Ignite Creation Date:
2024-05-05 @ 5:35 PM
Last Modification Date:
2024-10-26 @ 9:33 AM
Study NCT ID:
NCT00483639
Status:
COMPLETED
Last Update Posted:
2013-03-15
First Post:
2007-06-06
Brief Title:
Study of Anxiety and Avoidance of Others in Patients Previously Treated for Head and Neck Cancer
Sponsor:
Vanderbilt-Ingram Cancer Center
Organization:
Vanderbilt-Ingram Cancer Center
Study Overview
Official Title:
Social Anxiety and Avoidance in Head and Neck Cancer Patients
Status:
COMPLETED
Status Verified Date:
2013-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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 andor 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 chemotherapyradiotherapy
Patients undergo a face-to-face interview with a mental health clinician over 2 hours Patients complete multiple psychiatricpsychological 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
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 andor 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 chemotherapyradiotherapy
Patients undergo a face-to-face interview with a mental health clinician over 2 hours Patients complete multiple psychiatricpsychological 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| VU-VICC-IRB-030785 | None | None | None |
| VU-VICC-HN-0397 | None | None | None |