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

Head and Neck Cancer Clinical Trial

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

Clinical Trial 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.

Clinical Trial 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. ;

Study Design

N/A

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT01210872
Study type Observational
Source National Cancer Institute (NCI)
Contact
Status Recruiting
Phase N/A
Start date September 2009
View Details
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