Studying a Quality of Life Questionnaire in Patients With Colorectal Cancer - Full Text View

Sponsored by:	European Organization for Research and Treatment of Cancer
Information provided by:	National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:	NCT00564694

Purpose

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.

Condition	Intervention
Colorectal Cancer	Procedure: psychosocial assessment and care Procedure: quality-of-life assessment

MedlinePlus related topics: Cancer Colorectal Cancer

U.S. FDA Resources

Study Type:	Observational
Official Title:	Validation of an EORTC Quality of Life Questionnaire Module for Patients With Colorectal Cancer

Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:

Reliability and clinical and psychometric validity of the European Organization of Research for the Treatment of Cancer (EORTC) quality of life questionnaire (QLQ-CR29)

Estimated Enrollment:	350
Study Start Date:	May 2007

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

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00564694

Locations

France
Centre Alexis Vautrin	Recruiting
Vandoeuvre-les-Nancy, France, 54511
Contact: Contact Person 33-3-8359-8400
Germany
Charite University Medical Center of Berlin	Recruiting
Berlin, Germany, D-13347
Contact: Contact Person 49-304-056-6725
Klinikum der Universitaet Regensburg	Recruiting
Regensburg, Germany, D-93053
Contact: Contact Person 49-941-944-5800
United Kingdom, England
Basingstoke and North Hampshire NHS Foundation Trust	Recruiting
Basingstoke, England, United Kingdom, RG24 9NA
Contact: Contact Person 44-125-631-4793
Bristol Haematology and Oncology Centre	Recruiting
Bristol, England, United Kingdom, BS2 8ED
Contact: Contact Person 44-117-928-3074

Sponsors and Collaborators

European Organization for Research and Treatment of Cancer

Investigators

Study Chair:

Jane Blazeby, MB, CHB, FRCS, BSc, MD

University Hospitals Bristol NHS Trust

More Information

Additional Information:

Clinical trial summary from the National Cancer Institute's PDQ® database This link exits the ClinicalTrials.gov site

No publications provided

Study ID Numbers:	CDR0000574769, EORTC-QLQ-CR29, EU-20783
Study First Received:	November 27, 2007
Last Updated:	February 24, 2009
ClinicalTrials.gov Identifier:	NCT00564694 History of Changes
Health Authority:	Unspecified

Keywords provided by National Cancer Institute (NCI):

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

Study placed in the following topic categories:

Digestive System Neoplasms
Rectal Neoplasms
Gastrointestinal Diseases
Colonic Diseases
Rectal Neoplasm
Quality of Life
Intestinal Diseases
Rectal Diseases

Recurrence
Intestinal Neoplasms
Rectal Cancer
Digestive System Diseases
Gastrointestinal Neoplasms
Adenocarcinoma
Colorectal Neoplasms

Additional relevant MeSH terms:

Neoplasms
Digestive System Diseases
Neoplasms by Site
Digestive System Neoplasms
Gastrointestinal Diseases
Colonic Diseases

Gastrointestinal Neoplasms
Intestinal Diseases
Rectal Diseases
Intestinal Neoplasms
Colorectal Neoplasms

ClinicalTrials.gov processed this record on May 07, 2009