Trials / Withdrawn
WithdrawnNCT00616590
Insomnia in Patients Undergoing Chemotherapy and Radiation Therapy for Head and Neck Cancer
Assessment of Insomnia in Patients With Head and Neck Cancer During Treatment
- Status
- Withdrawn
- Phase
- —
- Study type
- Observational
- Enrollment
- 0 (actual)
- Sponsor
- Vanderbilt University · Academic / Other
- Sex
- All
- Age
- 21 Years
- Healthy volunteers
- Not accepted
Summary
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.
Detailed description
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| OTHER | medical chart review | |
| OTHER | questionnaire administration | |
| PROCEDURE | fatigue assessment and management | |
| PROCEDURE | quality-of-life assessment |
Timeline
- Start date
- 2007-07-01
- Primary completion
- 2012-07-01
- First posted
- 2008-02-15
- Last updated
- 2014-06-17
Locations
3 sites across 1 country: United States
Source: ClinicalTrials.gov record NCT00616590. Inclusion in this directory is not an endorsement.