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

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Kirsten Haman, PhD, Vanderbilt-Ingram Cancer Center
ClinicalTrials.gov Identifier:
NCT00483639
First received: June 6, 2007
Last updated: March 13, 2013
Last verified: March 2013
  Purpose

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.


Condition Intervention
Anxiety Disorder
Head and Neck Cancer
Lung Cancer
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)

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Prospective
Official Title: Social Anxiety and Avoidance in Head and Neck Cancer Patients

Resource links provided by NLM:


Further study details as provided by Vanderbilt-Ingram Cancer Center:

Primary Outcome Measures:
  • Level of social anxiety and avoidance in HNC patients post-treatment [ Time Frame: at study entry, day 1 ] [ Designated as safety issue: No ]
    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.


Secondary Outcome Measures:
  • Relationship between pre-cancer psychiatric diagnosis and post-treatment social anxiety and avoidance [ Time Frame: at study entry ] [ Designated as safety issue: No ]
    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.

  • Quality of Life [ Time Frame: at study entry, day 1 ] [ Designated as safety issue: No ]
    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).

  • Comparison of social anxiety and avoidance in patients with head and neck cancer to patients with lung cancer [ Time Frame: at study entry, day 1 ] [ Designated as safety issue: No ]
    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


Enrollment: 100
Study Start Date: November 2003
Study Completion Date: January 2008
Primary Completion Date: March 2006 (Final data collection date for primary outcome measure)
Intervention Details:
    Other: Medical chart review
    medical chart review
    Other: Liebowitz Social Anxiety Scale and the Social Phobia and Anxiety Inventory
    survey administration
    Other Name: survey administration
    Procedure: management of therapy complications
    management of therapy complications
    Other Name: management of therapy complications
    Procedure: Structured Clinical Interview for the Diagnostic and Statistical Manual-IV SCID
    psychosocial assessment
    Other Name: psychosocial assessment
    Other: Functional Assessment of Cancer Therapy-General (FACT-G)
    survey administration
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.

  Eligibility

Ages Eligible for Study:   21 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

People who have been treated for head and neck cancer.

Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00483639

Locations
United States, Tennessee
MBCCOP - Meharry Medical College - Nashville
Nashville, Tennessee, United States, 37208
Vanderbilt-Ingram Cancer Center
Nashville, Tennessee, United States, 37232-6838
Sponsors and Collaborators
Vanderbilt-Ingram Cancer Center
Investigators
Principal Investigator: Kirsten Haman, PhD Vanderbilt-Ingram Cancer Center
  More Information

No publications provided

Responsible Party: Kirsten Haman, PhD, Research Assistant Professor; Psychologist, Vanderbilt-Ingram Cancer Center
ClinicalTrials.gov Identifier: NCT00483639     History of Changes
Other Study ID Numbers: VICC HN 0397, VU-VICC-HN-0397, VU-VICC-IRB-030785
Study First Received: June 6, 2007
Last Updated: March 13, 2013
Health Authority: United States: Federal Government

Keywords provided by Vanderbilt-Ingram Cancer Center:
anxiety disorder
long-term effects secondary to cancer therapy in adults
head and neck cancer
non-small cell lung cancer
small cell lung cancer

Additional relevant MeSH terms:
Anxiety Disorders
Head and Neck Neoplasms
Lung Neoplasms
Lung Diseases
Mental Disorders
Neoplasms
Neoplasms by Site
Respiratory Tract Diseases
Respiratory Tract Neoplasms
Thoracic Neoplasms

ClinicalTrials.gov processed this record on October 20, 2014