Quality-Of-Life Assessment in Patients With Head and Neck Cancer Treated With Radiation Therapy
Conditions
Head and Neck Cancer
Conditions: official terms
Head and Neck Neoplasms
Conditions: Keywords
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
Study Type
Observational
Study Phase
N/A
Study Design
N/A
Intervention
Name: questionnaire administration Type: Other
Name: quality-of-life assessment Type: Procedure
Name: standard follow-up care Type: Procedure
Overall Status
Recruiting
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.
Criteria for eligibility
Healthy Volunteers: No
Maximum Age: 70 Years
Minimum Age: 18 Years
Gender: Both
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
Location
Centre de Lutte Contre le Cancer Georges-Francois Leclerc
Dijon, France
Status: Recruiting
Contact: Contact Person - 33-3-8073-7784 - pmaingon@dijon.fnclcc.fr
Start Date
September 2009
Sponsors
Centre de Lutte Contre le Cancer Georges-Francois Leclerc
Source
National Cancer Institute (NCI)
Record processing date
ClinicalTrials.gov processed this data on July 28, 2015
ClinicalTrials.gov page