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NCT00616590 Clinical Trial

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

Head and Neck Cancer Clinical Trial

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

Clinical Trial Details — Status: Withdrawn

Administrative data
NCT number NCT00616590
Other study ID # CDR0000583565
Secondary ID P30CA068485VU-VI
Status Withdrawn
Phase N/A
First received February 14, 2008
Last updated June 15, 2014
Start date July 2007

Study information
Verified date June 2014
Source Vanderbilt University
Contact n/a
Is FDA regulated No
Health authority United States: Federal Government
Study type Observational

Clinical Trial 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.

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.

Recruitment information / eligibility
Status Withdrawn
Enrollment 0
Est. completion date
Est. primary completion date July 2012
Accepts healthy volunteers No
Gender Both
Age group 21 Years and older
Eligibility 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

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

Intervention

Other:
• medical chart review

• questionnaire administration

Procedure:
• fatigue assessment and management

• quality-of-life assessment

Locations
Country Name City State
United States Vanderbilt-Ingram Cancer Center Nashville Tennessee
United States Vanderbilt-Ingram Cancer Center - Cool Springs Nashville Tennessee
United States Vanderbilt-Ingram Cancer Center at Franklin Nashville Tennessee

Sponsors (2)
Lead Sponsor Collaborator
Vanderbilt University National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary 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 No
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