Screening for Hearing Loss After Childhood Cancer

NCT06036407 | Completed

• 1 other identifier: SCCSS_Ototox
• Study Type: interventional
• Target: 476
• Locations: 1 country
• Sites: 1

Brief 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. The screening program will be evaluated using the RE-AIM framework.

Conditions

Childhood Cancer; Hearing Loss

Keywords

Ototoxicity; Late Effect; Ototoxic; Follow-up care; Screening

Outcome Measures

Primary Outcomes (12)

• 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.

  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.

  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.

  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.

  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.

  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).

  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.

  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.

  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.

  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.

  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.

  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

  Six months after participant conducted hearing test

Secondary Outcomes (2)

• Assessing hearing function in childhood cancer survivors

  Examinations (hearing tests) between July 2022 and July 2023

• Identify risk factors for hearing loss in CCS

  Hearing test results between July 2022 and July 2023

Study Arms (1)

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.

Diagnostic Test: Hearing test

Interventions

Hearing test DIAGNOSTIC_TEST

Participants visit a local hearing aid shop to assess their hearing function

Also known as: Hearing evaluation, Hearing assessment, Hearing screening

Participants

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• 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

You may not qualify if:

• Recently contacted for other studies (January 2022-July 2022)
• Not German/French speaking
• No postal address available

Sponsors & Collaborators

• University of Bern: lead
• Krebsforschung Schweiz, Bern, Switzerland: collaborator

Study Sites (1)

Institute for Social and Preventive Medicine

Bern, 3012, Switzerland

Location

Related Publications (13)

• 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.

  PMID: 27650356 BACKGROUND

• Clemens 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.

  PMID: 30614474 BACKGROUND

• Bass 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.

  PMID: 32729886 BACKGROUND

• Weiss 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.

  PMID: 30306534 BACKGROUND

• Khairi 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.

  PMID: 19913305 BACKGROUND

• Weiss 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.

  PMID: 29230928 BACKGROUND

• Babecoff 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.

  PMID: 35429234 BACKGROUND

• Michel 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.

  PMID: 20687196 BACKGROUND

• Michel 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.

  PMID: 27550385 BACKGROUND

• Jorger 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.

  PMID: 40179545 RESULT

• Jorger 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 Apr 6:e70287. doi: 10.1002/1545-5017.70287. Online ahead of print.

  PMID: 41943511 RESULT

• Jorger 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.

  PMID: 40397950 RESULT

• Jorger 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. doi: 10.1186/s12913-026-14491-5. Online ahead of print.

  PMID: 41965725 DERIVED

Related Links

• Study protocol (published)

MeSH Terms

Conditions

Neoplasms; Hearing Loss; Ototoxicity

Interventions

Hearing Tests

Condition Hierarchy (Ancestors)

Hearing Disorders; Ear Diseases; Otorhinolaryngologic Diseases; Sensation Disorders; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Pathologic Processes; Drug-Related Side Effects and Adverse Reactions; Chemically-Induced Disorders; Radiation Injuries; Wounds and Injuries

Intervention Hierarchy (Ancestors)

Diagnostic Techniques, Otological; Diagnostic Techniques and Procedures; Diagnosis

Study Officials

• Claudia Kuehni, MD

  Institute of Social and Preventive Medicine, University of Bern

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Masking Details: All participants undergo a hearing test (intervention).
• Purpose: SCREENING
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 28, 2023
• First Posted: September 13, 2023
• Study Start: July 5, 2022
• Primary Completion: July 15, 2023
• Study Completion: November 1, 2024
• Last Updated: April 14, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

CH (1)