An interventional study of Hearing test in Childhood Cancer and Hearing Loss, sponsored by University of Bern. Completed at 1 site in Switzerland. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-04-14.
Sponsored by University of Bern · Not applicable, Interventional, and Screening
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.
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.
10,818 studies on the registry are indexed under Neoplasms; 2,324 are open to participants now.
This study's enrollment of 476 is above the median of 60 across 7,703 interventional studies indexed under Neoplasms.
Browse Neoplasms studies →University of Bern is the lead sponsor of 209 studies on the registry; 47 are open to participants now.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Diagnostic Test: Hearing test
Participants visit a local hearing aid shop to assess their hearing function
Also known as: Hearing evaluation, Hearing assessment, Hearing screening
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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).
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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
Time frame: Six months after participant conducted hearing test
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.
Time frame: 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.
Time frame: Hearing test results between July 2022 and July 2023
Plan to share: No
Ran from Jul 2022 to primary completion in Jul 2023, 12 months.
Of 1,981 non-industry interventional studies with no phase under Neoplasms, half reached primary completion within 29 months of starting (the median), counting those still running; a quarter within 13 and three quarters within 52. This study's 12 months is below that.
Counting every sponsor, half of 2,056 studies reached it within 29 months; a quarter within 13 and three quarters within 52.
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This study is completed, as verified in Apr 2026. You cannot join it, but the record below documents what was studied.
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