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Clinical Trials/NCT02381782
NCT02381782
Completed
Not Applicable

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

General Hospital Groeninge1 site in 1 country33 target enrollmentDecember 2014

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Hearing Loss
Sponsor
General Hospital Groeninge
Enrollment
33
Locations
1
Primary Endpoint
Validation of uHear™ as a screening tool to detect hearing loss in elderly cancer patients
Status
Completed
Last Updated
8 years ago

Overview

Brief Summary

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.

Registry
clinicaltrials.gov
Start Date
December 2014
End Date
June 2015
Last Updated
8 years ago
Study Type
Observational
Sex
All

Investigators

Sponsor
General Hospital Groeninge
Responsible Party
Principal Investigator
Principal Investigator

Dr. Philip Debruyne

Medical Oncologist

General Hospital Groeninge

Eligibility Criteria

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

Outcomes

Primary Outcomes

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

Time Frame: Baseline

Secondary Outcomes

  • 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)

Study Sites (1)

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