跳至主要内容
临床试验/NCT00483639
NCT00483639已完成不适用

Social Anxiety and Avoidance in Head and Neck Cancer Patients

Vanderbilt-Ingram Cancer Center2 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2003年11月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
100
试验地点
2
主要终点
Level of social anxiety and avoidance in HNC patients post-treatment

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Observational
观察模型
Case Control
时间视角
Prospective

入排标准

年龄范围
21 Years 至 70 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 未提供

排除标准

  • 未提供

结局指标

主要结局

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

时间窗: 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.

次要结局

  • 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)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Kirsten Haman, PhD

Research Assistant Professor; Psychologist

Vanderbilt-Ingram Cancer Center

研究点 (2)

Loading locations...

相似试验