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Clinical Trials/NCT02060877
NCT02060877
Completed
Not Applicable

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

Universiteit Antwerpen8 sites in 1 country105 target enrollmentFebruary 2014

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Suspected Lung Cancer
Sponsor
Universiteit Antwerpen
Enrollment
105
Locations
8
Primary Endpoint
longitudinal assessment of illness perception
Status
Completed
Last Updated
9 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
February 2014
End Date
March 2016
Last Updated
9 years ago
Study Type
Observational
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Kathleen Belien

Study Coordinator Thoracale Oncologie Groep Antwerpen

Universiteit Antwerpen

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

Outcomes

Primary Outcomes

longitudinal assessment of illness perception

Time Frame: 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

Time Frame: date of suspected lung cancer, date communication of diagnosis, date of treatment start

longitudinal assessment of distress

Time Frame: 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

Time Frame: 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 Outcomes

  • 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)

Study Sites (8)

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