- ICH GCP
- Amerikanska kliniska prövningsregistret
- Klinisk prövning 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.
Studieöversikt
Status
Betingelser
Intervention / Behandling
Studietyp
Inskrivning (Faktisk)
Kontakter och platser
Studieorter
-
-
Koningsstraat 215 b7
-
Brussels, Koningsstraat 215 b7, Belgien, 1210
- Belgian Cancer Registry
-
-
Deltagandekriterier
Urvalskriterier
Åldrar som är berättigade till studier
Tar emot friska volontärer
Kön som är behöriga för studier
Testmetod
Studera befolkning
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.
Beskrivning
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
Studieplan
Hur är studien utformad?
Designdetaljer
Vad mäter studien?
Primära resultatmått
Resultatmått |
Tidsram |
---|---|
Questionnaire on Quality of Life
Tidsram: 5-8 years after diagnosis
|
5-8 years after diagnosis
|
Questionnaire on Quality of Life
Tidsram: 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)
|
Samarbetspartners och utredare
Sponsor
Samarbetspartners
Utredare
- Studierektor: Elizabeth Van Eycken, Director Belgian Cancer Registry
Publikationer och användbara länkar
Studieavstämningsdatum
Studera stora datum
Studiestart
Primärt slutförande (Faktisk)
Avslutad studie (Faktisk)
Studieregistreringsdatum
Först inskickad
Först inskickad som uppfyllde QC-kriterierna
Första postat (Uppskatta)
Uppdateringar av studier
Senaste uppdatering publicerad (Uppskatta)
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
Senast verifierad
Mer information
Termer relaterade till denna studie
Nyckelord
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- S57073
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