Childhood CancerHEARNCT06036407
Screening for Hearing Loss After Childhood Cancer
A study testing Hearing test in people with Childhood Cancer and Hearing Loss, run by University of Bern at 1 site in Switzerland.
Trial summary
The HEAR-study pilots and evaluates a national, low-threshold screening program to detect hearing problems in Swiss adult childhood cancer survivors. Participants will conduct a hearing test in a local hearing aid shop and report about their experiences at the shop in questionnaires and interviews. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Childhood Cancer, Hearing Loss
- What is being tested?
- Hearing test
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 476 participants
- Where
- 1 siteSwitzerland
- Study dates
- 5 Jul 2022to 1 Nov 2024
- Phase
- Interventional
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diagnosed with childhood cancer according to the international classification of childhood cancer, edition 3 (ICCC3) main groups
- Diagnosed before the age 21
- Diagnosed in Switzerland
- Registered in the Swiss Childhood Cancer Registry
- Recovered \& survived ≥2 years after diagnosis
- Diagnosed between 1976-2019
Show all 9Show fewer
- Treated in one of the clinics of the Swiss Paediatric Oncology Group
- Exposed to any chemotherapy and/or radiation to the head, neck or spine (TBI included)
- Written informed consent
Who cannot join
- Recently contacted for other studies (January 2022-July 2022)
- Not German/French speaking
- No postal address available
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Improving Access to Screening for Hearing Loss After Childhood Cancer - a Novel Community-based Approach
The HEAR-study pilots and evaluates a national, low-threshold screening program to detect hearing problems in Swiss adult childhood cancer survivors.
Participants will conduct a hearing test in a local hearing aid shop and report about their experiences at the shop in questionnaires and interviews. The screening program will be evaluated using the RE-AIM framework.
Read the detailed description
Hearing loss is an adverse event in childhood cancer survivors (CCS). It is caused by ototoxic cancer treatments, in particular platinum chemotherapy, cranial radiation with doses of ≥30 Gray, and surgery involving the auditory system.
Undetected hearing loss, even if mild, can have a strong impact on life. It affects language acquisition in infants, school performance and communication, thus interfering with survivors' professional life, social integration, and quality of life. Although hearing loss is irreversible in most CCS, it can be treated with speech therapy or hearing aids; therefore, early detection is important. Unfortunately, one third of CCS in Switzerland with ototoxic treatment did not get auditory follow-up screening after completion of acute cancer treatment.
CCS in follow-up care are often discharged to primary care, particularly for late effects that are not life threatening such as hearing loss. Multidisciplinary follow-up clinics for adult CCS were recently initiated in Switzerland. These provide risk-adapted individual examinations and counseling for CCS by organizing several medical examinations within one or two days, but capacity is limited. Additionally, extended visits in large hospitals are costly for the healthcare system and time-consuming for CCS. Low-threshold screening programs that are easily accessible and less time-consuming might therefore be a valuable addition to improve screening for hearing loss among CCS.
The main rationale for this study is to test a novel community-based, low-threshold screening approach for hearing loss in CCS in Switzerland. The screening program is tested and evaluated using the RE-AIM (reach, effectiveness, adoption, implementation, maintenance) framework for assessing health interventions including reach, effectiveness, adoption, implementation and maintenance (see outcome measures). The second aim is to use the data obtained to close knowledge gaps on risk factors of ototoxicity after childhood cancer. This will eventually lead to improved care and higher quality of life for affected CCS.
- Conditions
- Childhood Cancer, Hearing Loss
- Being tested
- Hearing test
- Keywords
- Ototoxicity, Late Effect, Ototoxic, Follow-up care, Screening
- Medical subject headings
- Neoplasms, Hearing Loss, Ototoxicity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hearing testDiagnostic test
Also called Hearing evaluation, Hearing assessment, Hearing screening
Participants visit a local hearing aid shop to assess their hearing function
| Study group | Role | What they receive |
|---|---|---|
| Participants | Experimental | Participants make an appointment at a hearing aid shop in Switzerland. They get the results right after the hearing test and may take it to their respective physician if wanted. Receives: Diagnostic Test: Hearing test |
What is being measured
The primary outcome is the main question the study is designed to answer.
Reach: Number/proportion of written informed consents
Reach measures to which extent the target population participates in the program by assessing representativeness and participant population coverage.
Number of written informed consents is counted and divided by the number of people invited to get the response rate.
Measured: 1 day after signed informed consent is sent back
Reach: Number/proportion of participants that consented, who participated in screening program (i.e. completed hearing test)
Number of participants that conducted hearing test is counted and divided by the number of people that consented to participate in the screening program.
Measured: 4 weeks after participant completed hearing test
Reach: Comparing characteristics of (non-)responders
Characteristics of responders (signed informed consent) are compared to those of non-responders. Data from the childhood cancer registry on age at study, age at diagnosis, diagnosis, treatment regimens and urbanicity are extracted and compared by using cross-field tabulations and chi-square tests for categorical variables and independent sample t-tests and analysis of variance for continuous variables.
This comparison gives information on the representativeness of the study population.
Measured: 1 day after signed informed consent is sent back
Reach: Motives for participation
Motives for participation are assessed through interviews with study participants after the hearing test. They are asked why they participated.
Measured: 3 months after participant completed hearing test
Effectiveness: Number/proportion of participants with (newly) detected hearing loss
Effectiveness focuses on evaluating immediate and long-term impacts (positive and negative) of the intervention. It examines whether the intervention achieves its objectives (i.e., detecting hearing loss) and what other impacts it might have (e.g. mental health).
Participants fill out two follow-up questionnaires 4 weeks after the hearing test and 6 months after the hearing test. In the first follow-up questionnaire, participants are asked what the result of the hearing test was. This data is compared to a baseline data that is collected through a questionnaire before the hearing test. Numbers of hearing impaired persons at baseline and at follow up are then compared.
Measured: 4 weeks after participant completed hearing test
Effectiveness: Number/proportion of participants with (newly) detected hearing loss who contacted their treating healthcare professional.
In the second follow-up questionnaire, participants are asked, if they consulted a physician after receiving their hearing test result and if they have done something about their hearing impairment (if present). These numbers give information on the impact of the screening program on the population (e.g. new hearing aids).
Measured: 6 months after participant completed hearing test
Effectiveness: Other possible effects on mental health (newly detected hearing loss, reminded of disease)
In the interviews with study participants after the hearing test, they are asked how they felt before, during and after the hearing test and if something changed in their lifes since they got their hearing test results.
Emerging topics are collected, analysed and integrated in the second follow-up questionnaire to get more information from more participants.
Measured: 3 months after participant completed hearing test
Adoption: Satisfaction, opinions and suggestions of participants and key stakeholders
Adoption assesses how the program is adopted by target settings (i.e., hearing aid shops, health care professionals), assessing stakeholder's willingness/readiness to adopt and implement the intervention.
In interviews with study participants, they are asked about their experiences with the screening program, how it compared to existing follow-up care programs, its advantages and disadvantages and their overall opinions on the program.
To get insight from all stakeholders involved, acousticians from the hearing aid shops and health care professionals from the fields of pediatric oncology, follow-up care and/or audiology are also interrogated.
Acousticians and health care professionals are asked for their opinions on the program and suggestions for improvement. Further, they are asked for challenges or difficulties they encountered or anticipated.
Measured: 3 months after participant completed hearing test
Adoption: Geographical distribution of hearing aid shops visited during the study
To get insight on how the program was used by the study population, observational data from the hearing aid provider are collected to see where the participants visited the hearing aid shops.
Measured: 4 weeks after participant completed hearing test
Implementation: Fidelity and consistency to the intervention protocol.
Implementation evaluates the feasibility of implementing the intervention within real-world contexts, assessing the extent to which the intervention is delivered consistently and as intended. It also includes required resources.
