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Completed

NCT Number: NCT02381782

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

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.

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Key information

Conditions

Hearing Loss Cancer Ear Diseases Hearing Disorders Neoplasms Nervous System Diseases Neurologic Manifestations Otorhinolaryngologic Diseases Pathological Conditions, Signs and Symptoms Sensation Disorders Signs and Symptoms

Age range

70 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

General Hospital Groeninge

Kortrijk, Belgium

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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

Treatment and study plan

Primary outcomes

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

    Time frame: Baseline

Secondary outcomes

  1. To determine the prevalence of presbyacusis in an elderly cancer population

    Time frame: Baseline

  2. To compare objective and subjective hearing screening measures

    Time frame: Baseline

  3. To measure hearing impairment in G8 positive patients compared with G8 negative patients

    Time frame: Baseline

  4. To compare uHear™ with the Whispered Voice Test

    Time frame: Baseline

  5. To evaluate the use of uHear™ as a measure to determine eligibility for cisplatin treatment in elderly cancer patients

    Time frame: Baseline

Sponsors and collaborators

Lead sponsor

General Hospital Groeninge

Other

Registry information

Acronym: UHEAR

Important dates

Study start
2014
Primary completion
2015
Study completion
2015
First posted
Mar 6, 2015
Registry last updated
Feb 15, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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