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Insomnia in Patients Undergoing Chemotherapy and Radiation Therapy for Head and Neck Cancer

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Vanderbilt University

Status

Withdrawn

Conditions

Sleep Disorders
Psychosocial Effects of Cancer and Its Treatment
Head and Neck Cancer
Fatigue

Treatments

Procedure: quality-of-life assessment
Other: questionnaire administration
Procedure: fatigue assessment and management
Other: medical chart review

Study type

Observational

Funder types

Other
NIH

Identifiers

NCT00616590
P30CA068485 (U.S. NIH Grant/Contract)
CDR0000583565
VU-VICC-SUPP-0742

Details and patient eligibility

About

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.

Full 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.

Sex

All

Ages

21+ years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion 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

Trial contacts and locations

3

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Data sourced from clinicaltrials.gov

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