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| ID | Type | Description | Link |
|---|---|---|---|
| EORTC-QLQ-CR29 | |||
| EU-20783 |
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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:
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.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| psychosocial assessment and care | Procedure | |||
| quality-of-life assessment | Procedure |
| Measure | Description | Time Frame |
|---|---|---|
| Reliability and clinical and psychometric validity of the European Organization of Research for the Treatment of Cancer (EORTC) quality of life questionnaire (QLQ-CR29) |
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DISEASE CHARACTERISTICS:
PATIENT CHARACTERISTICS:
PRIOR CONCURRENT THERAPY:
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| Name | Affiliation | Role |
|---|---|---|
| Jane Blazeby, MB, CHB, FRCS, BSc, MD | University Hospitals Bristol and Weston NHS Foundation Trust | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Centre Alexis Vautrin | Vandœuvre-lès-Nancy | 54511 | France | |||
| Charite University Medical Center of Berlin |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 21239355 | Result | 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. | |
| 22166739 | Result |
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| ID | Term |
|---|---|
| D015179 | Colorectal Neoplasms |
| D003110 | Colonic Neoplasms |
| D012004 | Rectal Neoplasms |
| ID | Term |
|---|---|
| D007414 | Intestinal Neoplasms |
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
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| ID | Term |
|---|---|
| D000067250 | Psychiatric Rehabilitation |
| ID | Term |
|---|---|
| D012046 | Rehabilitation |
| D013812 | Therapeutics |
| D006296 | Health Services |
| D005159 | Health Care Facilities Workforce and Services |
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| Berlin |
| D-13347 |
| Germany |
| Klinikum der Universitaet Regensburg | Regensburg | D-93053 | Germany |
| Basingstoke and North Hampshire NHS Foundation Trust | Basingstoke | England | RG24 9NA | United Kingdom |
| Bristol Haematology and Oncology Centre | Bristol | England | BS2 8ED | United Kingdom |
| 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. |
| 19765978 | Result | 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. |
| D009369 | Neoplasms |
| D004066 | Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D003108 | Colonic Diseases |
| D007410 | Intestinal Diseases |
| D012002 | Rectal Diseases |