Study of Anxiety and Avoidance of Others in Patients Previously Treated for Head and Neck Cancer
NCT ID: NCT00483639
Last Updated: 2013-03-15
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
100 participants
OBSERVATIONAL
2003-11-30
2008-01-31
Brief Summary
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PURPOSE: This clinical trial is studying anxiety and avoidance of others in patients previously treated for head and neck cancer.
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Detailed Description
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* Determine the relationship between treatment-provoked social anxiety and avoidance in patients previously treated for head and neck cancer.
* Determine the relationship between pre-cancer psychiatric diagnosis and post-treatment social anxiety and avoidance in these patients.
* Determine the effect of social anxiety and/or avoidance on the quality of life of these patients.
* Investigate the specificity of these relationships in patients with head and neck cancer by comparing patients with head and neck cancer to patients with lung cancer.
OUTLINE: This is a cross-sectional study. Patients are stratified according to prior treatment type (significantly impairing \[surgery\] vs less impairing \[chemotherapy/radiotherapy\]).
Patients undergo a face-to-face interview with a mental health clinician over 2 hours. Patients complete multiple psychiatric/psychological assessments during the interview, including the Structured Clinical Interview for DSM-IV (SCID); the Liebowitz Social Anxiety Scale (SAS); the Performance Status Scale for Head and Neck Cancer Patients (PSS-HN); the Social Phobia and Anxiety Inventory (SPAI); the State-Trait Anxiety Inventory (STAI); Response to Stress Questionnaire, Cancer Version (RSQ-CV); the Functional Assessment of Cancer Therapy (FACT-HNC (head neck cancer) or LC); the Voice Handicap Index (VHI); and the Body Image Scale (BIS).
Cancer treatment and medical history information are gathered from patients' medical records.
Conditions
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Study Design
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CASE_CONTROL
PROSPECTIVE
Interventions
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Medical chart review
medical chart review
Liebowitz Social Anxiety Scale and the Social Phobia and Anxiety Inventory
survey administration
management of therapy complications
management of therapy complications
Structured Clinical Interview for the Diagnostic and Statistical Manual-IV SCID
psychosocial assessment
Functional Assessment of Cancer Therapy-General (FACT-G)
survey administration
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Diagnosis of 1 of the following:
* Head and neck cancer
* Lung cancer (control group)
* Must have received treatment for head and neck cancer or lung cancer within the past 5 years
PATIENT CHARACTERISTICS:
* Able to speak and read English to answer surveys, interviews, and questionnaires
PRIOR CONCURRENT THERAPY:
* See Disease Characteristics
21 Years
70 Years
ALL
No
Sponsors
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National Cancer Institute (NCI)
NIH
Vanderbilt-Ingram Cancer Center
OTHER
Responsible Party
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Kirsten Haman, PhD
Research Assistant Professor; Psychologist
Principal Investigators
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Kirsten Haman, PhD
Role: PRINCIPAL_INVESTIGATOR
Vanderbilt-Ingram Cancer Center
Locations
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MBCCOP - Meharry Medical College - Nashville
Nashville, Tennessee, United States
Vanderbilt-Ingram Cancer Center
Nashville, Tennessee, United States
Countries
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Other Identifiers
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VU-VICC-HN-0397
Identifier Type: -
Identifier Source: secondary_id
VU-VICC-IRB-030785
Identifier Type: -
Identifier Source: secondary_id
VICC HN 0397
Identifier Type: -
Identifier Source: org_study_id
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