Studying a Quality of Life Questionnaire in Patients With Colorectal Cancer
RATIONALE: Collecting information about the quality of life of patients with colorectal cancer may help doctors learn more about the disease.
PURPOSE: This clinical trial is studying the European Organization of Research for the Treatment of Cancer (EORTC) quality-of-life-questionnaire in patients with colorectal cancer.
|Colorectal Cancer||Procedure: psychosocial assessment and care Procedure: quality-of-life assessment|
|Official Title:||Validation of an EORTC Quality of Life Questionnaire Module for Patients With Colorectal Cancer|
- Reliability and clinical and psychometric validity of the European Organization of Research for the Treatment of Cancer (EORTC) quality of life questionnaire (QLQ-CR29)
|Study Start Date:||May 2007|
|Primary Completion Date:||June 2009 (Final data collection date for primary outcome measure)|
- To test the reliability and clinical and psychometric validity of the European Organization of Research for the Treatment of Cancer (EORTC) quality of life questionnaire (QLQ-CR29) in an international sample of patients with colorectal cancer.
OUTLINE: This is a multicenter study. Patients are stratified into predetermined clinically distinct groups (colon cancer after surgery vs colon cancer undergoing adjuvant chemotherapy vs rectal cancer undergoing neoadjuvant radiotherapy vs rectal cancer after anterior resection with temporary stoma vs rectal cancer after abdominoperineal excision of rectum vs colorectal cancer undergoing palliative chemotherapy).
Quality-of-life data is collected alongside standard outcomes in patients undergoing treatment for colorectal cancer. Patients complete the European Organization of Research for the Treatment of Cancer (EORTC) quality of life questionnaire (QLQ-C30), the revised colorectal cancer module (QLQ-CR29), case report forms for clinical and sociodemographic data, and a debriefing questionnaire at different time points before, during, and after treatment. Some patients complete more sets of the same questionnaire at later time points to assess sensitivity to change over time and test-retest reliability. Reliability, and clinical and psychometric validity of the questionnaires are assessed by correlation analyses, exploration of known group comparisons, and responsiveness to clinical changes.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00564694
|Centre Alexis Vautrin|
|Vandoeuvre-les-Nancy, France, 54511|
|Charite University Medical Center of Berlin|
|Berlin, Germany, D-13347|
|Klinikum der Universitaet Regensburg|
|Regensburg, Germany, D-93053|
|Basingstoke and North Hampshire NHS Foundation Trust|
|Basingstoke, England, United Kingdom, RG24 9NA|
|Bristol Haematology and Oncology Centre|
|Bristol, England, United Kingdom, BS2 8ED|
|Study Chair:||Jane Blazeby, MB, CHB, FRCS, BSc, MD||University Hospitals Bristol NHS Foundation Trust|