Head and Neck Cancer Survivorship Ototoxicity Screening (SOS) Protocol
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
研究组 & 干预措施
Ototoxicity Screening Protocol
After enrollment, participants will complete a pre-screening survey. Before their survivorship clinic visit, participants will complete the ototoxicity screening protocol and implementation outcome surveys. During their visit, they will receive counseling on ototoxicity and referral to audiology. After their visit, they will complete the SESMQ and WU-QOLv4 surveys and undergo pure tone audiometry. Each participant will complete this protocol once. The investigators will follow each participant by chart review for at least six months to evaluate for audiologic follow-up.
干预措施: Ototoxicity Screening Protocol (Other)
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))