Studying a Quality of Life Questionnaire in Patients With Colorectal Cancer

National Cancer Institute (NCI)

Status: Completed

Conditions: Colorectal Cancer

Treatments: Procedure: quality-of-life assessment; Procedure: psychosocial assessment and care

Study type: Observational

Funder types: NIH

Identifiers

NCT00564694

EU-20783

CDR0000574769

EORTC-QLQ-CR29

Details and patient eligibility

About

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.

Full 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.

Enrollment: 350 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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