Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

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

June 6, 2007
March 13, 2013
November 2003
March 2006   (final data collection date for primary outcome measure)
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.
Not Provided
Complete list of historical versions of study NCT00483639 on ClinicalTrials.gov Archive Site
  • 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
Not Provided
Not Provided
Not Provided
 
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 (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.

Observational
Observational Model: Case Control
Time Perspective: Prospective
Not Provided
Not Provided
Probability Sample

People who have been treated for head and neck cancer.

  • Anxiety Disorder
  • Head and Neck Cancer
  • Lung Cancer
  • 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
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
100
January 2008
March 2006   (final data collection date for primary outcome measure)

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
Both
21 Years to 70 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00483639
VICC HN 0397, VU-VICC-HN-0397, VU-VICC-IRB-030785
Yes
Kirsten Haman, PhD, Vanderbilt-Ingram Cancer Center
Vanderbilt-Ingram Cancer Center
National Cancer Institute (NCI)
Principal Investigator: Kirsten Haman, PhD Vanderbilt-Ingram Cancer Center
Vanderbilt-Ingram Cancer Center
March 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP