Insomnia in Patients Undergoing Chemotherapy and Radiation Therapy for Head and Neck Cancer - Full Text View

Sponsors and Collaborators:	Vanderbilt-Ingram Cancer Center National Cancer Institute (NCI)
Information provided by:	National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:	NCT00616590

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

Resource links provided by NLM:

MedlinePlus related topics: Cancer Head and Neck Cancer Radiation Therapy Salivary Gland Disorders Sleep Disorders Tonsils and Adenoids

U.S. FDA Resources

Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:

Prevalence of insomnia, extent of sleep disturbance, and the possible contributing factors to sleep disturbance as assessed by the Pittsburgh Sleep Quality Index and the Suspected Causes of Insomnia Survey [ Designated as safety issue: No ]
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 [ Designated as safety issue: No ]

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

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	Recruiting
Nashville, Tennessee, United States, 37064
Contact: Brittany Holmes 615-322-4967
Vanderbilt-Ingram Cancer Center at Franklin	Recruiting
Nashville, Tennessee, United States, 37064
Contact: Brittany Holmes 615-591-9890
Vanderbilt-Ingram Cancer Center	Recruiting
Nashville, Tennessee, United States, 37232-6838
Contact: Clinical Trials Office - Vanderbilt-Ingram Cancer Center 800-811-8480

Sponsors and Collaborators

Vanderbilt-Ingram Cancer Center

National Cancer Institute (NCI)

Investigators

Principal Investigator:

Brittany Holmes

Vanderbilt-Ingram Cancer Center

More Information

Additional Information:

Clinical trial summary from the National Cancer Institute's PDQ® database This link exits the ClinicalTrials.gov site

No publications provided

Study ID Numbers:	CDR0000583565, VU-VICC-SUPP-0742
Study First Received:	February 14, 2008
Last Updated:	August 11, 2009
ClinicalTrials.gov Identifier:	NCT00616590 History of Changes
Health Authority:	Unspecified

Keywords provided by National Cancer Institute (NCI):

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

Study placed in the following topic categories:

Nasopharyngeal Carcinoma
Fatigue
Laryngeal Carcinoma
Sleep Disorders
Carcinoma, Basal Cell
Squamous Cell Carcinoma
Granuloma
Recurrence
Hypopharyngeal Cancer
Carcinoma
Signs and Symptoms

Metastatic Squamous Neck Cancer With Occult Primary
Carcinoma, Adenoid Cystic
Mental Disorders
Head and Neck Neoplasms
Epidermoid Carcinoma
Neurologic Manifestations
Adenoid Cystic Carcinoma
Carcinoma, Squamous Cell
Papilloma
Salivary Gland Diseases

Additional relevant MeSH terms:

Signs and Symptoms
Neoplasms
Neoplasms by Site
Fatigue
Mental Disorders

Head and Neck Neoplasms
Nervous System Diseases
Neurologic Manifestations
Sleep Disorders

ClinicalTrials.gov processed this record on September 10, 2009