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

October 25, 2016 updated by: Kathleen Belien, Universiteit Antwerpen

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

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

Study Overview

Status

Completed

Conditions

Intervention / 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 Type

Observational

Enrollment (Actual)

105

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Belgium
      • Aalst, Belgium
        • Algemeen Stedelijk Ziekenhuis Aalst
      • Antwerpen, Belgium
        • AZ Monica
      • Antwerpen, Belgium
        • Ziekenhuis Netwerk Antwerpen
      • Antwerpen, Belgium
        • Gasthuis Zusters Antwerpen
      • Antwerpen, Belgium
        • Universiteit Antwerpen
      • Bornem, Belgium
        • AZ St Jozef
      • Gent, Belgium
        • AZ Maria Middelares Sint Jozef
      • Herentals, Belgium
        • AZ Herentals

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

patients with abnormal imaging suggestive of lung cancer consulting a pulmonologist

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
patients suspected of having lung cancer
observational study, there is no study intervention, only patient questionnaires
Other: observational study: use of patient questionnaires
observational study, there is no study intervention, only patient questionnaires

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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)
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
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)
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
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)
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
Time Frame: date of suspected lung cancer, date communication of diagnosis, date of 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
Time Frame: 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
first visit suspected lung cancer, communication of diagnosis, treatment start, 4 weeks after treatment start

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Universiteit Antwerpen

Collaborators

End-of-Life Research Group

Investigators

  • Principal Investigator: Paul Van Royen, Universiteit Antwerpen

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2014

Primary Completion (Actual)

March 1, 2016

Study Completion (Actual)

March 1, 2016

Study Registration Dates

First Submitted

February 4, 2014

First Submitted That Met QC Criteria

February 10, 2014

First Posted (Estimate)

February 12, 2014

Study Record Updates

Last Update Posted (Estimate)

October 27, 2016

Last Update Submitted That Met QC Criteria

October 25, 2016

Last Verified

October 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • TOGA-2013
  • B300201419606 (Registry Identifier: Belgisch registratienummer)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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