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

February 14, 2018 updated by: Dr. Philip Debruyne, General Hospital Groeninge
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.

Study Overview

Status

Completed

Conditions

Study Type

Observational

Enrollment (Actual)

33

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

  • Belgium
      • Kortrijk, Belgium
        • General Hospital Groeninge

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

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.

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 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

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

  • Observational Models: Cohort
  • Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Validation of uHear™ as a screening tool to detect hearing loss in elderly cancer patients
Time Frame: Baseline
Baseline

Secondary Outcome Measures

Outcome Measure
Time Frame
To determine the prevalence of presbyacusis in an elderly cancer population
Time Frame: Baseline
Baseline
To compare objective and subjective hearing screening measures
Time Frame: Baseline
Baseline
To measure hearing impairment in G8 positive patients compared with G8 negative patients
Time Frame: Baseline
Baseline
To compare uHear™ with the Whispered Voice Test
Time Frame: Baseline
Baseline
To evaluate the use of uHear™ as a measure to determine eligibility for cisplatin treatment in elderly cancer patients
Time Frame: Baseline
Baseline

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

General Hospital Groeninge

Investigators

  • Principal Investigator: Philip R Debruyne, MD, PhD, Cancer Center, General Hospital Groeninge

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.

General Publications

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

December 1, 2014

Primary Completion (Actual)

June 1, 2015

Study Completion (Actual)

June 1, 2015

Study Registration Dates

First Submitted

March 5, 2015

First Submitted That Met QC Criteria

March 5, 2015

First Posted (Estimate)

March 6, 2015

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

  • AZGS2014125

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.

Clinical Trials on Cancer

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Guinea

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe