Clinical trial NCT02060877: Distress and Quality of Life During the Diagnostic Phase of a Suspected Serious Lung Disease
Official title: How Burdensome is the Diagnostic Phase ? Distress and Quality of Life in Patients Suspected of Having a (Serious) Lung Disease
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Suspected Lung Cancer
Keywords: suspected lung cancer
diagnostic work-up
Lead sponsor: Universiteit Antwerpen
Sponsor class: OTHER
Collaborators: name: End-of-Life Research Group
First posted: 2014-02-12
Enrollment: 105
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: patients with abnormal imaging suggestive of lung cancer consulting a pulmonologist

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.

Eligibility criteria: 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

Primary outcomes:
measure: longitudinal assessment of distress
timeFrame: at time of suspected lung cancer, at time of diagnosis, at time of treatment start, 4 weeks after treatment start
measure: longitudinal assessment of quality of life
timeFrame: at time of suspected lung cancer, at time of diagnosis, at time of treatment start, 4 weeks after treatment start
measure: longitudinal assessment of illness perception
timeFrame: at time of suspected lung cancer, at time of diagnosis, at time of treatment start, 4 weeks after treatment start
measure: duration of diagnostic phase and period between diagnosis and treatment start
timeFrame: date of suspected lung cancer, date communication of diagnosis, date of treatment start
Secondary outcomes:
measure: explore which factors are associated with distress, quality of life and illness perception
timeFrame: first visit suspected lung cancer, communication of diagnosis, treatment start, 4 weeks after treatment start
Other outcomes:
Locations:
city: Aalst
country: Belgium
facility: Algemeen Stedelijk Ziekenhuis Aalst
city: Antwerpen
country: Belgium
facility: AZ Monica
city: Antwerpen
country: Belgium
facility: Gasthuis Zusters Antwerpen
city: Antwerpen
country: Belgium
facility: Universiteit Antwerpen
city: Antwerpen
country: Belgium
facility: Ziekenhuis Netwerk Antwerpen
city: Bornem
country: Belgium
facility: AZ St Jozef
city: Gent
country: Belgium
facility: AZ Maria Middelares Sint Jozef
city: Herentals
country: Belgium
facility: AZ Herentals
Study officials:
affiliation: Universiteit Antwerpen
name: Paul Van Royen
role: PRINCIPAL_INVESTIGATOR
References: