Quality-Of-Life Assessment in Patients With Head and Neck Cancer Treated With Radiation Therapy
Recruitment status was: Recruiting
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.
Head and Neck Cancer
Other: questionnaire administration
Procedure: quality-of-life assessment
Procedure: standard follow-up care
|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|
- Satisfaction of care (EORTC QLQ-SAT32) [ Designated as safety issue: No ]
- Quality of life (EORTC QLQ-C30 and specific module QLQ-H&N35/Euroqol EQ-5D) [ Designated as safety issue: No ]
- Toxicity (occurrence and length) according to NCI-CTC version 3.0 [ Designated as safety issue: Yes ]
- Overall survival [ Designated as safety issue: No ]
|Study Start Date:||September 2009|
|Estimated Primary Completion Date:||September 2013 (Final data collection date for primary outcome measure)|
- 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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01210872
|Centre de Lutte Contre le Cancer Georges-Francois Leclerc|
|Dijon, France, 21079|
|Study Chair:||Philippe Maingon, MD||Centre Georges Francois Leclerc|
|OverallOfficial:||Franck Bonnetain, PhD||Centre Georges Francois Leclerc|