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Study of Anxiety and Avoidance of Others in Patients Previously Treated for Head and Neck Cancer
This study has been suspended.
Study NCT00483639   Information provided by National Cancer Institute (NCI)
First Received: June 6, 2007   Last Updated: May 9, 2009   History of Changes
This Tabular View shows the required WHO registration data elements as marked by

June 6, 2007
May 9, 2009
November 2003
  • Relationship between treatment-provoked social anxiety and avoidance [ Designated as safety issue: No ]
  • Relationship between pre-cancer psychiatric diagnosis and post-treatment social anxiety and avoidance [ Designated as safety issue: No ]
  • Quality of life [ Designated as safety issue: No ]
  • Comparison of social anxiety and avoidance in patients with head and neck cancer to patients with lung cancer [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00483639 on ClinicalTrials.gov Archive Site
 
 
 
Study of Anxiety and Avoidance of Others in Patients Previously Treated for Head and Neck Cancer
Social Anxiety and Avoidance in Head and Neck Cancer Patients

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.

OBJECTIVES:

  • 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 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.

 
Interventional
Other
  • Anxiety Disorder
  • Head and Neck Cancer
  • Long-Term Effects Secondary to Cancer Therapy in Adults
  • Lung Cancer
  • Other: medical chart review
  • Other: questionnaire administration
  • Other: survey administration
  • Procedure: management of therapy complications
  • Procedure: psychosocial assessment and care
 
 

*   Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
 
Suspended
400
 
November 2012   (final data collection date for primary outcome measure)

DISEASE CHARACTERISTICS:

  • 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
Both
21 Years to 70 Years
No
 
United States
 
 
NCT00483639
 
VU-VICC-HN-0397, VU-VICC-IRB-030785
Vanderbilt-Ingram Cancer Center
National Cancer Institute (NCI)
Study Chair: Kirsten Haman, PhD Vanderbilt-Ingram Cancer Center
National Cancer Institute (NCI)
October 2008

 †    Required WHO trial registration data element.
††   WHO trial registration data element that is required only if it exists.