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临床试验/NCT04270916
NCT04270916暂停不适用

Identifying the Prevalence, Severity and the Impact on Quality of Life of Long-term Ototoxicity in Cancer Survivors: a Cross-sectional Study

University of Nottingham1 个研究点 分布在 1 个国家目标入组 46 人开始时间: 2020年2月3日最近更新:
适应症

试验速览

阶段
不适用
状态
暂停
入组人数
46
试验地点
1
主要终点
Quality of life questionnaire

研究概览

简要总结

This study will involve collaborating with oncologists in the post-chemotherapy follow-up appointments. The participants who wish to consent to this study will then answer 3 short questionnaires (THI, HHIA and SF-36) about hearing loss, tinnitus and quality of life. The audiologist or the researcher, under the supervision of an audiologist, will then perform a simple, non-invasive hearing test on the participant. Should the participant have a hearing loss, they will be advise to seek help from their General Practitioner.

详细描述

There has been a substantial increase in cancer survival rates in the the past decades, however many cancer survivors are now impacted by the multitude of toxicities associated with treatment. It is only when temporary toxicities subside that the long-term toxicities progress and become important. Chemotherapy, although highly effective, is known to cause ototoxicity, presenting as hearing loss and tinnitus. Hearing loss and tinnitus are associated with a higher risk of depression, dementia, social isolation and anxiety. There is little information and support offered to patients who suffer from ototoxicity, which can potentially lead to many being undiagnosed and untreated. Ototoxicity can be permanent and progressive, therefore it is essential that a deeper understanding and increased awareness of how hearing loss and tinnitus affects the quality of life (QoL) of cancer survivors can improve long-term symptoms Management and support offered.

This project aims to identify the prevalence and severity of long-term ototoxicity in cancer survivors following platinum-based treatment. Prevalence of ototoxicity can be unreliable and varies in the medical literature, with studies reporting rates between 24% and 79%. Information on prevalence will be achieved by recruiting patients from oncology clinics and performing a high frequency audiogram. The results from the audiogram will be compared to an normative dataset in addition to detecting self-reported hearing loss from the Hearing Handicap Inventory for Adults (HHIA) and the Hearing Handicap Inventory for Elderly (HHIE) questionnaires. Furthermore, the severity and prevalence of tinnitus will also be detected by using the Tinnitus Handicap Inventory (THI) questionnaire. A validated questionnaire assessing QoL (SF-36) after cancer will also be completed by the patients. The questionnaires will be statistically analysed and compared against a dataset from the general population in the hope to identify the concerns surrounding long-term ototoxicity in cancer survivors.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Cross Sectional

入排标准

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

入选标准

  • Ability to give informed consent
  • Age 18+ at time of cancer diagnosis
  • At least 1 cycle of any type of platinum-based chemotherapy
  • 0-5 years following first cycle of platinum-based chemotherapy
  • Comprehensive understanding of the English language

排除标准

  • Previous radiotherapy to the head and neck area
  • Pre-existing hearing deficits

结局指标

主要结局

Quality of life questionnaire

时间窗: Afer 6 months

Short form 36 item questionnaire to assess quality of life (0-100 scale, higher score means better outcome)

次要结局

  • Hearing Handicap Inventory for adults/elderly(After 6 months)
  • Tinnitus Handicap Inventory(After 6 months)
  • Hearing loss(After 6 months)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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