Clinical trial NCT02545725: Quality of Life in Colorectal (ex-)Cancer Patients, Based on the Belgian Cancer Registry.
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.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Colorectal Cancer
Quality of Life
Keywords: Colorectal Cancer
Quality of life
Questionnaires
Lead sponsor: Belgian Cancer Registry
Sponsor class: OTHER
Collaborators: name: Flemish League Against Cancer
First posted: 2015-09-10
Enrollment: 1220
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
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.

Brief 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.


Eligibility criteria: 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

Primary outcomes:
measure: Questionnaire on Quality of Life
timeFrame: 5-8 years after diagnosis
measure: Questionnaire on Quality of Life
timeFrame: At the moment of diagnosis and primary treatment (until +/- 1 year after diagnosis)
Secondary outcomes:
Other outcomes:
Locations:
city: Brussels
country: Belgium
facility: Belgian Cancer Registry
state: Koningsstraat 215 b7
Study officials:
affiliation: Director Belgian Cancer Registry
name: Elizabeth Van Eycken
role: STUDY_DIRECTOR
References: