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

Cancer Clinical Trial

— UHEAR  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02381782
• Other study ID #: AZGS2014125
• Status: Completed
• Phase: N/A
• First received: March 5, 2015
• Last updated: February 14, 2018
• Start date: December 2014
• Est. completion date: June 2015

Study information

• Verified date: February 2018
• Source: General Hospital Groeninge
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 33
• Est. completion date: June 2015
• Est. primary completion date: June 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 70 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Cancer
• Deafness
• Hearing Loss

Locations

Country	Name	City	State
Belgium	General Hospital Groeninge	Kortrijk

Sponsors (1)

Lead Sponsor	Collaborator
General Hospital Groeninge

Country where clinical trial is conducted

Belgium, 

References & Publications (1)

Lycke M, Boterberg T, Martens E, Ketelaars L, Pottel H, Lambrecht A, Van Eygen K, De Coster L, Dhooge I, Wildiers H, Debruyne PR. Implementation of uHear™--an iOS-based application to screen for hearing loss--in older patients with cancer undergoing a com — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Validation of uHear™ as a screening tool to detect hearing loss in elderly cancer patients		Baseline
Secondary	To determine the prevalence of presbyacusis in an elderly cancer population		Baseline
Secondary	To compare objective and subjective hearing screening measures		Baseline
Secondary	To measure hearing impairment in G8 positive patients compared with G8 negative patients		Baseline
Secondary	To compare uHear™ with the Whispered Voice Test		Baseline
Secondary	To evaluate the use of uHear™ as a measure to determine eligibility for cisplatin treatment in elderly cancer patients		Baseline