Hearing LossUHEARNCT02381782
Validation of uHear™ as a Screening Tool to Detect Hearing Impairment in Elderly Cancer Patients Within a Comprehensive Geriatric Assessment
An observational study of Hearing Loss and Cancer, run by General Hospital Groeninge at 1 site in Belgium.
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. Read more about this study
- Who is it for?
- Ages 70 years and older
- Conditions the study is for
- Hearing Loss, Cancer
- How many people
- 33 participants
- Where
- 1 siteBelgium
- Study dates
- Dec 2014to Jun 2015
- 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: 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.
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 have signed informed consent
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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.
- Conditions
- Hearing Loss, Cancer
- Medical subject headings
- Hearing Loss, Neoplasms
What is being measured
The primary outcome is the main question the study is designed to answer.
Validation of uHear™ as a screening tool to detect hearing loss in elderly cancer patients
Measured: Baseline
Secondary outcomes (5)
To determine the prevalence of presbyacusis in an elderly cancer population
Measured: Baseline
To compare objective and subjective hearing screening measures
Measured: Baseline
To measure hearing impairment in G8 positive patients compared with G8 negative patients
Measured: Baseline
To compare uHear™ with the Whispered Voice Test
Measured: Baseline
To evaluate the use of uHear™ as a measure to determine eligibility for cisplatin treatment in elderly 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 posted6 Mar 2015 (estimated)
- Study startDec 2014
- Primary completionJun 2015
- Study completionJun 2015
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 Hearing LossStudies 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
- 33 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
- Investigators
- Philip R Debruyne, MD, PhD, Principal investigator, Cancer Center, General Hospital Groeninge
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02381782
- Sponsor's protocol ID
- AZGS2014125
- Acronym
- UHEAR
- Status last verified
- Feb 2018
- First submitted
- 5 Mar 2015
- Last updated
- 15 Feb 2018
- Results posted
- No
Publications
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.
PubMed 26924571
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 Elderly Cancer Patients Within a Comprehensive Geriatric Assessment
- ClinicalTrials.gov ID
- NCT02381782
- Acronym / sponsor ID
- UHEAR / AZGS2014125
- Conditions
- Hearing Loss, Cancer
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 33 participants (actual)
- Lead sponsor
- General Hospital GroeningeUniversity, hospital or other
- Study start
- Dec 2014
- Primary completion
- Jun 2015 (actual)
- Study completion
- Jun 2015 (actual)
- First posted
- 6 Mar 2015 (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.
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 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
- 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.
Key inclusion criteria (6 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 (4 listed)
- 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
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™ as a screening tool to detect hearing loss in elderly cancer patients
Time frame: Baseline
5 secondary outcomes
To determine the prevalence of presbyacusis in an elderly cancer population
Time frame: Baseline
To compare objective and subjective hearing screening measures
Time frame: Baseline
To measure hearing impairment in G8 positive patients compared with G8 negative patients
Time frame: Baseline
To compare uHear™ with the Whispered Voice Test
Time frame: Baseline
To evaluate the use of uHear™ as a measure to determine eligibility for cisplatin treatment in elderly 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 26924571Lycke 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.
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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.
Philip R Debruyne, MD, PhD principal investigator
Cancer Center, General Hospital Groeninge
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 Hearing Loss and Cancer, 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 6 inclusion and 4 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™ as a screening tool to detect hearing loss in elderly 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 NCT02381782, 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.