Ototoxicity Monitoring and Remote Audiometry
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 118
- 试验地点
- 2
- 主要终点
- Proportion of patients who complete at least one post-treatment audiogram
研究概览
简要总结
This clinical trial tests the impact of offering hearing tests (audiometry) close to home and remotely on participation in monitoring for treatment-related hearing loss in patients with head and neck squamous cell cancer receiving cisplatin and/or radiation. Cisplatin, a chemotherapy often used to treat head and neck cancers, and radiation given near the ear can cause hearing loss in some patients. Hearing loss can have a major negative impact on quality of life, contributing to social isolation and frustration. Identifying hearing changes may allow treatment changes to prevent further loss. Audiometry measures hearing loss using a graphic record of the softest sounds that a person can hear at various frequencies. It is recommended patients have a hearing test before, during and after treatment to monitor for any hearing loss. This is usually done in the office and performed on the same day as other visits whenever possible, however, patients who live far away or have stage IV cancer, may have more difficulty coming back for hearing tests. Offering close to home and remote audiometry may improve monitoring for hearing loss in patients with head and neck squamous cell cancer receiving cisplatin and/or radiation.
详细描述
PRIMARY OBJECTIVE:
I. To determine whether a targeted intervention of remote audiometry offered to patients with advanced disease or living > 120 miles away increases overall participation in ototoxicity monitoring.
SECONDARY OBJECTIVE:
I. To estimate the incidence and severity of cisplatin-induced hearing loss in head and neck squamous cell carcinoma (HNSCC).
TERTIARY/EXPLORATORY OBJECTIVE:
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Screening
- 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 patients, male or female, aged ≥ 18, able to provide informed consent
- •Subjects with pathologically proven HNSCC involving the oral cavity, oropharynx, larynx, hypopharynx, nasopharynx, skin, or paranasal sinuses; patients with unknown primary HNSCC involving the cervical lymph nodes can also be included. Patients can have previously untreated or recurrent/metastatic disease
- •Subjects who will be treated with cisplatin chemotherapy and/or radiation. For radiation alone, patients should have tumors near the inner ear, including the nasopharynx, temporal bone, and/or parotid salivary gland
- •Life expectancy of more than 3 months, as determined by the investigator
排除标准
- •Patients with profound hearing loss in both ears, which precludes an accurate hearing test. This can be determined based on patient report/history or audiogram done before or after informed consent
- •Patients who are unable to participate in a hearing test (per the investigator's judgment)
研究组 & 干预措施
Group II, Arm I (audiometry)
Patients undergo audiometry at WEM at baseline and at 3 and 12 months after chemotherapy and/or radiation treatment as in Group I.
干预措施: Interview (Other)
Group I (audiometry)
Patients undergo audiometry at WEM at baseline and at 3 and 12 months after chemotherapy and/or radiation treatment.
干预措施: Audiometric Test (Procedure)
Group I (audiometry)
Patients undergo audiometry at WEM at baseline and at 3 and 12 months after chemotherapy and/or radiation treatment.
干预措施: Interview (Other)
Group II, Arm I (audiometry)
Patients undergo audiometry at WEM at baseline and at 3 and 12 months after chemotherapy and/or radiation treatment as in Group I.
干预措施: Audiometric Test (Procedure)
Group II, Arm II (close to home audiometry, remote audiometry)
Patients undergo audiometry at WEM at baseline and are offered closer to home audiometry or self-administered remote audiometry at 3 and 12 months after chemotherapy and/or radiation treatment.
干预措施: Audiometric Test (Procedure)
Group II, Arm II (close to home audiometry, remote audiometry)
Patients undergo audiometry at WEM at baseline and are offered closer to home audiometry or self-administered remote audiometry at 3 and 12 months after chemotherapy and/or radiation treatment.
干预措施: Interview (Other)
结局指标
主要结局
Proportion of patients who complete at least one post-treatment audiogram
时间窗: Up to 12 months post-treatment
The incidence of follow-up audiometry relative to the targeted intervention will be assessed using a Z test for the equality of two proportions. An ordinal logistic regression analysis with mixed effects and calculations of odds ratios and 95% confidence intervals will be applied to identify associations between follow-up audiometry and intervention after adjustment for covariates including age, sex, race/ethnicity, pre-existing hearing loss, comorbidities, smoking, cisplatin dose (individual and cumulative) and cochlear radiation dose will be performed to assess whether the targeted intervention for at-risk patients is an independent predictor of increased overall participation.
次要结局
- Incidence and severity of hearing loss(Up to 30 days following cessation of study participation)
研究者
Nicole Schmitt
Principal Investigator
Emory University