NCT00564694

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.

Trial Health

85
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
350

participants targeted

Target at P75+ for all trials

Geographic Reach
3 countries

5 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2007

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

November 27, 2007

Completed
1 day until next milestone

First Posted

Study publicly available on registry

November 28, 2007

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2009

Completed
Last Updated

October 29, 2013

Status Verified

August 1, 2009

Enrollment Period

2.1 years

First QC Date

November 27, 2007

Last Update Submit

October 28, 2013

Conditions

Colorectal Cancer

Keywords

adenocarcinoma of the colonrecurrent colon cancerstage I colon cancerstage II colon cancerstage III colon cancerstage IV colon canceradenocarcinoma of the rectumrecurrent rectal cancerstage I rectal cancerstage II rectal cancerstage III rectal cancerstage IV rectal cancer

Outcome Measures

Primary Outcomes (1)

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

Interventions

psychosocial assessment and carePROCEDURE
quality-of-life assessmentPROCEDURE

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

Study Sites (5)

Centre Alexis Vautrin

Vandœuvre-lès-Nancy, 54511, France

Location

Charite University Medical Center of Berlin

Berlin, D-13347, Germany

Location

Klinikum der Universitaet Regensburg

Regensburg, D-93053, Germany

Location

Basingstoke and North Hampshire NHS Foundation Trust

Basingstoke, England, RG24 9NA, United Kingdom

Location

Bristol Haematology and Oncology Centre

Bristol, England, BS2 8ED, United Kingdom

Location

Related Publications (3)

  • 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.

    PMID: 21239355RESULT

  • 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.

    PMID: 22166739RESULT

  • 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.

    PMID: 19765978RESULT

MeSH Terms

Conditions

Colorectal NeoplasmsColonic NeoplasmsRectal Neoplasms

Interventions

Psychiatric Rehabilitation

Condition Hierarchy (Ancestors)

Intestinal NeoplasmsGastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesColonic DiseasesIntestinal DiseasesRectal Diseases

Intervention Hierarchy (Ancestors)

RehabilitationTherapeuticsHealth ServicesHealth Care Facilities Workforce and Services

Study Officials

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

    University Hospitals Bristol and Weston NHS Foundation Trust

    STUDY CHAIR

Study Design

Study Type
observational
Sponsor Type
NIH

Study Record Dates

First Submitted

November 27, 2007

First Posted

November 28, 2007

Study Start

May 1, 2007

Primary Completion

June 1, 2009

Last Updated

October 29, 2013

Record last verified: 2009-08

Locations

FR(1)DE(2)GB(2)