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

Tracking Information
First Submitted Date	June 6, 2007
First Posted Date	June 7, 2007
Last Update Posted Date	March 15, 2013
Study Start Date	November 2003
Actual Primary Completion Date	March 2006 (Final data collection date for primary outcome measure)
Current Primary Outcome Measures; (submitted: March 13, 2013)	Level of social anxiety and avoidance in HNC patients post-treatment [ Time Frame: at study entry, day 1 ]; 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.
Original Primary Outcome Measures	Not Provided
Change History	Complete list of historical versions of study NCT00483639 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures; (submitted: March 13, 2013)	Relationship between pre-cancer psychiatric diagnosis and post-treatment social anxiety and avoidance [ Time Frame: at study entry ]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 ]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 ]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
Original Secondary Outcome Measures	Not Provided
Current Other Outcome Measures	Not Provided
Original Other Outcome Measures	Not Provided
Descriptive Information
Brief Title	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
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.
Study Type	Observational
Study Design	Observational Model: Case Control; Time Perspective: Prospective
Target Follow-Up Duration	Not Provided
Biospecimen	Not Provided
Sampling Method	Probability Sample
Study Population	People who have been treated for head and neck cancer.
Condition	Anxiety Disorder; Head and Neck Cancer; Lung Cancer
Intervention	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; 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
Study Groups/Cohorts	Not Provided
Publications *	Not Provided
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
Recruitment Information
Recruitment Status	Completed
Actual Enrollment; (submitted: September 18, 2010)	100
Original Enrollment; (submitted: June 6, 2007)	400
Actual Study Completion Date	January 2008
Actual Primary Completion Date	March 2006 (Final data collection date for primary outcome measure)
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
Sex/Gender	Sexes Eligible for Study: All
Ages	21 Years to 70 Years (Adult, Senior)
Accepts Healthy Volunteers	No
Contacts	Contact information is only displayed when the study is recruiting subjects
Listed Location Countries	United States
Removed Location Countries
Administrative Information
NCT Number	NCT00483639
Other Study ID Numbers	VICC HN 0397; VU-VICC-HN-0397; VU-VICC-IRB-030785
Has Data Monitoring Committee	Yes
U.S. FDA-regulated Product	Not Provided
IPD Sharing Statement	Not Provided
Responsible Party	Kirsten Haman, PhD, Vanderbilt-Ingram Cancer Center
Study Sponsor	Vanderbilt-Ingram Cancer Center
Collaborators	National Cancer Institute (NCI)
Investigators	Principal Investigator: Kirsten Haman, PhD Vanderbilt-Ingram Cancer Center
PRS Account	Vanderbilt-Ingram Cancer Center
Verification Date	March 2013