Clinical trial NCT00483639: Study of Anxiety and Avoidance of Others in Patients Previously Treated for Head and Neck Cancer
Official title: Social Anxiety and Avoidance in Head and Neck Cancer Patients
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Anxiety Disorder
Head and Neck Cancer
Lung Cancer
Keywords: anxiety disorder
long-term effects secondary to cancer therapy in adults
head and neck cancer
non-small cell lung cancer
small cell lung cancer
Lead sponsor: Vanderbilt-Ingram Cancer Center
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2007-06-07
Enrollment: 100
Sex: ALL
Minimum age (years): 21
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: People who have been treated for head and neck cancer.

Brief 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.

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 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

Primary outcomes:
measure: Level of social anxiety and avoidance in HNC patients post-treatment
timeFrame: at study entry, day 1
Secondary outcomes:
measure: Relationship between pre-cancer psychiatric diagnosis and post-treatment social anxiety and avoidance
timeFrame: at study entry
measure: Quality of Life
timeFrame: at study entry, day 1
measure: Comparison of social anxiety and avoidance in patients with head and neck cancer to patients with lung cancer
timeFrame: at study entry, day 1
Other outcomes:
Locations:
city: Nashville
country: United States
facility: MBCCOP - Meharry Medical College - Nashville
state: Tennessee
city: Nashville
country: United States
facility: Vanderbilt-Ingram Cancer Center
state: Tennessee
Study officials:
affiliation: Vanderbilt-Ingram Cancer Center
name: Kirsten Haman, PhD
role: PRINCIPAL_INVESTIGATOR
References: