Quality of Life in Colorectal (ex-)Cancer Patients, Based... | NCT02545725

Studies
Quality of Life in Colorectal (ex-)Cancer Patients, Based on the Belgian Cancer Registry.

NCT02545725

Sponsor

Elizabeth Van Eycken

Status

Completed

Last Update Posted

Sep 10, 2015Estimated

Enrollment

1,220Actual

Phase

Not provided

Conditions

Colorectal Cancer
Quality of Life

Interventions

Questionnaire on Quality of Life

Countries

Belgium

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Sep 2015

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Apr 2015

Primary Completion Date

Aug 2015Actual

Completion Date

Aug 2015Actual

First Submitted Date

Sep 1, 2015

First Submission Date that Met QC Criteria

Sep 8, 2015

First Posted Date

Sep 10, 2015Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Sep 8, 2015

Last Update Posted Date

Sep 10, 2015Estimated

Name	Class
Flemish League Against Cancer	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

1,220Actual

Arms/Interventions Module

Arm Groups

Not provided

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Questionnaire on Quality of Life	Other	The patients were asked to complete a questionnaire on Quality of Life

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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)

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

90 Years

Standard Ages

AdultOlder 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.

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Elizabeth Van Eycken	Director Belgian Cancer Registry	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Belgian Cancer Registry		Brussels	Koningsstraat 215 B7	1210	Belgium

Label	URL
Belgian Cancer Registry	View source

Condition Browse Module

MeSH Terms

ID	Term
D015179	Colorectal Neoplasms

Ancestor Terms

ID	Term
D007414	Intestinal Neoplasms
D005770	Gastrointestinal Neoplasms
D004067	Digestive System Neoplasms
D009371	Neoplasms by Site

Browse Leaves

Not provided

Browse Branches

Not provided