Comprehensive Ototoxicity Monitoring Program for VA: A Randomized Trial

VA 综合耳毒性监测计划：随机试验

• 批准号: 9261388
• 负责人: Marilyn F. Dille
• 金额: --
• 依托单位: PORTLAND VA MEDICAL CENTER
• 依托单位国家: 美国
• 财政年份: 2014
• 资助国家: 美国
• 起止时间: 2014-04-01 至 2018-03-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/9261388
• 关键词: Address; Advocate; Aftercare; Air; Algorithms; Aminoglycosides; Antineoplastic Agents; Appointment; Attention; Audiology; Award; Awareness; Behavioral; Cancer Patient; Caring; Cisplatin; Clinic; Clinical; Clinical Trials; Communication; Counseling; Critical Illness; Data; Devices; Disabled Persons; Dose; Early Diagnosis; Early identification; Education; Effectiveness; Engineering; Ensure; Equipment; Event; Evidence based program; Feedback; Frequencies; Goals; Guidelines; Health Services Accessibility; Healthcare; Healthcare Systems; Hearing; Hearing Tests; Human Resources; Improve Access; Intervention; Lead; Leadership; Legal patent; Logistics; Malignant Neoplasms; Manuals; Measurement; Measures; Medical center; Methods; Minor; Modeling; Modification; Monitor; Motivation; Oncologist; Otoscopy; Outcome; Outer Hair Cells; Patient-Centered Care; Patients; Performance; Pharmaceutical Preparations; Pharmacotherapy; Policies; Prevention; Procedures; Process; Program Evaluation; Prothrombin; Protocols documentation; Quality of life; Questionnaires; Randomized; Recovery; Rehabilitation therapy; Relapse; Reporting; Research; Resources; Savings; Sea; Secure; Services; Side; Speech; Standardization; Suggestion; Survival Rate; System; Testing; Therapeutic; Time; Tinnitus; Treatment Factor; Tympanometry; Veterans; Work; arm; base; behavior test; cancer therapy; cell injury; chemotherapy; data exchange; design; disability; effective therapy; evidence base; follow-up; global health; health care availability; health related quality of life; hearing impairment; improved; knowledge base; oncology; otoacoustic emission; ototoxicity; patient oriented; portability; pressure; prevent; programs; public health relevance; randomized trial; rehabilitation service; standard of care; tool; treatment planning; trend; Address; Advocate; Aftercare; Air; Algorithms; Aminoglycosides; Antineoplastic Agents; Appointment; Attention; Audiology; Award; Awareness; Behavioral; Cancer Patient; Caring; Cisplatin; Clinic; Clinical; Clinical Trials; Communication; Counseling; Critical Illness; Data; Devices; Disabled Persons; Dose; Early Diagnosis; Early identification; Education; Effectiveness; Engineering; Ensure; Equipment; Event; Evidence based program; Feedback; Frequencies; Goals; Guidelines; Health Services Accessibility; Healthcare; Healthcare Systems; Hearing; Hearing Tests; Human Resources; Improve Access; Intervention; Lead; Leadership; Legal patent; Logistics; Malignant Neoplasms; Manuals; Measurement; Measures; Medical center; Methods; Minor; Modeling; Modification; Monitor; Motivation; Oncologist; Otoscopy; Outcome; Outer Hair Cells; Patient-Centered Care; Patients; Performance; Pharmaceutical Preparations; Pharmacotherapy; Policies; Prevention; Procedures; Process; Program Evaluation; Prothrombin; Protocols documentation; Quality of life; Questionnaires; Randomized; Recovery; Rehabilitation therapy; Relapse; Reporting; Research; Resources; Savings; Sea; Secure; Services; Side; Speech; Standardization; Suggestion; Survival Rate; System; Testing; Therapeutic; Time; Tinnitus; Treatment Factor; Tympanometry; Veterans; Work; arm; base; behavior test; cancer therapy; cell injury; chemotherapy; data exchange; design; disability; effective therapy; evidence base; follow-up; global health; health care availability; health related quality of life; hearing impairment; improved; knowledge base; oncology; otoacoustic emission; ototoxicity; patient oriented; portability; pressure; prevent; programs; public health relevance; randomized trial; rehabilitation service; standard of care; tool; treatment planning; trend

