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.

Study Overview

• Status: Completed
• Conditions: Head and Neck Cancer; Lung Cancer; Anxiety Disorder
• Intervention / Treatment: Other: Medical chart review; Other: Liebowitz Social Anxiety Scale and the Social Phobia and Anxiety Inventory; Procedure: management of therapy complications; Procedure: Structured Clinical Interview for the Diagnostic and Statistical Manual-IV SCID; Other: Functional Assessment of Cancer Therapy-General (FACT-G)

Detailed 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 Type: Observational
• Enrollment (Actual): 100

Contacts and Locations

Study Locations

• United States
  • Tennessee
    • Nashville, Tennessee, United States, 37208
      • MBCCOP - Meharry Medical College - Nashville
    • Nashville, Tennessee, United States, 37232-6838
      • Vanderbilt-Ingram Cancer Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 21 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

People who have been treated for head and neck cancer.

Description

PATIENT 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

Study Plan

How is the study designed?

Design Details

• Observational Models: Case-Control
• Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Level of social anxiety and avoidance in HNC patients post-treatment	Measured by the Liebowitz Social Anxiety Scale and the Social Phobia and Anxiety Inventory, containing 24 items with each item separately rated for fear as 0 (none), 1 (mild), 2 (moderate) to 3 (severe)and for avoidance behavior as 0 (never), 1 (occasionally), 2 (often), to 3 (usually). Scores are summed with lower values indicating lower levels of social anxiety and avoidance.	at study entry, day 1

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Relationship between pre-cancer psychiatric diagnosis and post-treatment social anxiety and avoidance	Assessed using the Structured Clinical Interview for the Diagnostic and Statistical Manual-IV SCID lifetime diagnostic status (pre-cancer diagnosis) and related to the outcome for social anxiety measures. The SCID does not involve a specific scoring of responses. Trained interviewers ask questions that may involve yes/no answers or more detailed explanations. They make their diagnoses based on their experience and training. For this outcome, interviews results will be compared to and contrasted with scores on the Liebowitz Social Anxiety Scale and Social Phobia and Anxiety Inventory.	at study entry
Quality of Life	Each patient is scored on the Functional Assessment of Cancer Therapy-General (FACT-G) with 4 related sub-scales (physical, social/family, emotional, functional well-being. To generate sub-scale scores, physical and emotional items are reverse coded and items are then summed, such that higher values indicate better quality of life. Thus, each sub-scale score ranges from 0 (not at all, worse outcome) to 4 (very much, better outcome) with a minimum total score of 0 (worst quality of life) to a maximum of 16 (good quality of life).	at study entry, day 1
Comparison of social anxiety and avoidance in patients with head and neck cancer to patients with lung cancer	Measured by the Liebowitz Social Anxiety Scale and the Social Phobia and Anxiety Inventory, containing 24 items with each item separately rated for fear as 0 (none), 1 (mild), 2 (moderate) to 3 (severe)and for avoidance behavior as 0 (never), 1 (occasionally), 2 (often), to 3 (usually). Scores are summed with lower values indicating lower levels of social anxiety and avoidance. Scores in study participants will be compared to scores in studies of social anxiety and avoidance in lung cancer patients	at study entry, day 1

Collaborators and Investigators

• Sponsor: Vanderbilt-Ingram Cancer Center
• Collaborators: National Cancer Institute (NCI)
• Investigators: Principal Investigator: Kirsten Haman, PhD, Vanderbilt-Ingram Cancer Center

Study record dates

Study Major Dates

• Study Start: November 1, 2003
• Primary Completion (Actual): March 1, 2006
• Study Completion (Actual): January 1, 2008

Study Registration Dates

• First Submitted: June 6, 2007
• First Submitted That Met QC Criteria: June 6, 2007
• First Posted (Estimate): June 7, 2007

Study Record Updates

• Last Update Posted (Estimate): March 15, 2013
• Last Update Submitted That Met QC Criteria: March 13, 2013
• Last Verified: March 1, 2013

More Information

Terms related to this study

• Keywords: non-small cell lung cancer; anxiety disorder; head and neck cancer; long-term effects secondary to cancer therapy in adults; small cell lung cancer
• Additional Relevant MeSH Terms: Mental Disorders; Respiratory Tract Diseases; Neoplasms; Lung Diseases; Neoplasms by Site; Respiratory Tract Neoplasms; Thoracic Neoplasms; Head and Neck Neoplasms; Lung Neoplasms; Anxiety Disorders
• Other Study ID Numbers: VICC HN 0397; VU-VICC-HN-0397; VU-VICC-IRB-030785

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No