Colorectal CancerQOLColorectNCT02545725
Quality of Life in Colorectal (ex-)Cancer Patients, Based on the Belgian Cancer Registry.
An observational study of Colorectal Cancer and Quality of Life, run by Elizabeth Van Eycken at 1 site in Belgium.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Colorectal Cancer, Quality of Life
- What is being tested?
- Questionnaire on Quality of Life
- How many people
- 1,220 participants
- Where
- 1 siteBelgium
- Study dates
- Apr 2015to Aug 2015
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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)
Who cannot join
- More than 1 invasive tumour diagnosed
Trial locations and contacts
1 site in 1 country.
About this study
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.
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.
Read more
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.
- Conditions
- Colorectal Cancer, Quality of Life
- Being tested
- Questionnaire on Quality of Life
- Keywords
- Colorectal Cancer, Quality of life, Questionnaires
- Medical subject headings
- Colorectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Questionnaire on Quality of LifeOther
The patients were asked to complete a questionnaire on Quality of Life
What is being measured
The primary outcome is the main question the study is designed to answer.
Questionnaire on Quality of Life
Measured: 5-8 years after diagnosis
Questionnaire on Quality of Life
Measured: At the moment of diagnosis and primary treatment (until +/- 1 year after diagnosis)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Sep 2015 (estimated)
- Study startApr 2015
- Primary completionAug 2015
- Study completionAug 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Colorectal CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 1,220 participants (actual)
Sponsor and investigators
- Lead sponsor
- Elizabeth Van Eycken
- Sponsor type
- University, hospital or other
- Collaborators
- Flemish League Against Cancer
- Responsible party
- Sponsor-investigator, Elizabeth Van Eycken, Belgian Cancer Registry
- Investigators
- Elizabeth Van Eycken, Study director, Director Belgian Cancer Registry
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02545725
- Sponsor's protocol ID
- S57073
- Acronym
- QOLColorect
- Status last verified
- Sep 2015
- First submitted
- 1 Sep 2015
- Last updated
- 10 Sep 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Sep 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT02545725
- Acronym / sponsor ID
- QOLColorect / S57073
- Conditions
- Colorectal Cancer, Quality of Life
- Keywords
- Colorectal Cancer, Quality of life, Questionnaires
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,220 participants (actual)
- Lead sponsor
- Elizabeth Van EyckenUniversity, hospital or other
- Collaborators
- Flemish League Against Cancer
- Study start
- Apr 2015
- Primary completion
- Aug 2015 (actual)
- Study completion
- Aug 2015 (actual)
- First posted
- 10 Sep 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (1 listed)
- More than 1 invasive tumour diagnosed
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Questionnaire on Quality of LifeThe patients were asked to complete a questionnaire on Quality of Life | Other | – |
Primary outcome
Questionnaire on Quality of Life
Time frame: 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)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Sep 2015.
- Belgian Cancer RegistryLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Elizabeth Van Eycken study director
Director Belgian Cancer Registry
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Colorectal Cancer and Quality of Life, run by Elizabeth Van Eycken at 1 site in Belgium.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Sep 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Questionnaire on Quality of Life (time frame: 5-8 years after diagnosis). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Sep 2015.