Study of Anxiety and Avoidance of Others in Patients Previously Treated for Head and Neck Cancer
![]() |
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT00483639 |
Recruitment Status
:
Completed
First Posted
: June 7, 2007
Last Update Posted
: March 15, 2013
|
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 |
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 |
|
|||
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:
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 |
|
|||
Intervention |
|
|||
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 |
100 | |||
Original Enrollment |
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:
PATIENT CHARACTERISTICS:
PRIOR CONCURRENT THERAPY:
|
|||
Sex/Gender |
|
|||
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 |
|
|||
PRS Account | Vanderbilt-Ingram Cancer Center | |||
Verification Date | March 2013 |