Quality-Of-Life Assessment in Patients With Head and Neck Cancer Treated With Radiation Therapy
|ClinicalTrials.gov Identifier: NCT01210872|
Recruitment Status : Unknown
Verified September 2010 by National Cancer Institute (NCI).
Recruitment status was: Recruiting
First Posted : September 29, 2010
Last Update Posted : August 7, 2013
RATIONALE: Gathering information over time about patients' quality-of-life and satisfaction with care may help doctors plan the best treatment and help patients live more comfortably.
PURPOSE: This randomized clinical trial is studying quality-of-life assessment in patients with head and neck cancer treated with radiation therapy.
|Condition or disease||Intervention/treatment|
|Head and Neck Cancer||Other: questionnaire administration Procedure: quality-of-life assessment Procedure: standard follow-up care|
- To evaluate the impact of quality-of-life assessment in routine oncology practice on satisfaction with care, health-related quality-of-life, and toxicity in patients with primary nonmetastatic head and neck cancer treated with radiotherapy.
- To evaluate the feasibility of using quality-of-life tools in routine oncology practice.
- To evaluate the impact on the occurrence of toxicity.
- To determine the impact on overall survival.
- To study the concordance between the toxicity reported by the clinician and those reported by the patient quality-of-life questionnaires.
OUTLINE: Patients are stratified according to sex, tumor localization, and TNM stage. Patients are randomized to 1 of 2 arms.
- Arm I: Patients complete quality-of-life questionnaires (EORTC tools only, including EORTC QLQ-SAT32, EORTC QLQ-C30, and specific module QLQ-H&N35/Euroqol EQ-5D) before each consultation with the clinician for one year.
- Arm II: Patients undergo standard follow-up care comprising consultation with the clinician for one year.
After completion of study, patients are followed up every 3 months for 1 year and then at 2 years.
|Study Type :||Observational|
|Estimated Enrollment :||200 participants|
|Official Title:||Impact of Quality of Life Assessment in Routine Oncology Practice for Head and Neck's Cancer Patients, Treated by Radiotherapy: Impact on the Satisfaction With Care, the Health Related Quality of Life and on the Toxicity|
|Study Start Date :||September 2009|
|Estimated Primary Completion Date :||September 2013|
- Satisfaction of care (EORTC QLQ-SAT32)
- Quality of life (EORTC QLQ-C30 and specific module QLQ-H&N35/Euroqol EQ-5D)
- Toxicity (occurrence and length) according to NCI-CTC version 3.0
- Overall survival
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01210872
|Centre de Lutte Contre le Cancer Georges-Francois Leclerc||Recruiting|
|Dijon, France, 21079|
|Contact: Contact Person 33-3-8073-7784 firstname.lastname@example.org|
|Study Chair:||Philippe Maingon, MD||Centre Georges Francois Leclerc|
|OverallOfficial:||Franck Bonnetain, PhD||Centre Georges Francois Leclerc|