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

NCT00616590 — Withdrawn, Vanderbilt University

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Assessment of Insomnia in Patients With Head and Neck Cancer During Treatment

RegistryNCT00616590
StatusWithdrawn
Study typeObservational
SponsorVanderbilt University (Other); collaborators: National Cancer Institute (NCI)
ConditionsFatigue, Head and Neck Cancer, Psychosocial Effects of Cancer and Its Treatment, Sleep Disorders
Interventionsmedical chart review, questionnaire administration, fatigue assessment and management, quality-of-life assessment (Other, procedure)
Datesstart 2007-07-01, primary completion 2012-07-01 (estimated), first posted 2008-02-15, last updated 2014-06-17
Locations3 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

-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.

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+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.

+Arms and interventions

  • medical chart review (Other)
  • questionnaire administration (Other)
  • fatigue assessment and management (Procedure)
  • quality-of-life assessment (Procedure)

+Outcome measures

Primary outcomes

  • Relationships between insomnia and symptom burden, quality of life, mood, fatigue, and tumor/treatment variables as assessed by general demographics, The Head and Neck Symptom Survey, Quality of Life Survey, and Profile of Mood States [in patient]: patient given survey while in hospital.

+Eligibility

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

+Locations (3)

FacilityCityCountryStatus
Vanderbilt-Ingram Cancer Center - Cool SpringsNashville, TennesseeUnited States
Vanderbilt-Ingram Cancer Center at FranklinNashville, TennesseeUnited States
Vanderbilt-Ingram Cancer CenterNashville, TennesseeUnited States

+Investigators

+Funding

NIH grants: P30CA068485