Study of Anxiety and Avoidance of Others in Patients Previously Treated for Head and Neck Cancer - Full Text View

Sponsors and Collaborators:	Vanderbilt-Ingram Cancer Center National Cancer Institute (NCI)
Information provided by:	National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:	NCT00483639

Purpose

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.

Condition	Intervention
Cancer-Related Problem/Condition Head and Neck Cancer Lung Cancer	Other: medical chart review Other: questionnaire administration Other: survey administration Procedure: management of therapy complications Procedure: psychosocial assessment and care

MedlinePlus related topics: Anxiety Cancer Head and Neck Cancer Lung Cancer

U.S. FDA Resources

Study Type:	Interventional
Official Title:	Social Anxiety and Avoidance in Head and Neck Cancer Patients

Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:

Relationship between treatment-provoked social anxiety and avoidance [ Designated as safety issue: No ]
Relationship between pre-cancer psychiatric diagnosis and post-treatment social anxiety and avoidance [ Designated as safety issue: No ]
Quality of life [ Designated as safety issue: No ]
Comparison of social anxiety and avoidance in patients with head and neck cancer to patients with lung cancer [ Designated as safety issue: No ]

Estimated Enrollment:	400
Study Start Date:	November 2003
Estimated Primary Completion Date:	November 2012 (Final data collection date for primary outcome measure)

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 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

Ages Eligible for Study:	21 Years to 70 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

DISEASE 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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00483639

Locations

United States, Tennessee
MBCCOP - Meharry Medical College - Nashville
Nashville, Tennessee, United States, 37208
Vanderbilt-Ingram Cancer Center
Nashville, Tennessee, United States, 37232-6838

Sponsors and Collaborators

Vanderbilt-Ingram Cancer Center

National Cancer Institute (NCI)

Investigators

Study Chair:

Kirsten Haman, PhD

Vanderbilt-Ingram Cancer Center

More Information

Additional Information:

Clinical trial summary from the National Cancer Institute's PDQ® database This link exits the ClinicalTrials.gov site

No publications provided

Study ID Numbers:	CDR0000549423, VU-VICC-HN-0397, VU-VICC-IRB-030785
Study First Received:	June 6, 2007
Last Updated:	February 6, 2009
ClinicalTrials.gov Identifier:	NCT00483639 History of Changes
Health Authority:	United States: Federal Government

Keywords provided by National Cancer Institute (NCI):

anxiety disorder
long-term effects secondary to cancer therapy in adults
head and neck cancer
non-small cell lung cancer
small cell lung cancer

Study placed in the following topic categories:

Thoracic Neoplasms
Carcinoma, Small Cell
Respiratory Tract Diseases
Anxiety Disorders
Lung Neoplasms

Lung Diseases
Head and Neck Neoplasms
Neoplasm Metastasis
Non-small Cell Lung Cancer
Carcinoma, Non-Small-Cell Lung

Additional relevant MeSH terms:

Thoracic Neoplasms
Respiratory Tract Neoplasms
Neoplasms
Neoplasms by Site

Respiratory Tract Diseases
Lung Neoplasms
Lung Diseases
Head and Neck Neoplasms

ClinicalTrials.gov processed this record on May 07, 2009