DESCRIPTION (provided by applicant): The goal of this research is to develop, validate and implement a comprehensive ototoxicity monitoring program for VA healthcare (COMP-VA) with both short term (during treatment) and long term (up to 3 years following randomization) objectives. VA oncology national leadership recognizes ototoxicity as an important problem for cancer patients, yet ototoxicity monitoring programs are at best under-utilized and mostly non- existent in VA. As a result, too few Veterans are able to benefit from early detection of hearing shifts during treatment, which can provide a window for the drug treatment plan to be reconsidered before hearing loss becomes disabling, and can lead to timely provision of aural rehabilitation to reduce the impacts of hearing loss incurred as a necessary consequence of treatment. Barriers that prevent the inclusion of ototoxicity monitoring into VA patient-centered care include lack of equipment and lack of access to evidence-based, time-efficient protocols exerting unwarranted pressure on limited staffing resources. Further, our data show that even with early detection, important gaps in care remain pertaining to rehabilitation. Veterans with cancer may need extra support to access these services, and a system to follow them throughout the process. Specific Aim 1 is to develop and validate an all-in-one chair side COMP-VA for cisplatin ototoxicity monitoring. To accomplish this aim, our portable OtoID audiometer system will undergo further engineering for increased functionality to include i) a highly accurate hearing change prediction tool based on Veteran and treatment factors, ii) distortion-product otoacoustic emission (DPOAE) monitoring, particularly important for critically-ill Veterans unable to be tested behaviorally and iii) incluson of time saving customizable audiological report templates with intervention and interpretation suggestions. Minimum program performance standards include hearing change prediction model accuracy to within 5 dB in the speech frequencies and nominal DPOAE false positive identification rates (5%). Specific Aim 2 is to implement and contrast COMP-VA with the current standard of care (SOC), i.e., inconsistent monitoring, in a parallel two-group randomized trial. Evidence to recommend COMP-VA as superior to the current SOC would include that i) Veterans randomized to COMP-VA access post-treatment Audiology Services at higher rates, ii) Oncologists use COMP-VA prediction and education tools when considering dose modification and they view ototoxic events as motivation for treatment modification at higher rates, and iii) Patients randomized to COMP-VA have similar relapse-free survival rates 1-3 yrs post-randomization, higher health-related quality of life outcomes, and less ototoxic- related hearing loss progression than patients randomized to SOC. The effectiveness of each clinical trial arm will be evaluated by independent personnel using audiometric measures (Program Evaluations, PE) performed prior to randomization and at 5-weeks and 1-year post-randomization. PE will include otoscopy, tympanometry, and behavioral air-conduction pure-tone hearing testing through 20 kHz. Standardized questionnaires that inquire about hearing handicap (HHIE, HHIA) and global health-related of quality of life (FACT-GP) will be given at PE #1 and #3 and at PE #3, respectively. Subjects will be contacted by the PE Audiologist at 3-month intervals starting at T=90 days post-randomization to ensure compliance with hearing protection during this period and to promote participation in the final 1-year post-randomization measurement. In addition, 120 control subjects will have hearing testing and DPOAE measures done at intervals similar to chemotherapy treatment intervals to establish DPOAE retest reference limits from which early cochlear damage can be detected. Results will considerably increase the knowledge base of the importance of monitoring ototoxicity in patients receiving ototoxic medications and will inform national policy pertaining to oncologic care and audiological preferred practice procedures. Results will also be used to determine how best to transition COMP-VA into VA healthcare nationally.

描述（由申请人提供）： 这项研究的目的是针对VA Healthcare（Comp-VA）开发，验证和实施一项全面的耳毒性监测计划，并具有短期（治疗期间）和长期（随机后最多3年）目标。 VA肿瘤学国家领导层认为耳毒性是癌症患者的重要问题，但是耳毒性监测计划充其量是充分利用的，并且在VA中大多不存在。结果，很少有退伍军人能够从治疗过程中的早期检测中发现听力转移，这可以为药物治疗计划提供一个窗口，以便在听力损失成为残疾之前重新考虑药物治疗计划，并可以及时提供听觉康复，以减少作为必要治疗后果造成听力损失的影响。阻止将耳毒性监测纳入VA患者以患者为中心的障碍包括缺乏设备以及无法获得基于证据的，耗时的协议，从而在有限的人员配备资源上施加不必要的压力。此外，我们的数据表明，即使有了早期发现，医疗保健的重要差距仍然与康复有关。患有癌症的退伍军人可能需要额外的支持才能访问这些服务，并在整个过程中跟随它们。具体目的1是开发和验证一个多合一的椅子侧comp-va，以进行顺铂耳毒性监测。为了实现这一目标，我们的便携式核苷听力计系统将进行进一步的工程，以提高功能以包括i）基于退伍军人和治疗因素的高度准确的听力变化预测工具，ii）ii）扭曲 - 产物型耳声发射（DPOAE）监控，对于迫切需要进行的定制行为，包括迫切需要报告的coptirizon和III的coptiratizodies andirizon andirizon of Praviceiizon of PravicyiiS of PraviceiiSodizosizos of III的iii of III）建议。最低程序性能标准包括听力变化预测模型的准确性在语音频率和名义DPOAE假阳性识别率（5％）中为5 dB以内的准确性（5％）。具体目标2是在平行的两组随机试验中实施和对比与当前护理标准（SOC），即不一致的监测。 Evidence to recommend COMP-VA as superior to the current SOC would include that i) Veterans randomized to COMP-VA access post-treatment Audiology Services at higher rates, ii) Oncologists use COMP-VA prediction and education tools when considering dose modification and they view ototoxic events as motivation for treatment modification at higher rates, and iii) Patients randomized to COMP-VA have similar relapse-free survival rates 1-3 yrs post-randomization,与随机分配给SOC的患者相比，与健康相关的生活质量结果更高，耳毒性相关的听力损失进展较少。每个临床试验部门的有效性将通过独立人员使用听力测量（程序评估，PE）进行评估，在随机分组前，在5周和随机后1年进行。 PE将包括耳镜，鼓膜法和通过20 kHz的行为空气传导纯音听力测试。询问听力障碍（HHIE，HHIA）和与全球健康相关的生活质量（FACT-GP）的标准化问卷将分别在PE＃1和3和PE＃3提供。 PE听力学家将以3个月的间隔与受试者联系 随机化后90天T = 90天，以确保在此期间遵守听力保护，并促进参与随机后的最后一年测量。此外，120名对照受试者将进行听力测试，并以类似于化学疗法治疗间隔的时间间隔进行DPOAE测量，以建立DPOAE重新测试参考限制，可以从中检测到早期的耳蜗损害。结果将大大提高接受耳毒药物的患者监测耳毒性重要性的知识基础，并将为与肿瘤学和听力学首选实践程序有关的国家政策提供信息。结果还将用于确定如何最好地将Comp-VA转变为全国VA医疗保健。