In the interviews with acousticians, they are asked about their experiences with study participants during the hearing test. They are asked if study participants differ from usual customers and in what way and if they treated them differently than usual customers (i.e. find out if they changed protocol in some way).
Further, they are asked if they reached capacity limits in their respective hearing aid shops and if they needed additional resources (than usual).
These interviews inform the design of a questionnaire to all acousticians that performed hearing tests on a study participant to get more information from more persons.
Measured: Six months after hearing test
Implementation: Estimated costs for implementation
Costs for implementation are calculated based on empirical values and data from the hearing aid shops: Work time, infrastructure, skills, expertises.
Measured: Six months after hearing test
Maintenance: Opinions of stakeholders and participants on the continuation of the screening program
Maintenance investigates the possibility of continuing the program beyond the research project, considering its long-term sustainability.
Assessed through interviews with and questionnaires to participants and stakeholders:
- Opinions of stakeholders and participants on the continuation of the screening program
- Identification of necessary requirements and resources for the program's future continuation
- Potential integration of the program into the existing follow-up care programs for childhood cancer survivors
Measured: Six months after participant conducted hearing test
Secondary outcomes (2)
Assessing hearing function in childhood cancer survivors
Audiograms of adult CCS in Switzerland are collected from the hearing tests. The hearing function is then assessed using the International Society of Paediatric Oncology (SIOP) Boston Ototoxicity Scale for grading hearing loss.
Measured: Examinations (hearing tests) between July 2022 and July 2023
Identify risk factors for hearing loss in CCS
Data from the childhood cancer registry on age at study, age at diagnosis, diagnosis, treatment regimens as well as from questionnaires (environmental risk factors) are extracted and used to identify risk factors associated with hearing loss.
Risk factors are identified by calculating Odds Ratios using univariable and multivariable logistic regression.
Measured: Hearing test results between July 2022 and July 2023
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Sep 2023
- Study start5 Jul 2022
- Primary completion15 Jul 2023
- Study completion1 Nov 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (13)Papers the sponsor has linked to this study.
- Other trials for Childhood CancerStudies of the same condition, open and under way.
- More trials run by University of BernThe sponsor's other registered studies.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Screening
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 476 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Bern
- Sponsor type
- University, hospital or other
- Collaborators
- Krebsforschung Schweiz, Bern, Switzerland
- Responsible party
- Sponsor
- Investigators
- Claudia Kuehni, MD, Principal investigator, Institute of Social and Preventive Medicine, University of Bern
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06036407
- Sponsor's protocol ID
- SCCSS_Ototox
- Acronym
- HEAR
- Status last verified
- Apr 2026
- First submitted
- 28 Aug 2023
- Last updated
- 14 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Weiss A, Sommer G, Kasteler R, Scheinemann K, Grotzer M, Kompis M, Kuehni CE; Swiss Pediatric Oncology Group (SPOG). Long-term auditory complications after childhood cancer: A report from the Swiss Childhood Cancer Survivor Study. Pediatr Blood Cancer. 2017 Feb;64(2):364-373. doi: 10.1002/pbc.26212. Epub 2016 Sep 21.
PubMed 27650356Clemens E, van den Heuvel-Eibrink MM, Mulder RL, Kremer LCM, Hudson MM, Skinner R, Constine LS, Bass JK, Kuehni CE, Langer T, van Dalen EC, Bardi E, Bonne NX, Brock PR, Brooks B, Carleton B, Caron E, Chang KW, Johnston K, Knight K, Nathan PC, Orgel E, Prasad PK, Rottenberg J, Scheinemann K, de Vries ACH, Walwyn T, Weiss A, Am Zehnhoff-Dinnesen A, Cohn RJ, Landier W; International Guideline Harmonization Group ototoxicity group. Recommendations for ototoxicity surveillance for childhood, adolescent, and young adult cancer survivors: a report from the International Late Effects of Childhood Cancer Guideline Harmonization Group in collaboration with the PanCare Consortium. Lancet Oncol. 2019 Jan;20(1):e29-e41. doi: 10.1016/S1470-2045(18)30858-1.
