Clinical trial NCT02381782: Validation of uHear™ as a Screening Tool to Detect Hearing Impairment in Elderly Cancer Patients Within a Comprehensive Geriatric Assessment
Official title: Validation of uHear™ as a Screening Tool to Detect Hearing Impairment in Elderly Cancer Patients Within a Comprehensive Geriatric Assessment
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Hearing Loss
Cancer
Lead sponsor: General Hospital Groeninge
Sponsor class: OTHER
First posted: 2015-03-06
Enrollment: 33
Sex: ALL
Minimum age (years): 70
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: All consenting patients, aged ≥ 70, who are referred for anti-cancer treatment in the General Hospital Groeninge and who are in need of a CGA.

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.


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

Primary outcomes:
measure: Validation of uHear™ as a screening tool to detect hearing loss in elderly cancer patients
timeFrame: Baseline
Secondary outcomes:
measure: To determine the prevalence of presbyacusis in an elderly cancer population
timeFrame: Baseline
measure: To compare objective and subjective hearing screening measures
timeFrame: Baseline
measure: To measure hearing impairment in G8 positive patients compared with G8 negative patients
timeFrame: Baseline
measure: To compare uHear™ with the Whispered Voice Test
timeFrame: Baseline
measure: To evaluate the use of uHear™ as a measure to determine eligibility for cisplatin treatment in elderly cancer patients
timeFrame: Baseline
Other outcomes:
Locations:
city: Kortrijk
country: Belgium
facility: General Hospital Groeninge
Study officials:
affiliation: Cancer Center, General Hospital Groeninge
name: Philip R Debruyne, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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 comprehensive geriatric assessment. J Geriatr Oncol. 2016 Mar;7(2):126-33. doi: 10.1016/j.jgo.2016.01.008. Epub 2016 Feb 26.