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

• Conditions: Head and Neck Cancer

• Registration Number: NCT01210872
• Lead Sponsor: Centre Georges Francois Leclerc

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.

Study Timeline

• Study Start: 2009-09
• Status Verified: 2010-09
• Study First Submitted: 2010-09-28
• Study First Submitted QC: 2010-09-28
• Study First Posted: 2010-09-29
• Last Update Submitted: 2013-08-06
• Last Update Posted: 2013-08-07
• Primary Completion: 2013-09

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 200

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Satisfaction of care (EORTC QLQ-SAT32)
Quality of life (EORTC QLQ-C30 and specific module QLQ-H&N35/Euroqol EQ-5D)

Secondary Outcome Measures

Name	Time	Method
Toxicity (occurrence and length) according to NCI-CTC version 3.0
Overall survival

Trial Locations

Locations (1)

Centre de Lutte Contre le Cancer Georges-Francois Leclerc; 🇫🇷 Dijon, France