PubMed 30614474Bass JK, Liu W, Banerjee P, Brinkman TM, Mulrooney DA, Gajjar A, Pappo AS, Merchant TE, Armstrong GT, Srivastava D, Robison LL, Hudson MM, Krull KR. Association of Hearing Impairment With Neurocognition in Survivors of Childhood Cancer. JAMA Oncol. 2020 Sep 1;6(9):1363-1371. doi: 10.1001/jamaoncol.2020.2822.
PubMed 32729886Weiss A, Sommer G, Schindera C, Wengenroth L, Karow A, Diezi M, Michel G, Kuehni CE; Swiss Paediatric Oncology Group (SPOG). Hearing loss and quality of life in survivors of paediatric CNS tumours and other cancers. Qual Life Res. 2019 Feb;28(2):515-521. doi: 10.1007/s11136-018-2021-2. Epub 2018 Oct 10.
PubMed 30306534Khairi Md Daud M, Noor RM, Rahman NA, Sidek DS, Mohamad A. The effect of mild hearing loss on academic performance in primary school children. Int J Pediatr Otorhinolaryngol. 2010 Jan;74(1):67-70. doi: 10.1016/j.ijporl.2009.10.013. Epub 2009 Nov 12.
PubMed 19913305Weiss A, Kuonen R, Brockmeier H, Grotzer M, Candreia C, Maire R, Senn P, Stieger C, Rosenfeld J, Veraguth D, Kompis M, Scheinemann K, Kuehni CE; Swiss Pediatric Oncology Group (SPOG). Audiological monitoring in Swiss childhood cancer patients. Pediatr Blood Cancer. 2018 Mar;65(3). doi: 10.1002/pbc.26877. Epub 2017 Dec 12.
PubMed 29230928Babecoff S, Mermillod F, Marino D, Gayet-Ageron A, Ansari M, Fernandez E, Gumy-Pause F. Long-term follow-up for childhood cancer survivors: the Geneva experience. Swiss Med Wkly. 2022 Apr 7;152:w30153. doi: 10.4414/smw.2022.w30153. eCollection 2022 Mar 28.
PubMed 35429234Michel G, Kuehni CE, Rebholz CE, Zimmermann K, Eiser C, Rueegg CS, von der Weid NX; Swiss Paediatric Oncology Group (SPOG). Can health beliefs help in explaining attendance to follow-up care? The Swiss childhood cancer survivor study. Psychooncology. 2011 Oct;20(10):1034-43. doi: 10.1002/pon.1823. Epub 2010 Aug 4.
PubMed 20687196Michel G, Gianinazzi ME, Eiser C, Bergstraesser E, Vetsch J, von der Weid N, Kuehni CE; Swiss Paediatric Oncology Group. Preferences for long-term follow-up care in childhood cancer survivors. Eur J Cancer Care (Engl). 2016 Nov;25(6):1024-1033. doi: 10.1111/ecc.12560. Epub 2016 Aug 23.
PubMed 27550385Jorger P, Nigg C, Zarkovic M, Sommer G, Kompis M, Michel G, Ansari M, Waespe N, Kuehni CE. Awareness about the risk of hearing loss after ototoxic treatments in Swiss childhood cancer survivors. Patient Educ Couns. 2025 Jul;136:108764. doi: 10.1016/j.pec.2025.108764. Epub 2025 Mar 27.
PubMed 40179545Jorger P, Nigg C, Schindera C, Zarkovic M, Sommer G, Kompis M, Frahsa A, Waespe N, Ansari M, Kuehni CE. Evaluation of a New, Community-Based Screening Program to Detect Hearing Loss in Adult Childhood Cancer Survivors in Switzerland: Findings From the HEAR Study. Pediatr Blood Cancer. 2026 Jun;73(6):e70287. doi: 10.1002/1545-5017.70287. Epub 2026 Apr 6.
PubMed 41943511Jorger P, Nigg C, Mader L, Strebel S, Kompis M, Tomasikova Z, Schindera C, Michel G, von der Weid NX, Ansari M, Waespe N, Kuehni CE. A Health Service Research Study on a Low-Threshold Hearing Screening Program for Childhood Cancer Survivors in Switzerland: Protocol for the HEAR Study. JMIR Res Protoc. 2025 May 21;14:e63627. doi: 10.2196/63627.
PubMed 40397950Jorger P, Nigg C, Schreck L, Schindera C, Fessler K, Waespe N, Tomasikova Z, Ansari M, Frahsa A, Kuehni CE. Hearing screening beyond the clinic: Childhood cancer survivors' perspectives on a novel hearing screening program. BMC Health Serv Res. 2026 Apr 11;26(1):724. doi: 10.1186/s12913-026-14491-5.
PubMed 41965725
Study at a glance
From the registry record, last updated by the sponsor on 14 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Improving Access to Screening for Hearing Loss After Childhood Cancer - a Novel Community-based Approach
- ClinicalTrials.gov ID
- NCT06036407
- Acronym / sponsor ID
- HEAR / SCCSS_Ototox
- Conditions
- Childhood Cancer, Hearing Loss
- Keywords
- Ototoxicity, Late Effect, Ototoxic, Follow-up care, Screening
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 476 participants (actual)
- Lead sponsor
- University of BernUniversity, hospital or other
- Collaborators
- Krebsforschung Schweiz, Bern, Switzerland
- Study start
- 5 Jul 2022 (actual)
- Primary completion
- 15 Jul 2023 (actual)
- Study completion
- 1 Nov 2024 (actual)
- First posted
- 13 Sep 2023 (actual)
- 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 HEAR-study pilots and evaluates a national, low-threshold screening program to detect hearing problems in Swiss adult childhood cancer survivors.
Participants will conduct a hearing test in a local hearing aid shop and report about their experiences at the shop in questionnaires and interviews. The screening program will be evaluated using the RE-AIM framework.
Detailed description
Hearing loss is an adverse event in childhood cancer survivors (CCS). It is caused by ototoxic cancer treatments, in particular platinum chemotherapy, cranial radiation with doses of ≥30 Gray, and surgery involving the auditory system.
Undetected hearing loss, even if mild, can have a strong impact on life. It affects language acquisition in infants, school performance and communication, thus interfering with survivors' professional life, social integration, and quality of life. Although hearing loss is irreversible in most CCS, it can be treated with speech therapy or hearing aids; therefore, early detection is important. Unfortunately, one third of CCS in Switzerland with ototoxic treatment did not get auditory follow-up screening after completion of acute cancer treatment.
CCS in follow-up care are often discharged to primary care, particularly for late effects that are not life threatening such as hearing loss. Multidisciplinary follow-up clinics for adult CCS were recently initiated in Switzerland. These provide risk-adapted individual examinations and counseling for CCS by organizing several medical examinations within one or two days, but capacity is limited. Additionally, extended visits in large hospitals are costly for the healthcare system and time-consuming for CCS. Low-threshold screening programs that are easily accessible and less time-consuming might therefore be a valuable addition to improve screening for hearing loss among CCS.
The main rationale for this study is to test a novel community-based, low-threshold screening approach for hearing loss in CCS in Switzerland. The screening program is tested and evaluated using the RE-AIM (reach, effectiveness, adoption, implementation, maintenance) framework for assessing health interventions including reach, effectiveness, adoption, implementation and maintenance (see outcome measures). The second aim is to use the data obtained to close knowledge gaps on risk factors of ototoxicity after childhood cancer. This will eventually lead to improved care and higher quality of life for affected CCS.
Study design
- Primary purpose
- Screening
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Participants | Experimental | Diagnostic Test: Hearing testParticipants make an appointment at a hearing aid shop in Switzerland. They get the results right after the hearing test and may take it to their respective physician if wanted. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Diagnosed with childhood cancer according to the international classification of childhood cancer, edition 3 (ICCC3) main groups
- Diagnosed before the age 21
- Diagnosed in Switzerland
- Registered in the Swiss Childhood Cancer Registry
- Recovered \& survived ≥2 years after diagnosis
Key exclusion criteria (3 listed)
- Recently contacted for other studies (January 2022-July 2022)
- Not German/French speaking
- No postal address available
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Hearing testAlso: Hearing evaluation, Hearing assessment, Hearing screeningParticipants visit a local hearing aid shop to assess their hearing function | Diagnostic test | Participants |
Primary outcome
Reach: Number/proportion of written informed consents
Time frame: 1 day after signed informed consent is sent back
Reach measures to which extent the target population participates in the program by assessing representativeness and participant population coverage. Number of written informed consents is counted and divided by the number of people invited to get the response rate.
Reach: Number/proportion of participants that consented, who participated in screening program (i.e. completed hearing test)
Time frame: 4 weeks after participant completed hearing test
Number of participants that conducted hearing test is counted and divided by the number of people that consented to participate in the screening program.
Reach: Comparing characteristics of (non-)responders
Time frame: 1 day after signed informed consent is sent back
Characteristics of responders (signed informed consent) are compared to those of non-responders. Data from the childhood cancer registry on age at study, age at diagnosis, diagnosis, treatment regimens and urbanicity are extracted and compared by using cross-field tabulations and chi-square tests for categorical variables and independent sample t-tests and analysis of variance for continuous variables. This comparison gives information on the representativeness of the study population.
Reach: Motives for participation
Time frame: 3 months after participant completed hearing test
Motives for participation are assessed through interviews with study participants after the hearing test. They are asked why they participated.
Effectiveness: Number/proportion of participants with (newly) detected hearing loss
Time frame: 4 weeks after participant completed hearing test
Effectiveness focuses on evaluating immediate and long-term impacts (positive and negative) of the intervention. It examines whether the intervention achieves its objectives (i.e., detecting hearing loss) and what other impacts it might have (e.g. mental health). Participants fill out two follow-up questionnaires 4 weeks after the hearing test and 6 months after the hearing test. In the first follow-up questionnaire, participants are asked what the result of the hearing test was. This data is compared to a baseline data that is collected through a questionnaire before the hearing test. Numbers of hearing impaired persons at baseline and at follow up are then compared.
Effectiveness: Number/proportion of participants with (newly) detected hearing loss who contacted their treating healthcare professional.
Time frame: 6 months after participant completed hearing test
In the second follow-up questionnaire, participants are asked, if they consulted a physician after receiving their hearing test result and if they have done something about their hearing impairment (if present). These numbers give information on the impact of the screening program on the population (e.g. new hearing aids).
Effectiveness: Other possible effects on mental health (newly detected hearing loss, reminded of disease)
Time frame: 3 months after participant completed hearing test
In the interviews with study participants after the hearing test, they are asked how they felt before, during and after the hearing test and if something changed in their lifes since they got their hearing test results. Emerging topics are collected, analysed and integrated in the second follow-up questionnaire to get more information from more participants.
Adoption: Satisfaction, opinions and suggestions of participants and key stakeholders
Time frame: 3 months after participant completed hearing test
Adoption assesses how the program is adopted by target settings (i.e., hearing aid shops, health care professionals), assessing stakeholder's willingness/readiness to adopt and implement the intervention. In interviews with study participants, they are asked about their experiences with the screening program, how it compared to existing follow-up care programs, its advantages and disadvantages and their overall opinions on the program. To get insight from all stakeholders involved, acousticians from the hearing aid shops and health care professionals from the fields of pediatric oncology, follow-up care and/or audiology are also interrogated. Acousticians and health care professionals are asked for their opinions on the program and suggestions for improvement. Further, they are asked for challenges or difficulties they encountered or anticipated.
Adoption: Geographical distribution of hearing aid shops visited during the study
Time frame: 4 weeks after participant completed hearing test
To get insight on how the program was used by the study population, observational data from the hearing aid provider are collected to see where the participants visited the hearing aid shops.
Implementation: Fidelity and consistency to the intervention protocol.
