- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02662998
Validation of uHear™ as a Screening Tool to Detect Hearing Impairment in Older Cancer Patients Within a Comprehensive Geriatric Assessment - BIS (UHEAR-BIS)
February 14, 2018 updated by: Dr. Philip Debruyne, General Hospital Groeninge
The aim of this study is to validate uHear™, an iOS-based tool, as a screening tool to detect significant hearing impairment as part of a comprehensive geriatric assessment in patients aged 70 years and older.
The pass or fail screening cut-off is defined as having two or more consecutive hearing grades starting from the moderate-severe threshold zone ranging from 0.5 - 2.0 kHz.
Study Overview
Status
Completed
Conditions
Study Type
Observational
Enrollment (Actual)
45
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Kortrijk, Belgium, 8500
- General Hospital Groeninge, Cancer Center
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
70 years and older (OLDER_ADULT)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Probability Sample
Study Population
This trial will recruit older patients with a minimum age of 70 years old who have been diagnosed with a solid tumour or hematologic malignancy, who are eligible for an oncogeriatric evaluation.
Description
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 be scheduled to receive a CGA
- Patients should have signed informed consent
Exclusion Criteria:
- Patients who do not match the above inclusion criteria
- Patients presenting with clinically diagnosed Meniere'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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Validation of uHear™ with its new scoring method as a screening tool to detect hearing loss in older cancer patients
Time Frame: baseline
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baseline
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
January 1, 2016
Primary Completion (Actual)
September 1, 2016
Study Completion (Actual)
September 1, 2016
Study Registration Dates
First Submitted
January 19, 2016
First Submitted That Met QC Criteria
January 21, 2016
First Posted (Estimate)
January 26, 2016
Study Record Updates
Last Update Posted (Actual)
February 15, 2018
Last Update Submitted That Met QC Criteria
February 14, 2018
Last Verified
February 1, 2018
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- AZGS2015133
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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