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

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ClinicalTrials.gov Identifier: NCT02060877
Recruitment Status : Completed
First Posted : February 12, 2014
Last Update Posted : October 27, 2016
Sponsor:
Collaborator:
End-of-Life Research Group
Information provided by (Responsible Party):
Kathleen Belien, Universiteit Antwerpen

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

Condition or disease Intervention/treatment
Suspected Lung Cancer Other: observational study: use of patient questionnaires

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.

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Study Type : Observational
Actual Enrollment : 105 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: How Burdensome is the Diagnostic Phase ? Distress and Quality of Life in Patients Suspected of Having a (Serious) Lung Disease
Study Start Date : February 2014
Actual Primary Completion Date : March 2016
Actual Study Completion Date : March 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lung Diseases

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




Primary Outcome Measures :
  1. 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)

  2. 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)

  3. 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)

  4. 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 ]

Secondary Outcome Measures :
  1. 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



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
patients with abnormal imaging suggestive of lung cancer consulting a pulmonologist
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02060877


Locations
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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, Belgium
Sponsors and Collaborators
Universiteit Antwerpen
End-of-Life Research Group
Investigators
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Principal Investigator: Paul Van Royen Universiteit Antwerpen

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Responsible Party: Kathleen Belien, Study Coordinator Thoracale Oncologie Groep Antwerpen, Universiteit Antwerpen
ClinicalTrials.gov Identifier: NCT02060877     History of Changes
Other Study ID Numbers: TOGA-2013
B300201419606 ( Registry Identifier: Belgisch registratienummer )
First Posted: February 12, 2014    Key Record Dates
Last Update Posted: October 27, 2016
Last Verified: October 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Kathleen Belien, Universiteit Antwerpen:
suspected lung cancer
diagnostic work-up

Additional relevant MeSH terms:
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Lung Diseases
Respiratory Tract Diseases