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

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

• Ages 18 years and older
• All sexes
• No healthy volunteers
• Adult, Older adult

Study population: patients with abnormal imaging suggestive of lung cancer consulting a pulmonologist

Trial locations and contacts

8 sites in 1 country.

About this study

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

Conditions

Suspected Lung Cancer

Being tested

observational study: use of patient questionnaires

Keywords

suspected lung cancer, diagnostic work-up

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

• observational study: use of patient questionnairesOther

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

What is being measured

The primary outcome is the main question the study is designed to answer.

1. longitudinal assessment of distress

   patient reported questionnaire (distress barometer)

   Measured: at time of suspected lung cancer, at time of diagnosis, at time of treatment start, 4 weeks after treatment start

2. longitudinal assessment of quality of life

   patient reported questionnaire (EORTC QLQ-C30 + lung cancer module)

   Measured: at time of suspected lung cancer, at time of diagnosis, at time of treatment start, 4 weeks after treatment start

3. longitudinal assessment of illness perception

   patient reported questionnaire (Brief-Illness Perception questionnaire)

   Measured: at time of suspected lung cancer, at time of diagnosis, at time of treatment start, 4 weeks after treatment start

4. duration of diagnostic phase and period between diagnosis and treatment start

   Measured: date of suspected lung cancer, date communication of diagnosis, date of treatment start

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

1. First posted12 Feb 2014 (estimated)
2. Study startFeb 2014
3. Primary completionMar 2016
4. Study completionMar 2016

Resources

• Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
• Other trials for Suspected Lung CancerStudies of the same condition, open and under way.
• What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.