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临床试验/NCT02381782
NCT02381782已完成不适用

Validation of uHear™ as a Screening Tool to Detect Hearing Impairment in Elderly Cancer Patients Within a Comprehensive Geriatric Assessment

General Hospital Groeninge1 个研究点 分布在 1 个国家目标入组 33 人开始时间: 2014年12月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
33
试验地点
1
主要终点
Validation of uHear™ as a screening tool to detect hearing loss in elderly cancer patients

研究概览

简要总结

Over the last few years, there has been a considerable interest in the development of screening tools to assess the capability of elderly cancer patients to tolerate anti-cancer treatment. Therefore, the NCCN Guidelines in Senior Adult Oncology recommend an assessment of co-morbid conditions that are likely to interfere with cancer treatment and tolerability. As presbyacusis is common in an older population, elderly cancer patients are at high risk for social isolation and a reduced quality of life. Therefore, in this project the investigators aim to validatie uHear™ as a quick and reliable screening tool to screen for presbyacusisf in routine clinical oncology practice.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
70 Years 至 —(Older Adult)
性别
All
接受健康志愿者

入选标准

  • Patients should have reached the age of 70 or more at enrolment
  • Histologically confirmed diagnosis of solid cancer or hematologic malignancy. All stages of cancer are eligible
  • Patients should be fluent in Dutch or French
  • Patients must receive their primary oncology care in the participating hospital
  • Patients should be cognitively capable of performing the audiology assessment
  • Patients should have signed informed consent

排除标准

  • Patients who do not match the above inclusion criteria
  • Patients who are visiting the oncology clinic for a second opinion and do not wish to be treated in this clinic
  • Patients presenting with clinically diagnosed Ménière's disease, retrocochlear hearing loss, autoimmune inner ear disease, fluctuating hearing loss or a history of sudden sensory neural hearing loss
  • Patients who already have a hearing aid or a previously diagnosed hearing loss

结局指标

主要结局

Validation of uHear™ as a screening tool to detect hearing loss in elderly cancer patients

时间窗: Baseline

次要结局

  • To compare uHear™ with the Whispered Voice Test(Baseline)
  • To determine the prevalence of presbyacusis in an elderly cancer population(Baseline)
  • To compare objective and subjective hearing screening measures(Baseline)
  • To measure hearing impairment in G8 positive patients compared with G8 negative patients(Baseline)
  • To evaluate the use of uHear™ as a measure to determine eligibility for cisplatin treatment in elderly cancer patients(Baseline)

研究者

发起方
General Hospital Groeninge
申办方类型
Other
责任方
Principal Investigator
主要研究者

Dr. Philip Debruyne

Medical Oncologist

General Hospital Groeninge

研究点 (1)

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