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Tracking Information | |||||
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First Received Date † | June 6, 2007 | ||||
Last Updated Date | May 9, 2009 | ||||
Start Date † | November 2003 | ||||
Current Primary Outcome Measures † |
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Original Primary Outcome Measures † | Same as current | ||||
Change History | Complete list of historical versions of study NCT00483639 on ClinicalTrials.gov Archive Site | ||||
Current Secondary Outcome Measures † | |||||
Original Secondary Outcome Measures † | |||||
Descriptive Information | |||||
Brief Title † | Study of Anxiety and Avoidance of Others in Patients Previously Treated for Head and Neck Cancer | ||||
Official Title † | Social Anxiety and Avoidance in Head and Neck Cancer Patients | ||||
Brief Summary | RATIONALE: Patients who undergo treatment for head and neck cancer may become anxious and avoid contact with other people. Learning how cancer treatment may cause anxiety in patients with head and neck cancer may help improve the quality of life in these patients. 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 | OBJECTIVES:
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 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. |
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Study Phase | |||||
Study Type † | Interventional | ||||
Study Design † | Other | ||||
Condition † |
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Intervention † |
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Study Arms / Comparison Groups | |||||
Publications * | |||||
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline. |
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Recruitment Information | |||||
Recruitment Status † | Suspended | ||||
Estimated Enrollment † | 400 | ||||
Completion Date | |||||
Estimated Primary Completion Date | November 2012 (final data collection date for primary outcome measure) | ||||
Eligibility Criteria † | DISEASE CHARACTERISTICS:
PATIENT CHARACTERISTICS:
PRIOR CONCURRENT THERAPY:
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Gender | Both | ||||
Ages | 21 Years to 70 Years | ||||
Accepts Healthy Volunteers | No | ||||
Contacts †† | |||||
Location Countries † | United States | ||||
Expanded Access Status | |||||
Administrative Information | |||||
NCT ID † | NCT00483639 | ||||
Responsible Party | |||||
Secondary IDs †† | VU-VICC-HN-0397, VU-VICC-IRB-030785 | ||||
Study Sponsor † | Vanderbilt-Ingram Cancer Center | ||||
Collaborators †† | National Cancer Institute (NCI) | ||||
Investigators † |
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Information Provided By | National Cancer Institute (NCI) | ||||
Verification Date | October 2008 | ||||
† Required WHO trial registration data element. †† WHO trial registration data element that is required only if it exists. |