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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Universiteit Antwerpen

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
End-of-Life Research Group

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
February 1, 2014

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
March 1, 2016

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
March 1, 2016

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
February 4, 2014

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 10, 2014

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
February 12, 2014

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
October 27, 2016

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 25, 2016

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
October 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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