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

NCT02060877 | Completed

• 2 other identifiers: TOGA-2013B300201419606
• Study Type: observational
• Target: 105
• Locations: 1 country
• Sites: 8

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

Conditions

Suspected Lung Cancer

Keywords

suspected lung cancer; diagnostic work-up

Outcome Measures

Primary Outcomes (4)

• longitudinal assessment of distress

  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

  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

  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

  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

  first visit suspected lung cancer, communication of diagnosis, treatment start, 4 weeks after treatment start

Study Arms (1)

patients suspected of having lung cancer

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

Other: observational study: use of patient questionnaires

Interventions

observational study: use of patient questionnaires OTHER

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

patients suspected of having lung cancer

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

patients with abnormal imaging suggestive of lung cancer consulting a pulmonologist

You may qualify if:

• ambulatory patient
• imaging suggestive of lung cancer
• written informed consent
• able to complete questionnaires

You may not qualify if:

• solitary pulmonary nodule
• previous diagnosis of cancer

Sponsors & Collaborators

• Universiteit Antwerpen: lead
• End-of-Life Research Group: collaborator

Study Sites (8)

Algemeen Stedelijk Ziekenhuis Aalst

Aalst, Belgium

Location

AZ Monica

Antwerp, Belgium

Location

Gasthuis Zusters Antwerpen

Antwerp, Belgium

Location

Universiteit Antwerpen

Antwerp, Belgium

Location

Ziekenhuis Netwerk Antwerpen

Antwerp, Belgium

Location

AZ St Jozef

Bornem, Belgium

Location

AZ Maria Middelares Sint Jozef

Ghent, Belgium

Location

AZ Herentals

Herentals, Belgium

Location

Study Officials

• Paul Van Royen

  Universiteit Antwerpen

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Study Coordinator Thoracale Oncologie Groep Antwerpen

Study Record Dates

• First Submitted: February 4, 2014
• First Posted: February 12, 2014
• Study Start: February 1, 2014
• Primary Completion: March 1, 2016
• Study Completion: March 1, 2016
• Last Updated: October 27, 2016

Record last verified: 2016-10

Data Sharing

• IPD Sharing: Will not share

Locations

BE (8)