- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02545725
Quality of Life in Colorectal (ex-)Cancer Patients, Based on the Belgian Cancer Registry. (QOLColorect)
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
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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Koningsstraat 215 b7
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Brussels, Koningsstraat 215 b7, Belgium, 1210
- Belgian Cancer Registry
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
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
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
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5-8 years after diagnosis
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Questionnaire on Quality of Life
Time Frame: At the moment of diagnosis and primary treatment (until +/- 1 year after diagnosis)
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At the moment of diagnosis and primary treatment (until +/- 1 year after diagnosis)
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Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Study Director: Elizabeth Van Eycken, Director Belgian Cancer Registry
Publications and helpful links
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
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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