A Web-based Multimedia Intervention for Head and Neck Cancer Patients
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 80
- 试验地点
- 2
- 主要终点
- Patient Distress
研究概览
简要总结
The overall goal is to develop and examine the acceptability of a web-based (Internet) intervention program for patients with head and neck cancer who have recently completed radiation therapy.
详细描述
The overall goal is to develop and examine the acceptability of a theory-guided, web-based multimedia intervention program for head and neck cancer patients who have recently completed radiation therapy. The effects of this intervention on patients' quality of life (QOL) will also be evaluated.
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
- •Patients with squamous cell carcinoma of the oral cavity, oropharynx, hypopharynx, or larynx
- •Are receiving or have completed radiation therapy within in the past 12 months
排除标准
- •Inability to read and/or communicate in English
- •Head and neck cancers of non-squamous histology (e.g., adenoid cystic carcinoma, adenocarcinoma, sarcoma)
- •Blindness or severity of visual impairment that precludes one's ability to view images/text
- •Inability to provide informed consent
结局指标
主要结局
Patient Distress
时间窗: Up to 6 weeks
Psychological distress will be assessed using the Brief Symptom Inventory-18. The Brief Symptom Inventory-18 (BSI-18) is an 18-item scale widely used to measure psychological distress. The BSI-18 yields a total score (Global Severity Index), which is a measure of overall psychological distress. Raw scores are converted to t-scores (range 0-100) based on gender-specific normative data from cancer patient populations. A t-score of 50 is equal to the mean of the population. Higher scores represent greater levels of distress. The BSI-18 provides a clinical case-rule classifying respondents who have a t-score score ≥ 63 on the GSI as having clinically significant symptoms. Other studies have used a lower cutoff, with a GSI t-score ≥ 57 recommended as a cutoff for clinically significant symptoms in a study of cancer patients.
次要结局
未报告次要终点