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

September 8, 2015 updated by: Elizabeth Van Eycken

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

1220

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
    • Koningsstraat 215 b7
      • Brussels, Koningsstraat 215 b7, Belgium, 1210
        • Belgian Cancer Registry

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

Ages Eligible for Study

18 years to 90 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients of colorectal cancer (ICD-10: C18-C19-C20) with incidence in 2008-2010 were selected for this study. Patients are at least 18 years old at diagnosis and maximal 90 years old when completing the questionnaire.

Patients are living in Flanders, speak Dutch and are followed in 1 of the 7 participating hospitals.

The patients are able to complete the questionnaire themselves: patients with cognitive problems are excluded.

Description

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 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Questionnaire on Quality of Life
Time Frame: 5-8 years after diagnosis
5-8 years after diagnosis
Questionnaire on Quality of Life
Time Frame: At the moment of diagnosis and primary treatment (until +/- 1 year after diagnosis)
At the moment of diagnosis and primary treatment (until +/- 1 year after diagnosis)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Elizabeth Van Eycken

Collaborators

Flemish League Against Cancer

Investigators

  • Study Director: Elizabeth Van Eycken, Director Belgian Cancer Registry

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

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

April 1, 2015

Primary Completion (Actual)

August 1, 2015

Study Completion (Actual)

August 1, 2015

Study Registration Dates

First Submitted

September 1, 2015

First Submitted That Met QC Criteria

September 8, 2015

First Posted (Estimate)

September 10, 2015

Study Record Updates

Last Update Posted (Estimate)

September 10, 2015

Last Update Submitted That Met QC Criteria

September 8, 2015

Last Verified

September 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • S57073

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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