Clinical trial NCT06036407: Screening for Hearing Loss After Childhood Cancer
Official title: Improving Access to Screening for Hearing Loss After Childhood Cancer - a Novel Community-based Approach
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Childhood Cancer
Hearing Loss
Keywords: Ototoxicity
Late Effect
Ototoxic
Follow-up care
Screening
Lead sponsor: University of Bern
Sponsor class: OTHER
Collaborators: name: Krebsforschung Schweiz, Bern, Switzerland
First posted: 2023-09-13
Enrollment: 476
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SCREENING

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.

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.

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

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

Primary outcomes:
measure: Reach: Number/proportion of written informed consents
timeFrame: 1 day after signed informed consent is sent back
measure: Reach: Number/proportion of participants that consented, who participated in screening program (i.e. completed hearing test)
timeFrame: 4 weeks after participant completed hearing test
measure: Reach: Comparing characteristics of (non-)responders
timeFrame: 1 day after signed informed consent is sent back
measure: Reach: Motives for participation
timeFrame: 3 months after participant completed hearing test
measure: Effectiveness: Number/proportion of participants with (newly) detected hearing loss
timeFrame: 4 weeks after participant completed hearing test
measure: Effectiveness: Number/proportion of participants with (newly) detected hearing loss who contacted their treating healthcare professional.
timeFrame: 6 months after participant completed hearing test
measure: Effectiveness: Other possible effects on mental health (newly detected hearing loss, reminded of disease)
timeFrame: 3 months after participant completed hearing test
measure: Adoption: Satisfaction, opinions and suggestions of participants and key stakeholders
timeFrame: 3 months after participant completed hearing test
measure: Adoption: Geographical distribution of hearing aid shops visited during the study
timeFrame: 4 weeks after participant completed hearing test
measure: Implementation: Fidelity and consistency to the intervention protocol.
timeFrame: Six months after hearing test
measure: Implementation: Estimated costs for implementation
timeFrame: Six months after hearing test
measure: Maintenance: Opinions of stakeholders and participants on the continuation of the screening program
timeFrame: Six months after participant conducted hearing test
Secondary outcomes:
measure: Assessing hearing function in childhood cancer survivors
timeFrame: Examinations (hearing tests) between July 2022 and July 2023
measure: Identify risk factors for hearing loss in CCS
timeFrame: Hearing test results between July 2022 and July 2023
Other outcomes:
Locations:
city: Bern
country: Switzerland
facility: Institute for Social and Preventive Medicine
Study officials:
affiliation: Institute of Social and Preventive Medicine, University of Bern
name: Claudia Kuehni, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
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citation: 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.
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