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


N/A
21 Years
N/A
Not Enrolling
Both
Fatigue, Head and Neck Cancer, Psychosocial Effects of Cancer and Its Treatment, Sleep Disorders

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Trial Information

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


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.

Inclusion 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

Type of Study:

Observational

Study Design:

Observational Model: Cohort, Time Perspective: Prospective

Outcome Measure:

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

Outcome Description:

patient given survey while in hospital.

Outcome Time Frame:

in patient

Safety Issue:

No

Principal Investigator

Brittany Holmes

Investigator Role:

Principal Investigator

Investigator Affiliation:

Vanderbilt-Ingram Cancer Center

Authority:

United States: Federal Government

Study ID:

CDR0000583565

NCT ID:

NCT00616590

Start Date:

July 2007

Completion Date:

Related Keywords:

  • Fatigue
  • Head and Neck Cancer
  • Psychosocial Effects of Cancer and Its Treatment
  • Sleep Disorders
  • 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
  • stage IV adenoid cystic carcinoma of the oral cavity
  • stage IV mucoepidermoid carcinoma of the oral cavity
  • stage IV verrucous carcinoma of the oral cavity
  • stage I squamous cell carcinoma of the lip and oral cavity
  • stage II squamous cell carcinoma of the lip and oral cavity
  • stage III squamous cell carcinoma of the lip and oral cavity
  • stage IV squamous cell carcinoma of the lip and oral cavity
  • recurrent basal cell carcinoma of the lip
  • recurrent squamous cell carcinoma of the lip and oral cavity
  • stage I basal cell carcinoma of the lip
  • stage II basal cell carcinoma of the lip
  • stage III basal cell carcinoma of the lip
  • stage IV basal cell carcinoma of the lip
  • metastatic squamous neck cancer with occult primary squamous cell carcinoma
  • recurrent metastatic squamous neck cancer with occult primary
  • recurrent lymphoepithelioma of the nasopharynx
  • recurrent squamous cell carcinoma of the nasopharynx
  • stage I lymphoepithelioma of the nasopharynx
  • stage I squamous cell carcinoma of the nasopharynx
  • stage II lymphoepithelioma of the nasopharynx
  • stage II squamous cell carcinoma of the nasopharynx
  • stage III lymphoepithelioma of the nasopharynx
  • stage III squamous cell carcinoma of the nasopharynx
  • stage IV lymphoepithelioma of the nasopharynx
  • stage IV squamous cell carcinoma of the nasopharynx
  • recurrent lymphoepithelioma of the oropharynx
  • recurrent squamous cell carcinoma of the oropharynx
  • stage I lymphoepithelioma of the oropharynx
  • stage I squamous cell carcinoma of the oropharynx
  • stage II lymphoepithelioma of the oropharynx
  • stage II squamous cell carcinoma of the oropharynx
  • stage III lymphoepithelioma of the oropharynx
  • stage III squamous cell carcinoma of the oropharynx
  • stage IV lymphoepithelioma of the oropharynx
  • stage IV squamous cell carcinoma of the oropharynx
  • recurrent esthesioneuroblastoma of the paranasal sinus and nasal cavity
  • recurrent inverted papilloma of the paranasal sinus and nasal cavity
  • recurrent midline lethal granuloma of the paranasal sinus and nasal cavity
  • recurrent squamous cell carcinoma of the paranasal sinus and nasal cavity
  • stage I esthesioneuroblastoma of the paranasal sinus and nasal cavity
  • stage I inverted papilloma of the paranasal sinus and nasal cavity
  • stage I midline lethal granuloma of the paranasal sinus and nasal cavity
  • stage I squamous cell carcinoma of the paranasal sinus and nasal cavity
  • stage II esthesioneuroblastoma of the paranasal sinus and nasal cavity
  • stage II inverted papilloma of the paranasal sinus and nasal cavity
  • stage II midline lethal granuloma of the paranasal sinus and nasal cavity
  • stage II squamous cell carcinoma of the paranasal sinus and nasal cavity
  • stage III esthesioneuroblastoma of the paranasal sinus and nasal cavity
  • stage III inverted papilloma of the paranasal sinus and nasal cavity
  • stage III midline lethal granuloma of the paranasal sinus and nasal cavity
  • stage III squamous cell carcinoma of the paranasal sinus and nasal cavity
  • stage IV esthesioneuroblastoma of the paranasal sinus and nasal cavity
  • stage IV inverted papilloma of the paranasal sinus and nasal cavity
  • stage IV midline lethal granuloma of the paranasal sinus and nasal cavity
  • stage IV squamous cell carcinoma of the paranasal sinus and nasal cavity
  • recurrent salivary gland cancer
  • stage I salivary gland cancer
  • stage II salivary gland cancer
  • stage III salivary gland cancer
  • stage IV salivary gland cancer
  • Fatigue
  • Head and Neck Neoplasms
  • Sleep Disorders
  • Parasomnias

Name

Location

Vanderbilt-Ingram Cancer CenterNashville, Tennessee  37232-6838
Vanderbilt-Ingram Cancer Center - Cool SpringsNashville, Tennessee  37064
Vanderbilt-Ingram Cancer Center at FranklinNashville, Tennessee  37064