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

NCT02662998 | Completed

• 1 other identifier: AZGS2015133
• Study Type: observational
• Target: 45
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Older Cancer Patients

Outcome Measures

Primary Outcomes (1)

• Validation of uHear™ with its new scoring method as a screening tool to detect hearing loss in older cancer patients

  baseline

Eligibility Criteria

• Age: 70 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• General Hospital Groeninge: lead

Study Sites (1)

General Hospital Groeninge, Cancer Center

Kortrijk, 8500, Belgium

Location

Related Publications (1)

• Lycke M, Debruyne PR, Lefebvre T, Martens E, Ketelaars L, Pottel H, Van Eygen K, Derijcke S, Werbrouck P, Vergauwe P, Stellamans K, Clarysse P, Dhooge I, Schofield P, Boterberg T. The use of uHear to screen for hearing loss in older patients with cancer as part of a comprehensive geriatric assessment. Acta Clin Belg. 2018 Apr;73(2):132-138. doi: 10.1080/17843286.2017.1392070. Epub 2017 Oct 24.

  PMID: 29063810 RESULT

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Medical Oncologist

Study Record Dates

• First Submitted: January 19, 2016
• First Posted: January 26, 2016
• Study Start: January 1, 2016
• Primary Completion: September 1, 2016
• Study Completion: September 1, 2016
• Last Updated: February 15, 2018

Record last verified: 2018-02

Locations

BE (1)