Colorectal Cancer
Conditions
Keywords
adenocarcinoma of the colon, recurrent colon cancer, stage I colon cancer, stage II colon cancer, stage III colon cancer, stage IV colon cancer, adenocarcinoma of the rectum, recurrent rectal cancer, stage I rectal cancer, stage II rectal cancer, stage III rectal cancer, stage IV rectal cancer
Brief summary
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.
Detailed description
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.
Interventions
PROCEDUREpsychosocial assessment and care
PROCEDUREquality-of-life assessment
Sponsors
National Cancer Institute (NCI)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Reliability and clinical and psychometric validity of the European Organization of Research for the Treatment of Cancer (EORTC) quality of life questionnaire (QLQ-CR29) | — |
Countries
France, Germany, United Kingdom
Outcome results
None listed