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

Centre Georges Francois Leclerc

Status: Unknown

Conditions: Head and Neck Cancer

Treatments: Other: questionnaire administration; Procedure: quality-of-life assessment; Procedure: standard follow-up care

Study type: Observational

Funder types: Other

Identifiers

NCT01210872

CGFL-QDV

CGFL-AFSSAPS-2008-A01468-47

CDR0000683850 (Registry Identifier)

EU-21061

Details and patient eligibility

About

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.

Full 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.

Enrollment: 200 estimated patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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