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

NCT00483639 | Completed DMC

• 3 other identifiers: VICC HN 0397VU-VICC-HN-0397VU-VICC-IRB-030785
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 2

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.

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

Outcome Measures

Primary Outcomes (1)

• Level of social anxiety and avoidance in HNC patients post-treatment

  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.

  at study entry, day 1

Secondary Outcomes (3)

• Relationship between pre-cancer psychiatric diagnosis and post-treatment social anxiety and avoidance

  at study entry

• Quality of Life

  at study entry, day 1

• Comparison of social anxiety and avoidance in patients with head and neck cancer to patients with lung cancer

  at study entry, day 1

Interventions

Medical chart review OTHER

medical chart review

Liebowitz Social Anxiety Scale and the Social Phobia and Anxiety Inventory OTHER

survey administration

Also known as: survey administration

management of therapy complications PROCEDURE

management of therapy complications

Structured Clinical Interview for the Diagnostic and Statistical Manual-IV SCID PROCEDURE

psychosocial assessment

Also known as: psychosocial assessment

Functional Assessment of Cancer Therapy-General (FACT-G) OTHER

survey administration

Eligibility Criteria

• Age: 21 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

People who have been treated for head and neck cancer.

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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• Vanderbilt-Ingram Cancer Center: lead
• National Cancer Institute (NCI): collaborator

Study Sites (2)

MBCCOP - Meharry Medical College - Nashville

Nashville, Tennessee, 37208, United States

Location

Vanderbilt-Ingram Cancer Center

Nashville, Tennessee, 37232-6838, United States

Location

MeSH Terms

Conditions

Anxiety Disorders; Head and Neck Neoplasms; Lung Neoplasms; Carcinoma, Non-Small-Cell Lung; Small Cell Lung Carcinoma

Interventions

Psychiatric Rehabilitation

Condition Hierarchy (Ancestors)

Mental Disorders; Neoplasms by Site; Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Lung Diseases; Respiratory Tract Diseases; Carcinoma, Bronchogenic; Bronchial Neoplasms

Intervention Hierarchy (Ancestors)

Rehabilitation; Therapeutics; Health Services; Health Care Facilities Workforce and Services

Study Officials

• Kirsten Haman, PhD

  Vanderbilt-Ingram Cancer Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Research Assistant Professor; Psychologist

Study Record Dates

• First Submitted: June 6, 2007
• First Posted: June 7, 2007
• Study Start: November 1, 2003
• Primary Completion: March 1, 2006
• Study Completion: January 1, 2008
• Last Updated: March 15, 2013

Record last verified: 2013-03

Locations

US (2)