Colorectal Cancer Clinical Trial
Official title:
Validation of an EORTC Quality of Life Questionnaire Module for 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.
OBJECTIVES:
- 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.
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N/A
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