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Validation of an EORTC Quality of Life Questionnaire Module for Patients With Colorectal Cancer


N/A
18 Years
N/A
Not Enrolling
Both
Colorectal Cancer

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Trial Information

Validation of an EORTC Quality of Life Questionnaire Module for 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.

Inclusion 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

Type of Study:

Observational

Study Design:

N/A

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)

Principal Investigator

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

Investigator Role:

Study Chair

Investigator Affiliation:

University Hospitals Bristol NHS Trust

Authority:

United States: Federal Government

Study ID:

CDR0000574769

NCT ID:

NCT00564694

Start Date:

May 2007

Completion Date:

Related Keywords:

  • Colorectal Cancer
  • 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
  • Colorectal Neoplasms

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