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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

200 participants

Study Classification

OBSERVATIONAL

Study Start Date

2009-09-30

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Head and Neck Cancer

Interventions

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questionnaire administration

Intervention Type OTHER

quality-of-life assessment

Intervention Type PROCEDURE

standard follow-up care

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion 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

Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No