Quality of Life in Colorectal (ex-)Cancer Patients, Based on the Belgian Cancer Registry.

Colorectal Cancer Clinical Trial

— QOLColorect  

Official title:

Quality of Life in (ex-)Cancer Patients, Based on the Belgian Cancer Registry. Pilot Study: Quality of Life in Colorectal (ex-)Cancer Patients.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02545725
• Other study ID #: S57073
• Status: Completed
• Phase: N/A
• First received: September 1, 2015
• Last updated: September 8, 2015
• Start date: April 2015
• Est. completion date: August 2015

Study information

• Verified date: September 2015
• Source: Belgian Cancer Registry
• Contact: n/a
• Is FDA regulated: No
• Health authority: Belgium: Ethics Committee
• Study type: Observational

Clinical Trial Summary

This study is collecting data on quality of life, (care)needs and socio-economic factors in colorectal (ex-)cancer patients via a written questionnaire completed by the patient him/herself. The collected data will be linked with the patient- and tumour characteristics available in the database of the Belgian Cancer Registry and with the facturation data supplying information about diagnostic techniques and performed treatments (available via the insurance companies).

Based on the selection criteria, 1220 patients were finally selected from the database of the Belgian Cancer Registry. These patients received an invitation letter by regular mail, a detailed questionnaire and an informed consent.

The questionnaire contains topics as sociodemographic, life style, comorbidity, satisfaction with the provided information, care needs, quality of life, anxiety and depression, financial situation etc.

The patients were asked to complete the questionnaire and send it back, together with the signed informed consent, to the study-collaborators.

After 2-4 weeks, a reminder was sent. At that time, a reply card was added. If a patient doesn't want to participate in this study, a reason can be mentioned on the reply card.

The collected data are linked with the clinical data. The dataset will be coded before analyses will start.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1220
• Est. completion date: August 2015
• Est. primary completion date: August 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 90 Years

Eligibility

Inclusion Criteria:

• Invasive colorectal cancer (ICD-10: C18-C19-C20)

• Patient knows his/her diagnosis of cancer

• Incidence in 2008, 2009 or 2010

• The patient is at least 18 years at diagnosis

• The patient is maximal 90 years when completing the questionnaire

• The patient lives in Flanders and speaks Dutch

• The patient is treated/followed by 1 of the 7 participating hospitals

• The patient is able to complete the questionnaire him/herself (no cognitive problems)

Exclusion Criteria:

• More than 1 invasive tumour diagnosed

Study Design

Observational Model: Cohort, Time Perspective: Retrospective

Related Conditions & MeSH terms

• Colorectal Cancer
• Colorectal Neoplasms
• Quality of Life

Intervention

Other:
• Questionnaire on Quality of Life
The patients were asked to complete a questionnaire on Quality of Life

Locations

Country	Name	City	State
Belgium	Belgian Cancer Registry	Brussels	Koningsstraat 215 b7

Sponsors (2)

Lead Sponsor	Collaborator
Elizabeth Van Eycken	Flemish League Against Cancer

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Questionnaire on Quality of Life		5-8 years after diagnosis	No
Primary	Questionnaire on Quality of Life		At the moment of diagnosis and primary treatment (until +/- 1 year after diagnosis)	No

External Links

•   Belgian Cancer Registry
•   Website of the Study QOL in colorectal cancer patients
•   Website of the Study QOL in colorectal cancer patients