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

Suspected Lung Cancer Clinical Trial

— DIADISS  

Official title:

How Burdensome is the Diagnostic Phase ? Distress and Quality of Life in Patients Suspected of Having a (Serious) Lung Disease

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02060877
• Other study ID #: TOGA-2013
• Secondary ID: B300201419606
• Status: Completed
• Phase: N/A
• First received: February 4, 2014
• Last updated: October 25, 2016
• Start date: February 2014
• Est. completion date: March 2016

Study information

• Verified date: October 2016
• Source: Universiteit Antwerpen
• Contact: n/a
• Is FDA regulated: No
• Health authority: Belgium: Ethics Committee
• Study type: Observational

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 105
• Est. completion date: March 2016
• Est. primary completion date: March 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Lung Diseases
• Lung Neoplasms
• Suspected Lung Cancer

Intervention

Other:
• observational study: use of patient questionnaires
observational study, there is no study intervention, only patient questionnaires

Locations

Country	Name	City	State
Belgium	Algemeen Stedelijk Ziekenhuis Aalst	Aalst
Belgium	AZ Monica	Antwerpen
Belgium	Gasthuis Zusters Antwerpen	Antwerpen
Belgium	Universiteit Antwerpen	Antwerpen
Belgium	Ziekenhuis Netwerk Antwerpen	Antwerpen
Belgium	AZ St Jozef	Bornem
Belgium	AZ Maria Middelares Sint Jozef	Gent
Belgium	AZ Herentals	Herentals

Sponsors (2)

Lead Sponsor	Collaborator
Universiteit Antwerpen	End-of-Life Research Group

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	longitudinal assessment of distress	patient reported questionnaire (distress barometer)	at time of suspected lung cancer, at time of diagnosis, at time of treatment start, 4 weeks after treatment start	No
Primary	longitudinal assessment of quality of life	patient reported questionnaire (EORTC QLQ-C30 + lung cancer module)	at time of suspected lung cancer, at time of diagnosis, at time of treatment start, 4 weeks after treatment start	No
Primary	longitudinal assessment of illness perception	patient reported questionnaire (Brief-Illness Perception questionnaire)	at time of suspected lung cancer, at time of diagnosis, at time of treatment start, 4 weeks after treatment start	No
Primary	duration of diagnostic phase and period between diagnosis and treatment start		date of suspected lung cancer, date communication of diagnosis, date of treatment start	No
Secondary	explore which factors are associated with distress, quality of life and illness perception	potential associated factors include patient demographic characteristics, performed diagnostic procedures, disease and treatment characteristics	first visit suspected lung cancer, communication of diagnosis, treatment start, 4 weeks after treatment start	No