- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 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.
연구 개요
연구 유형
등록 (실제)
연락처 및 위치
연구 장소
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Koningsstraat 215 b7
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Brussels, Koningsstraat 215 b7, 벨기에, 1210
- Belgian Cancer Registry
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참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
샘플링 방법
연구 인구
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.
설명
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
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
기간 |
|---|---|
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Questionnaire on Quality of Life
기간: 5-8 years after diagnosis
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5-8 years after diagnosis
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Questionnaire on Quality of Life
기간: At the moment of diagnosis and primary treatment (until +/- 1 year after diagnosis)
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At the moment of diagnosis and primary treatment (until +/- 1 year after diagnosis)
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공동 작업자 및 조사자
수사관
- 연구 책임자: Elizabeth Van Eycken, Director Belgian Cancer Registry
간행물 및 유용한 링크
연구 기록 날짜
연구 주요 날짜
연구 시작
기본 완료 (실제)
연구 완료 (실제)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (추정)
연구 기록 업데이트
마지막 업데이트 게시됨 (추정)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .