Study of Anxiety & Avoidance of Others in Patients Previously Treated for

Status Completed

Clinical Trial 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.

Clinical Trial Description

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 (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. ;

Study Design

Observational Model: Case Control, Time Perspective: Prospective

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT00483639
Study type	Observational
Source	Vanderbilt-Ingram Cancer Center
Contact
Status	Completed
Phase	N/A
Start date	November 2003
Completion date	January 2008

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Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

Study of Anxiety and Avoidance of Others in Patients Previously Treated for Head and Neck Cancer

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms