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Insomnia in Patients Undergoing Chemotherapy and Radiation Therapy for Head and Neck Cancer - NCT00616590-37064A(Clinical Trial 202937)



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City:  Nashville
State:  
TN
Zip Code: 37064
Conditions: Fatigue - Head and Neck Cancer - Psychosocial Effects of Cancer and Its Treatment - Sleep Disorders
Purpose: RATIONALE: Learning about insomnia and quality of life in patients undergoing chemotherapy and radiation therapy for cancer may help doctors learn about the effects of treatment and plan the best treatment. PURPOSE: This clinical trial is studying insomnia in patients undergoing chemotherapy and radiation therapy for head and neck cancer.
Study summary: OBJECTIVES: - To assess the prevalence of insomnia, extent of sleep disturbance, and possible contributing factors to sleep disturbance in head and neck cancer patients undergoing chemoradiotherapy. - To evaluate the relationships between insomnia and symptom burden, quality of life, mood, fatigue, and tumor/treatment variables in these patients. OUTLINE: Patients complete a demographic survey and a questionnaire packet comprising The Pittsburgh Sleep Quality Index, The Head and Neck Symptom Survey, Profile of Mood States, Suspected Causes of Insomnia Survey, and a Quality of Life Survey on day 1 of chemoradiotherapy to obtain baseline data on sleep quality, possible causes of sleep disruption, head and neck symptoms, mood state, fatigue, quality of life, and patient demographics. Questionnaires are administered weekly thereafter during therapy visits for up to 6-7 weeks and take 15-30 minutes to complete. Medical records are reviewed to obtain information regarding medications and tumor- and treatment-related variables.
Criteria: DISEASE CHARACTERISTICS: - Diagnosis of head or neck carcinoma - Currently undergoing chemoradiotherapy PATIENT CHARACTERISTICS: - Able to communicate in English - Able to give informed consent PRIOR CONCURRENT THERAPY: - See Disease Characteristics
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Data Source: ClinicalTrials.gov
Date Processed: December 30, 2009
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