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Completed

NCT Number: NCT00483639

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

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.

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Key information

Conditions

Anxiety Disorder Anxiety Disorders Bronchial Neoplasms Carcinoma, Bronchogenic Carcinoma, Non-Small-Cell Lung Head and Neck Cancer Head and Neck Neoplasms Lung Cancer Lung Diseases Lung Neoplasms Mental Disorders Neoplasms Neoplasms by Site Respiratory Tract Diseases Respiratory Tract Neoplasms Small Cell Lung Carcinoma Thoracic Neoplasms

Age range

21 year–70 year

Sex eligibility

All sexes

Study type

Observational

Primary location

MBCCOP - Meharry Medical College - Nashville, Nashville, Tennessee, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

medical chart review

Other

medical chart review

Liebowitz Social Anxiety Scale and the Social Phobia and Anxiety Inventory

Other

survey administration

Other names: 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

Other names: psychosocial assessment

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

Other

survey administration

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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.

  2. 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).

  3. 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

Sponsors and collaborators

Lead sponsor

Vanderbilt-Ingram Cancer Center

Other

Collaborators

  • National Cancer Institute (NCI)

Registry information

Official study title

Social Anxiety and Avoidance in Head and Neck Cancer Patients

Important dates

Study start
2003
Primary completion
2006
Study completion
2008
First posted
Jun 7, 2007
Registry last updated
Mar 15, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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