Spots Global Cancer Trial Database for Quality-Of-Life Assessment in Patients With Head and Neck Cancer Treated With Radiation Therapy

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Trial Identification

Brief Title: Quality-Of-Life Assessment in Patients With Head and Neck Cancer Treated With Radiation Therapy

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 ID: NCT01210872

Conditions

Head and Neck Cancer

Interventions

questionnaire administration

quality-of-life assessment

standard follow-up care

Study Description

Brief Summary: 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.

Detailed Description: 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.