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

This study has been terminated.
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by:
Vanderbilt University
ClinicalTrials.gov Identifier:
NCT00616590
First received: February 14, 2008
Last updated: March 22, 2011
Last verified: March 2011
History of Changes
  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.


Condition Intervention
Fatigue
Head and Neck Cancer
Psychosocial Effects of Cancer and Its Treatment
Sleep Disorders
 Other: medical chart review
Other: questionnaire administration
Procedure: fatigue assessment and management
Procedure: quality-of-life assessment

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Assessment of Insomnia in Patients With Head and Neck Cancer During Treatment

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Vanderbilt University:

Primary Outcome Measures:
  • 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 [ Time Frame: in patient ] [ Designated as safety issue: No ]
    patient given survey while in hospital.


Estimated Enrollment: 50
Study Start Date: July 2007
Estimated Primary Completion Date: July 2012 (Final data collection date for primary outcome measure)
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.

  Eligibility

Ages Eligible for Study:   21 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

cancer patients

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00616590

Locations
United States, Tennessee
Vanderbilt-Ingram Cancer Center - Cool Springs
Nashville, Tennessee, United States, 37064
Vanderbilt-Ingram Cancer Center at Franklin
Nashville, Tennessee, United States, 37064
Vanderbilt-Ingram Cancer Center
Nashville, Tennessee, United States, 37232-6838
Sponsors and Collaborators
Vanderbilt University
National Cancer Institute (NCI)
Investigators
Principal Investigator: Brittany Holmes Vanderbilt-Ingram Cancer Center
  More Information

No publications provided

Responsible Party: Brittnay Holmes, vanderbilt
ClinicalTrials.gov Identifier: NCT00616590     History of Changes
Other Study ID Numbers: CDR0000583565, P30CA068485, VU-VICC-SUPP-0742
Study First Received: February 14, 2008
Last Updated: March 22, 2011
Health Authority: United States: Federal Government

Keywords provided by Vanderbilt University:
sleep disorders
psychosocial effects of cancer and its treatment
fatigue
recurrent squamous cell carcinoma of the hypopharynx
stage I squamous cell carcinoma of the hypopharynx
stage II squamous cell carcinoma of the hypopharynx
stage III squamous cell carcinoma of the hypopharynx
stage IV squamous cell carcinoma of the hypopharynx
recurrent squamous cell carcinoma of the larynx
recurrent verrucous carcinoma of the larynx
stage I squamous cell carcinoma of the larynx
stage I verrucous carcinoma of the larynx
stage II squamous cell carcinoma of the larynx
stage II verrucous carcinoma of the larynx
stage III squamous cell carcinoma of the larynx
 stage III verrucous carcinoma of the larynx
stage IV squamous cell carcinoma of the larynx
stage IV verrucous carcinoma of the larynx
recurrent adenoid cystic carcinoma of the oral cavity
recurrent mucoepidermoid carcinoma of the oral cavity
recurrent verrucous carcinoma of the oral cavity
stage I adenoid cystic carcinoma of the oral cavity
stage I mucoepidermoid carcinoma of the oral cavity
stage I verrucous carcinoma of the oral cavity
stage II adenoid cystic carcinoma of the oral cavity
stage II mucoepidermoid carcinoma of the oral cavity
stage II verrucous carcinoma of the oral cavity
stage III adenoid cystic carcinoma of the oral cavity
stage III mucoepidermoid carcinoma of the oral cavity
stage III verrucous carcinoma of the oral cavity

Additional relevant MeSH terms:
Fatigue
Head and Neck Neoplasms
Sleep Disorders
Parasomnias
Signs and Symptoms
 Neoplasms by Site
Neoplasms
Nervous System Diseases
Neurologic Manifestations
Mental Disorders

ClinicalTrials.gov processed this record on May 22, 2013