Clinical trial NCT01210872: Quality-Of-Life Assessment in Patients With Head and Neck Cancer Treated With Radiation Therapy
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
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Head and Neck Cancer
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
Lead sponsor: National Cancer Institute (NCI)
Sponsor class: NIH
First posted: 2010-09-29
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no

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.

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

Primary outcomes:
measure: Satisfaction of care (EORTC QLQ-SAT32)
measure: Quality of life (EORTC QLQ-C30 and specific module QLQ-H&N35/Euroqol EQ-5D)
Secondary outcomes:
measure: Toxicity (occurrence and length) according to NCI-CTC version 3.0
measure: Overall survival
Other outcomes:
Locations:
city: Dijon
country: France
facility: Centre de Lutte Contre le Cancer Georges-Francois Leclerc
Study officials:
affiliation: Centre Georges Francois Leclerc
name: Philippe Maingon, MD
role: STUDY_CHAIR
affiliation: Centre Georges Francois Leclerc
name: Franck Bonnetain, PhD
References: