Older Cancer PatientsUHEAR-BISNCT02662998
Validation of uHear™ as a Screening Tool to Detect Hearing Impairment in Older Cancer Patients Within a Comprehensive Geriatric Assessment - BIS
An observational study of Older Cancer Patients, run by General Hospital Groeninge at 1 site in Belgium.
Trial 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. Read more about this study
- Who is it for?
- Ages 70 years and older
- Conditions the study is for
- Older Cancer Patients
- How many people
- 45 participants
- Where
- 1 siteBelgium
- Study dates
- Jan 2016to Sep 2016
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 70 years and older
- All sexes
- No healthy volunteers
- Older adult
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.
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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
What is being measured
The primary outcome is the main question the study is designed to answer.
Validation of uHear™ with its new scoring method as a screening tool to detect hearing loss in older cancer patients
Measured: baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jan 2016 (estimated)
- Study startJan 2016
- Primary completionSep 2016
- Study completionSep 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Older Cancer PatientsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 45 participants (actual)
Sponsor and investigators
- Lead sponsor
- General Hospital Groeninge
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr. Philip Debruyne, General Hospital Groeninge
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02662998
- Sponsor's protocol ID
- AZGS2015133
- Acronym
- UHEAR-BIS
- Status last verified
- Feb 2018
- First submitted
- 19 Jan 2016
- Last updated
- 15 Feb 2018
- Results posted
- No
Publications
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.
PubMed 29063810
Study at a glance
From the registry record, last updated by the sponsor on 15 Feb 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Validation of uHear™ as a Screening Tool to Detect Hearing Impairment in Older Cancer Patients Within a Comprehensive Geriatric Assessment - BIS
- ClinicalTrials.gov ID
- NCT02662998
- Acronym / sponsor ID
- UHEAR-BIS / AZGS2015133
- Conditions
- Older Cancer Patients
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 45 participants (actual)
- Lead sponsor
- General Hospital GroeningeUniversity, hospital or other
- Study start
- Jan 2016
- Primary completion
- Sep 2016 (actual)
- Study completion
- Sep 2016 (actual)
- First posted
- 26 Jan 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 70 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
- 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.
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Validation of uHear™ with its new scoring method as a screening tool to detect hearing loss in older cancer patients
Time frame: baseline
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Feb 2018.
- Results publication: PubMed 29063810Lycke 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Older Cancer Patients, run by General Hospital Groeninge at 1 site in Belgium.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Feb 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Validation of uHear™ with its new scoring method as a screening tool to detect hearing loss in older cancer patients (time frame: baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02662998, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Feb 2018.