Suspected Lung CancerDIADISSNCT02060877
Distress and Quality of Life During the Diagnostic Phase of a Suspected Serious Lung Disease
An observational study of Suspected Lung Cancer, run by Universiteit Antwerpen at 8 sites in Belgium.
Trial 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 Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Suspected Lung Cancer
- What is being tested?
- observational study: use of patient questionnaires
- How many people
- 105 participants
- Where
- 8 sitesBelgium
- Study dates
- Feb 2014to Mar 2016
- Phase
- Observational
- Are there results?
- None posted in the registry
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
Who may be able to join
- ambulatory patient
- imaging suggestive of lung cancer
- written informed consent
- able to complete questionnaires
Who cannot join
- solitary pulmonary nodule
- previous diagnosis of cancer
Trial locations and contacts
8 sites in 1 country.
8 sites in 1 country
Belgium8 sites
Algemeen Stedelijk Ziekenhuis Aalst
Aalst
AZ Monica
Antwerp
Gasthuis Zusters Antwerpen
Antwerp
Universiteit Antwerpen
Antwerp
Ziekenhuis Netwerk Antwerpen
Antwerp
AZ St Jozef
Bornem
AZ Maria Middelares Sint Jozef
Ghent
AZ Herentals
Herentals
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
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
Read the 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.
- 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
| Study group | Role | What they receive |
|---|---|---|
| patients suspected of having lung cancer | observational study, there is no study intervention, only patient questionnaires Receives: Other: observational study: use of patient questionnaires |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
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
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
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
Secondary outcomes (1)
explore which factors are associated with distress, quality of life and illness perception
potential associated factors include patient demographic characteristics, performed diagnostic procedures, disease and treatment characteristics
Measured: first visit suspected lung cancer, communication of diagnosis, treatment start, 4 weeks after treatment start
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Feb 2014 (estimated)
- Study startFeb 2014
- Primary completionMar 2016
- 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.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 105 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universiteit Antwerpen
- Sponsor type
- University, hospital or other
- Collaborators
- End-of-Life Research Group
- Responsible party
- Principal investigator, Kathleen Belien, Universiteit Antwerpen
- Investigators
- Paul Van Royen, Principal investigator, Universiteit Antwerpen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02060877
- Sponsor's protocol ID
- TOGA-2013
- Other IDs
- B300201419606
- Acronym
- DIADISS
- Status last verified
- Oct 2016
- First submitted
- 4 Feb 2014
- Last updated
- 27 Oct 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Oct 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- How Burdensome is the Diagnostic Phase ? Distress and Quality of Life in Patients Suspected of Having a (Serious) Lung Disease
- ClinicalTrials.gov ID
- NCT02060877
- Acronym / sponsor ID
- DIADISS / TOGA-2013
- Conditions
- Suspected Lung Cancer
- Keywords
- suspected lung cancer, diagnostic work-up
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 105 participants (actual)
- Lead sponsor
- Universiteit AntwerpenUniversity, hospital or other
- Collaborators
- End-of-Life Research Group
- Study start
- Feb 2014
- Primary completion
- Mar 2016 (actual)
- Study completion
- Mar 2016 (actual)
- First posted
- 12 Feb 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| patients suspected of having lung cancer | – | Other: observational study: use of patient questionnairesobservational study, there is no study intervention, only patient questionnaires |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- patients with abnormal imaging suggestive of lung cancer consulting a pulmonologist
Key inclusion criteria (4 listed)
- ambulatory patient
- imaging suggestive of lung cancer
- written informed consent
- able to complete questionnaires
Key exclusion criteria (2 listed)
- solitary pulmonary nodule
- previous diagnosis of cancer
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| observational study: use of patient questionnairesobservational study, there is no study intervention, only patient questionnaires | Other | patients suspected of having lung cancer |
Primary outcome
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)
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)
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)
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
1 secondary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Oct 2016.
- Individual participant dataSharing planned: No
Related trials for Suspected Lung Cancer
Not yet recruitingEarly Phase 1
Implantable Microdevices for in Situ Evaluation of Drug Responses in Lung Cancer
Lung Cancer, Mesothelioma
Not yet recruitingObservational study
Nodify Lung Testing for Pulmonary Nodules
Indeterminate Pulmonary Nodule
Not yet recruitingObservational study
Right Ventricular Afterload Indices in Lung Surgery
Lung Cancer (Suspected or Confirmed), Thoracoscopic Lobectomy
RecruitingObservational study
Molecular Analysis of Suspected or High-Risk Lung Cancer to Drive Individualized Care
Lung Carcinoma, Metastatic Malignant Neoplasm in the Lung
Not yet recruitingPhase 4
CYTALUX Dose Extension Study
Cancer in the Lung, Ovarian Cancer
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Paul Van Royen principal investigator
Universiteit Antwerpen
8 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Suspected Lung Cancer, run by Universiteit Antwerpen at 8 sites in Belgium.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Oct 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 sites in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Oct 2016.