Pilot Testing of the Body Image After Head and Neck Cancer Treatment (BIHNC) Program
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 7
- 试验地点
- 2
- 主要终点
- Percentage of participants who complete program
研究概览
简要总结
This is a pilot study of the Body Image after Head and Neck Cancer Treatment Program [BIHNC]. It is a six-week, psychoeducational, web-based program that includes e-learning didactic modules and personal reflection activities for participants to complete.
详细描述
Specific Aim 1: To assess the feasibility and acceptability of [BIHNC] in patients who have completed treatment for head and neck cancer and who have body image concerns.
H1a: Eighty percent of enrolled study participants who complete baseline self-report measures will complete the BIHNC Program.
H1b: Eighty percent of study participants completing the BIHNC Program will rate it acceptable on the intervention evaluation form.
Specific Aim 2: To assess the preliminary efficacy of BIHNC for reducing body image concerns in patients who have completed treatment for head and neck cancer and who have body image concerns.
H2: Body image scores will improve from pre- to post- intervention
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Completion of any form of head and neck cancer treatment between 3 and 24 months previously at study enrollment
- •Answer in the affirmative to at least one of two questions concerning dissatisfaction with the way their body looks or function
- •Have clinically significant body image concerns as defined by (BIS score > 10)
排除标准
- •Undergoing head and neck cancer treatment at time of study enrollment
- •Cognitive impairment that would preclude ability to provide informed consent
- •Unable to read text on a computer screen
- •Not able to read and understand English
结局指标
主要结局
Percentage of participants who complete program
时间窗: Approximately 6 weeks
Percentage of participants who will rate program as acceptable
时间窗: Approximately 6 weeks
次要结局
- Percentage of participants with improvement in body image indicators(Approximately 6 weeks)
研究者
Bethany Rhoten
Principal Investigator
Vanderbilt-Ingram Cancer Center