Time frame: Six months after hearing test
Implementation evaluates the feasibility of implementing the intervention within real-world contexts, assessing the extent to which the intervention is delivered consistently and as intended. It also includes required resources. In the interviews with acousticians, they are asked about their experiences with study participants during the hearing test. They are asked if study participants differ from usual customers and in what way and if they treated them differently than usual customers (i.e. find out if they changed protocol in some way). Further, they are asked if they reached capacity limits in their respective hearing aid shops and if they needed additional resources (than usual). These interviews inform the design of a questionnaire to all acousticians that performed hearing tests on a study participant to get more information from more persons.
Implementation: Estimated costs for implementation
Time frame: Six months after hearing test
Costs for implementation are calculated based on empirical values and data from the hearing aid shops: Work time, infrastructure, skills, expertises.
Maintenance: Opinions of stakeholders and participants on the continuation of the screening program
Time frame: Six months after participant conducted hearing test
Maintenance investigates the possibility of continuing the program beyond the research project, considering its long-term sustainability. Assessed through interviews with and questionnaires to participants and stakeholders: * Opinions of stakeholders and participants on the continuation of the screening program * Identification of necessary requirements and resources for the program's future continuation * Potential integration of the program into the existing follow-up care programs for childhood cancer survivors
2 secondary outcomes
Assessing hearing function in childhood cancer survivors
Time frame: Examinations (hearing tests) between July 2022 and July 2023
Identify risk factors for hearing loss in CCS
Time frame: Hearing test results between July 2022 and July 2023
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 14 Apr 2026.
- Background: PubMed 27650356Weiss A, Sommer G, Kasteler R, Scheinemann K, Grotzer M, Kompis M, Kuehni CE; Swiss Pediatric Oncology Group (SPOG). Long-term auditory complications after childhood cancer: A report from the Swiss Childhood Cancer Survivor Study. Pediatr Blood Cancer. 2017 Feb;64(2):364-373. doi: 10.1002/pbc.26212. Epub 2016 Sep 21.
- Background: PubMed 30614474Clemens E, van den Heuvel-Eibrink MM, Mulder RL, Kremer LCM, Hudson MM, Skinner R, Constine LS, Bass JK, Kuehni CE, Langer T, van Dalen EC, Bardi E, Bonne NX, Brock PR, Brooks B, Carleton B, Caron E, Chang KW, Johnston K, Knight K, Nathan PC, Orgel E, Prasad PK, Rottenberg J, Scheinemann K, de Vries ACH, Walwyn T, Weiss A, Am Zehnhoff-Dinnesen A, Cohn RJ, Landier W; International Guideline Harmonization Group ototoxicity group. Recommendations for ototoxicity surveillance for childhood, adolescent, and young adult cancer survivors: a report from the International Late Effects of Childhood Cancer Guideline Harmonization Group in collaboration with the PanCare Consortium. Lancet Oncol. 2019 Jan;20(1):e29-e41. doi: 10.1016/S1470-2045(18)30858-1.
- Background: PubMed 32729886Bass JK, Liu W, Banerjee P, Brinkman TM, Mulrooney DA, Gajjar A, Pappo AS, Merchant TE, Armstrong GT, Srivastava D, Robison LL, Hudson MM, Krull KR. Association of Hearing Impairment With Neurocognition in Survivors of Childhood Cancer. JAMA Oncol. 2020 Sep 1;6(9):1363-1371. doi: 10.1001/jamaoncol.2020.2822.
- Background: PubMed 30306534Weiss A, Sommer G, Schindera C, Wengenroth L, Karow A, Diezi M, Michel G, Kuehni CE; Swiss Paediatric Oncology Group (SPOG). Hearing loss and quality of life in survivors of paediatric CNS tumours and other cancers. Qual Life Res. 2019 Feb;28(2):515-521. doi: 10.1007/s11136-018-2021-2. Epub 2018 Oct 10.
- Background: PubMed 19913305Khairi Md Daud M, Noor RM, Rahman NA, Sidek DS, Mohamad A. The effect of mild hearing loss on academic performance in primary school children. Int J Pediatr Otorhinolaryngol. 2010 Jan;74(1):67-70. doi: 10.1016/j.ijporl.2009.10.013. Epub 2009 Nov 12.
- Background: PubMed 29230928Weiss A, Kuonen R, Brockmeier H, Grotzer M, Candreia C, Maire R, Senn P, Stieger C, Rosenfeld J, Veraguth D, Kompis M, Scheinemann K, Kuehni CE; Swiss Pediatric Oncology Group (SPOG). Audiological monitoring in Swiss childhood cancer patients. Pediatr Blood Cancer. 2018 Mar;65(3). doi: 10.1002/pbc.26877. Epub 2017 Dec 12.
- Background: PubMed 35429234Babecoff S, Mermillod F, Marino D, Gayet-Ageron A, Ansari M, Fernandez E, Gumy-Pause F. Long-term follow-up for childhood cancer survivors: the Geneva experience. Swiss Med Wkly. 2022 Apr 7;152:w30153. doi: 10.4414/smw.2022.w30153. eCollection 2022 Mar 28.
- Background: PubMed 20687196Michel G, Kuehni CE, Rebholz CE, Zimmermann K, Eiser C, Rueegg CS, von der Weid NX; Swiss Paediatric Oncology Group (SPOG). Can health beliefs help in explaining attendance to follow-up care? The Swiss childhood cancer survivor study. Psychooncology. 2011 Oct;20(10):1034-43. doi: 10.1002/pon.1823. Epub 2010 Aug 4.
- Background: PubMed 27550385Michel G, Gianinazzi ME, Eiser C, Bergstraesser E, Vetsch J, von der Weid N, Kuehni CE; Swiss Paediatric Oncology Group. Preferences for long-term follow-up care in childhood cancer survivors. Eur J Cancer Care (Engl). 2016 Nov;25(6):1024-1033. doi: 10.1111/ecc.12560. Epub 2016 Aug 23.
- Results publication: PubMed 40179545Jorger P, Nigg C, Zarkovic M, Sommer G, Kompis M, Michel G, Ansari M, Waespe N, Kuehni CE. Awareness about the risk of hearing loss after ototoxic treatments in Swiss childhood cancer survivors. Patient Educ Couns. 2025 Jul;136:108764. doi: 10.1016/j.pec.2025.108764. Epub 2025 Mar 27.
- Results publication: PubMed 41943511Jorger P, Nigg C, Schindera C, Zarkovic M, Sommer G, Kompis M, Frahsa A, Waespe N, Ansari M, Kuehni CE. Evaluation of a New, Community-Based Screening Program to Detect Hearing Loss in Adult Childhood Cancer Survivors in Switzerland: Findings From the HEAR Study. Pediatr Blood Cancer. 2026 Jun;73(6):e70287. doi: 10.1002/1545-5017.70287. Epub 2026 Apr 6.
- Results publication: PubMed 40397950Jorger P, Nigg C, Mader L, Strebel S, Kompis M, Tomasikova Z, Schindera C, Michel G, von der Weid NX, Ansari M, Waespe N, Kuehni CE. A Health Service Research Study on a Low-Threshold Hearing Screening Program for Childhood Cancer Survivors in Switzerland: Protocol for the HEAR Study. JMIR Res Protoc. 2025 May 21;14:e63627. doi: 10.2196/63627.
- Study protocol (published)Link provided by the sponsor.
- Individual participant dataSharing planned: No
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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.
Claudia Kuehni, MD principal investigator
Institute of Social and Preventive Medicine, University of Bern
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Hearing test in people with Childhood Cancer and Hearing Loss, run by University of Bern at 1 site in Switzerland.
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 9 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 14 Apr 2026. 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 Switzerland. 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?
Reach: Number/proportion of written informed consents (time frame: 1 day after signed informed consent is sent back). The study lists 12 primary outcomes in all. 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 NCT06036407, which also lists 13 linked publications.
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 14 Apr 2026.