NCT05789316已完成不适用
Head and Neck Cancer Survivorship Ototoxicity Screening (SOS) Protocol
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 55
- 试验地点
- 1
- 主要终点
- Rate of participants who complete audiologic follow-up
研究概览
简要总结
To evaluate the effectiveness, feasibility, acceptability, and appropriateness of an ototoxicity screening protocol among head and neck (H&N) cancer patients followed in survivorship clinic that received cisplatin-based chemoradiation therapy (CRT).
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
- •Adult (≥ 18 years old)
- •H&N cancer patients will be eligible for inclusion if they have previously undergone cisplatin-based CRT or radiotherapy, including proton therapy, intensity-modulated radiation therapy, and adaptive radiotherapy-surgery with curative intent (i.e., definitive, neoadjuvant, or adjuvant) or definitive surgery with neoadjuvant or adjuvant radiation.
排除标准
- •Patient has been evaluated by an audiologist within the past 12 months
- •Use of a hearing aid
- •Received a cochlear implant
- •Cannot complete simple forms in English
结局指标
主要结局
Rate of participants who complete audiologic follow-up
时间窗: Through completion of follow-up (estimated to be 6 months)
次要结局
- Feasibility of ototoxicity screening protocol as measured by the Feasibility of Intervention Measure(Before survivorship clinic visit (Day 1))
- Functional hearing loss of participants as measured by the Situational Management Questionnaire (SESMQ)(After survivorship clinic visit (Day 1))
- Acceptability of ototoxicity screening protocol as measured by the Acceptability of Intervention Measure(Before survivorship clinic visit (Day 1))
- Appropriateness of ototoxicity screening protocol as measured by the Intervention Appropriateness Measure(Before survivorship clinic visit (Day 1))
- Quality of life of participants as measured by the University of Washington Quality of Life Questionnaire (UW-QOL)(After survivorship clinic visit (Day 1))
- Functional social support as measured by the Duke-UNC Functional Social Support Questionnaire(After survivorship clinic visit (Day 1))
研究者
研究点 (1)
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撤回
2 期
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