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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Suspected Lung Cancer

Intervention / Treatment
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* Other: observational study: use of patient questionnaires


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| patients suspected of having lung cancer<br>observational study, there is no study intervention, only patient questionnaires | Other: observational study: use of patient questionnaires<br>* observational study, there is no study intervention, only patient questionnaires<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| 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 | 
| 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 | 
| duration of diagnostic phase and period between diagnosis and treatment start |  | date of suspected lung cancer, date communication of diagnosis, date of treatment start | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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suspected lung cancer, diagnostic work-up