8)

Algemeen Stedelijk Ziekenhuis Aalst; 🇧🇪 Aalst, Belgium

AZ Monica; 🇧🇪 Antwerpen, Belgium

Gasthuis Zusters Antwerpen; 🇧🇪 Antwerpen, Belgium

AZ St Jozef; 🇧🇪 Bornem, Belgium

Universiteit Antwerpen; 🇧🇪 Antwerpen, Belgium

Ziekenhuis Netwerk Antwerpen; 🇧🇪 Antwerpen, Belgium

AZ Maria Middelares Sint Jozef; 🇧🇪 Gent, Belgium

AZ Herentals; 🇧🇪 Herentals, Belgium