Insomnia in Patients Undergoing Chemotherapy and Radiation Therapy for Head and Neck Cancer
Official Title
Assessment of Insomnia in Patients With Head and Neck Cancer During Treatment
Acronym
Not provided
Organization
Vanderbilt UniversityOTHER
Status Module
Record Verification Date
Jun 2014
Overall Recruitment Status or Expanded Access Status
Withdrawn
Last Known Status
Not provided
Delayed Posting
Not provided
Why Stopped
Not provided
Expanded Access Info
No
Start Date
Jul 2007
Primary Completion Date
Jul 2012Estimated
Completion Date
Not provided
First Submitted Date
Feb 14, 2008
First Submission Date that Met QC Criteria
Feb 14, 2008
First Posted Date
Feb 15, 2008Estimated
Results Waived
Not provided
Results First Submitted Date
Not provided
Results First Submitted that Met QC Criteria
Not provided
Results First Posted Date
Not provided
Certification/Extension (aka Delayed Results) First Submitted Date
Not provided
Certification/Extension First Submitted that Passed QC Review
Not provided
Certification/Extension First Posted Date
Not provided
Last Update Submitted Date
Jun 15, 2014
Last Update Posted Date
Jun 17, 2014Estimated
Sponsor/Collaborators Module
Responsible Party, by Official Title
Brittany Holmes, Medical Student, Vanderbilt UniversityPrincipal Investigator
Lead Sponsor
Vanderbilt UniversityOTHER
Collaborators
Name
Class
National Cancer Institute (NCI)
NIH
Oversight Module
No data available
No data is available for this block.
Description Module
Brief 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.
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.
Conditions Module
Conditions
Fatigue
Head and Neck Cancer
Psychosocial Effects of Cancer and Its Treatment
Sleep Disorders
Keywords
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
Design Module
Study Type
Observational
Number of References to an Expanded Access Study
Not provided
Expanded Access Types
Not provided
Patient Registry
Not provided
Target Follow-Up Duration
Not provided
Phases
Not provided
Interventional Study Design
Allocation
Not provided
Intervention Model
Biospecimen
No data available
No data is available for this block.
Enrollment
0Actual
Arms/Interventions Module
Arm Groups
Not provided
Interventions
Name
Type
Description
Arm Group Labels
Other Names
medical chart review
Other
questionnaire administration
Other
fatigue assessment and management
Procedure
quality-of-life assessment
Procedure
Outcomes Module
Primary Outcomes
Measure
Description
Time Frame
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
patient given survey while in hospital.
in patient
Secondary Outcomes
Not provided
Other Outcomes
Not provided
Eligibility Module
Eligibility 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
Accepts Healthy Volunteers
No
Sex
All
Sex/Gender Based
Not provided
Sex/Gender Description
Not provided
Minimum Age
21 Years
Maximum Age
Not provided
Standard Ages
AdultOlder Adult
Study Population
cancer patients
Sampling Method
Probability Sample
Contacts/Locations Module
Central Contacts
Not provided
Overall Officials
Name
Affiliation
Role
Brittany Holmes
Vanderbilt-Ingram Cancer Center
Principal Investigator
Locations
Facility
Status
City
State
ZIP
Country
Contacts
Vanderbilt-Ingram Cancer Center - Cool Springs
Nashville
Tennessee
37064
United States
Vanderbilt-Ingram Cancer Center at Franklin
References Module
No data available
No data is available for this block.
IPD Sharing Statement Module
No data available
No data is available for this block.
Results Section
No data available
No data is available for this block.
Annotation Section
No data available
No data is available for this block.
Document Section
No data available
No data is available for this block.
Derived Section
Miscellaneous Info Module
Version Holder
Jul 10, 2026
Removed Countries
Not provided
Submission Tracking
No data available
No data is available for this block.
Condition Browse Module
MeSH Terms
Intervention Browse Module
MeSH Terms
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