Studying a Quality of Life Questionnaire in Patients With Colorectal Cancer

National Cancer Institute (NCI)350 enrolled

Overview

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.

Study Type

OBSERVATIONAL

Enrollment

350

Conditions

Colorectal Cancer

Interventions

psychosocial assessment and carePROCEDURE

quality-of-life assessmentPROCEDURE

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

DISEASE CHARACTERISTICS: * Histologically confirmed adenocarcinoma of the colon or rectum * No brain metastases or intracranial tumor extension with cognitive impairment PATIENT CHARACTERISTICS: * No limit on performance status * Able to understand the language of the questionnaire * No psychological, familial, sociological, or geographical condition potentially hampering compliance with the study protocol and follow-up schedule * No other concurrent malignancies except basal cell carcinoma of the skin PRIOR CONCURRENT THERAPY: * No prior participation in this study (in a different subgroup) * No concurrent participation in other quality of life studies that might interfere with this study

Locations (5)

Centre Alexis Vautrin

Vandœuvre-lès-Nancy, France

Charite University Medical Center of Berlin

Berlin, Germany

Klinikum der Universitaet Regensburg

Regensburg, Germany

Basingstoke and North Hampshire NHS Foundation Trust

Basingstoke, England, United Kingdom

Outcomes

Primary Outcomes

Reliability and clinical and psychometric validity of the European Organization of Research for the Treatment of Cancer (EORTC) quality of life questionnaire (QLQ-CR29)

Data from ClinicalTrials.gov

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