NCT01210872

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

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

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 200 (estimated)
• Sponsor: Centre Georges Francois Leclerc · Academic / Other
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Head and Neck Cancer

Interventions

Type	Name	Description
OTHER	questionnaire administration
PROCEDURE	quality-of-life assessment
PROCEDURE	standard follow-up care

Timeline

• Start date: 2009-09-01
• Primary completion: 2013-09-01
• First posted: 2010-09-29
• Last updated: 2013-08-07

Locations

1 site across 1 country: France