Studying a Quality of Life Questionnaire in Patients With Colorectal Cancer

This study has been completed.
Sponsor:
Information provided by:
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00564694
First received: November 27, 2007
Last updated: October 28, 2013
Last verified: August 2009

November 27, 2007
October 28, 2013
May 2007
June 2009   (final data collection date for primary 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)
Same as current
Complete list of historical versions of study NCT00564694 on ClinicalTrials.gov Archive Site
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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.

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.

Observational
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Colorectal Cancer
  • Procedure: psychosocial assessment and care
  • Procedure: quality-of-life assessment
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
350
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June 2009   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United Kingdom,   France,   Germany
 
NCT00564694
CDR0000574769, EORTC-QLQ-CR29, EU-20783
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National Cancer Institute (NCI)
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Study Chair: Jane Blazeby, MB, CHB, FRCS, BSc, MD University Hospitals Bristol NHS Trust
National Cancer Institute (NCI)
August 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP