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
OBJECTIVES:
Primary
- 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.
Secondary
- 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.
Observational
N/A
Satisfaction of care (EORTC QLQ-SAT32)
No
Philippe Maingon, MD
Study Chair
Centre de Lutte Contre le Cancer Georges-Francois Leclerc
Unspecified
CDR0000683850
NCT01210872
September 2009
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