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

Study Overview
=================
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.

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

Conditions
-----------------
Head and Neck Cancer

Intervention / Treatment
-----------------
* Other: questionnaire administration
* Procedure: quality-of-life assessment
* Procedure: standard follow-up care


Participation Criteria
=================
Eligibility Criteria
-----------------
DISEASE CHARACTERISTICS: Diagnosis of primary nonmetastatic head and neck cancer No other primary cancer localizations No second tumor localization at the time of diagnosis Must be planning to be treated initially with radiotherapy PATIENT CHARACTERISTICS: No cognitive impairment or psychiatric history No history of other cancer PRIOR CONCURRENT THERAPY: No prior chemotherapy or radiotherapy

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Arms and Interventions

| Intervention/Treatment |
| --- |
|Other: questionnaire administration|nan|
|Procedure: quality-of-life assessment|nan|
|Procedure: standard follow-up care|nan|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Satisfaction of care (EORTC QLQ-SAT32) |  |  | 
| Quality of life (EORTC QLQ-C30 and specific module QLQ-H&N35/Euroqol EQ-5D) |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Toxicity (occurrence and length) according to NCI-CTC version 3.0 |  |  | 
| Overall survival |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
stage I squamous cell carcinoma of the lip and oral cavity, stage II squamous cell carcinoma of the lip and oral cavity, stage III squamous cell carcinoma of the lip and oral cavity, stage I lymphoepithelioma of the oropharynx, stage II lymphoepithelioma of the oropharynx, stage III lymphoepithelioma of the oropharynx, stage I squamous cell carcinoma of the oropharynx, stage II squamous cell carcinoma of the oropharynx, stage III squamous cell carcinoma of the oropharynx, stage I lymphoepithelioma of the nasopharynx, stage II lymphoepithelioma of the nasopharynx, stage III lymphoepithelioma of the nasopharynx, stage I squamous cell carcinoma of the nasopharynx, stage II squamous cell carcinoma of the nasopharynx, stage III squamous cell carcinoma of the nasopharynx, stage I squamous cell carcinoma of the hypopharynx, stage II squamous cell carcinoma of the hypopharynx, stage III squamous cell carcinoma of the hypopharynx, stage I squamous cell carcinoma of the larynx, stage II squamous cell carcinoma of the larynx, stage III squamous cell carcinoma of the larynx, stage I verrucous carcinoma of the larynx, stage II verrucous carcinoma of the larynx, stage III verrucous carcinoma of the larynx, tongue cancer