Clinical trial NCT00564694: Studying a Quality of Life Questionnaire in Patients With Colorectal Cancer
Official title: Validation of an EORTC Quality of Life Questionnaire Module for Patients With Colorectal Cancer
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Colorectal Cancer
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
Lead sponsor: National Cancer Institute (NCI)
Sponsor class: NIH
First posted: 2007-11-28
Enrollment: 350
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no

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.

Eligibility 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

Primary outcomes:
measure: Reliability and clinical and psychometric validity of the European Organization of Research for the Treatment of Cancer (EORTC) quality of life questionnaire (QLQ-CR29)
Secondary outcomes:
Other outcomes:
Locations:
city: Vandoeuvre-les-Nancy
country: France
facility: Centre Alexis Vautrin
city: Berlin
country: Germany
facility: Charite University Medical Center of Berlin
city: Regensburg
country: Germany
facility: Klinikum der Universitaet Regensburg
city: Basingstoke
country: United Kingdom
facility: Basingstoke and North Hampshire NHS Foundation Trust
state: England
city: Bristol
country: United Kingdom
facility: Bristol Haematology and Oncology Centre
state: England
Study officials:
affiliation: University Hospitals Bristol and Weston NHS Foundation Trust
name: Jane Blazeby, MB, CHB, FRCS, BSc, MD
role: STUDY_CHAIR
References:
citation: Arraras JI, Suarez J, Arias de la Vega F, Vera R, Asin G, Arrazubi V, Rico M, Teijeira L, Azparren J. The EORTC Quality of Life questionnaire for patients with colorectal cancer: EORTC QLQ-CR29 validation study for Spanish patients. Clin Transl Oncol. 2011 Jan;13(1):50-6. doi: 10.1007/s12094-011-0616-y.
citation: Nowak W, Tobiasz-Adamczyk B, Brzyski P, Salowka J, Kulis D, Richter P. Adaptation of quality of life module EORTC QLQ-CR29 for Polish patients with rectal cancer: initial assessment of validity and reliability. Pol Przegl Chir. 2011 Sep;83(9):502-10. doi: 10.2478/v10035-011-0078-5.
citation: Whistance RN, Conroy T, Chie W, Costantini A, Sezer O, Koller M, Johnson CD, Pilkington SA, Arraras J, Ben-Josef E, Pullyblank AM, Fayers P, Blazeby JM; European Organisation for the Research and Treatment of Cancer Quality of Life Group. Clinical and psychometric validation of the EORTC QLQ-CR29 questionnaire module to assess health-related quality of life in patients with colorectal cancer. Eur J Cancer. 2009 Nov;45(17):3017-26. doi: 10.1016/j.ejca.2009.08.014. Epub 2009 Sep 16.