Assessment of Insomnia in Patients With Head and Neck Cancer During Treatment
| Registry | NCT00616590 |
|---|---|
| Status | Withdrawn |
| Study type | Observational |
| Sponsor | Vanderbilt University (Other); collaborators: National Cancer Institute (NCI) |
| Conditions | Fatigue, Head and Neck Cancer, Psychosocial Effects of Cancer and Its Treatment, Sleep Disorders |
| Interventions | medical chart review, questionnaire administration, fatigue assessment and management, quality-of-life assessment (Other, procedure) |
| Dates | start 2007-07-01, primary completion 2012-07-01 (estimated), first posted 2008-02-15, last updated 2014-06-17 |
| Locations | 3 sites in United States |
Related Papers Related Patents Related Grants Related Experts
All trials for Fatigue All trials for Head and Neck Cancer All trials of medical chart review All trials of questionnaire administration
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.
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.
Sex: All, ages: 21 Years to any
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
| Facility | City | Country | Status |
|---|---|---|---|
| Vanderbilt-Ingram Cancer Center - Cool Springs | Nashville, Tennessee | United States | |
| Vanderbilt-Ingram Cancer Center at Franklin | Nashville, Tennessee | United States | |
| Vanderbilt-Ingram Cancer Center | Nashville, Tennessee | United States |
NIH grants: P30CA068485