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NCT Number: NCT02060877

Distress and Quality of Life During the Diagnostic Phase of a Suspected 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

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Key information

Conditions

Suspected Lung Cancer

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Algemeen Stedelijk Ziekenhuis Aalst, Aalst, Belgium

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

observational study: use of patient questionnaires

Other

observational study, there is no study intervention, only patient questionnaires

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Universiteit Antwerpen

Other

Collaborators

  • End-of-Life Research Group

Registry information

Official study title

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

Acronym: DIADISS

Important dates

Study start
2014
Primary completion
2016
Study completion
2016
First posted
Feb 12, 2014
Registry last updated
Oct 27, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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