NCT02545725

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,220

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Apr 2015

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2015

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2015

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

September 1, 2015

Completed
9 days until next milestone

First Posted

Study publicly available on registry

September 10, 2015

Completed
Last Updated

September 10, 2015

Status Verified

September 1, 2015

Enrollment Period

4 months

First QC Date

September 1, 2015

Last Update Submit

September 8, 2015

Conditions

Keywords

Colorectal CancerQuality of lifeQuestionnaires

Outcome Measures

Primary Outcomes (2)

  • Questionnaire on Quality of Life

    5-8 years after diagnosis

  • Questionnaire on Quality of Life

    At the moment of diagnosis and primary treatment (until +/- 1 year after diagnosis)

Interventions

The patients were asked to complete a questionnaire on Quality of Life

Eligibility Criteria

Age18 Years - 90 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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.

You may qualify if:

  • 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)

You may not qualify if:

  • More than 1 invasive tumour diagnosed

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Belgian Cancer Registry

Brussels, Koningsstraat 215 B7, 1210, Belgium

Location

Related Links

MeSH Terms

Conditions

Colorectal Neoplasms

Condition Hierarchy (Ancestors)

Intestinal NeoplasmsGastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesColonic DiseasesIntestinal DiseasesRectal Diseases

Study Officials

  • Elizabeth Van Eycken

    Director Belgian Cancer Registry

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Director Belgian Cancer Registry

Study Record Dates

First Submitted

September 1, 2015

First Posted

September 10, 2015

Study Start

April 1, 2015

Primary Completion

August 1, 2015

Study Completion

August 1, 2015

Last Updated

September 10, 2015

Record last verified: 2015-09

Locations