Studying a Quality of Life Questionnaire in Patients With Colorectal Cancer

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.

Study Overview

• Status: Completed
• Conditions: Colorectal Cancer
• Intervention / Treatment: Procedure: psychosocial assessment and care; Procedure: quality-of-life assessment

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.

• Study Type: Observational
• Enrollment (Anticipated): 350

Contacts and Locations

Study Locations

• France
  • Vandoeuvre-les-Nancy, France, 54511
    • Centre Alexis Vautrin
• Germany
  • Berlin, Germany, D-13347
    • Charite University Medical Center of Berlin
  • Regensburg, Germany, D-93053
    • Klinikum der Universitaet Regensburg
• United Kingdom
  • England
    • Basingstoke, England, United Kingdom, RG24 9NA
      • Basingstoke and North Hampshire NHS Foundation Trust
    • Bristol, England, United Kingdom, BS2 8ED
      • Bristol Haematology and Oncology Centre

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome 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)

Collaborators and Investigators

• Sponsor: National Cancer Institute (NCI)
• Investigators: Study Chair: Jane Blazeby, MB, CHB, FRCS, BSc, MD, University Hospitals Bristol and Weston NHS Foundation Trust

Publications and helpful links

General Publications

• 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start: May 1, 2007
• Primary Completion (Actual): June 1, 2009

Study Registration Dates

• First Submitted: November 27, 2007
• First Submitted That Met QC Criteria: November 27, 2007
• First Posted (Estimate): November 28, 2007

Study Record Updates

• Last Update Posted (Estimate): October 29, 2013
• Last Update Submitted That Met QC Criteria: October 28, 2013
• Last Verified: August 1, 2009

More Information

Terms related to this study

• Keywords: adenocarcinoma of the rectum; stage IV rectal cancer; stage IV colon cancer; adenocarcinoma of the colon; recurrent colon cancer; recurrent rectal cancer; stage III colon cancer; stage II rectal cancer; stage III rectal cancer; stage II colon cancer; stage I rectal cancer; stage I colon cancer
• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms; Neoplasms by Site; Gastrointestinal Neoplasms; Digestive System Neoplasms; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Intestinal Neoplasms; Rectal Diseases; Colorectal Neoplasms
• Other Study ID Numbers: CDR0000574769; EORTC-QLQ-CR29; EU-20783