Screening for Hearing Loss After Childhood Cancer

Hearing Loss Clinical Trial

— HEAR  

Official title:

Improving Access to Screening for Hearing Loss After Childhood Cancer - a Novel Community-based Approach

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT06036407
• Other study ID #: SCCSS_Ototox
• Status: Active, not recruiting
• Phase: N/A
• Start date: July 5, 2022
• Est. completion date: June 1, 2024

Study information

• Verified date: May 2024
• Source: University of Bern
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

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

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 474
• Est. completion date: June 1, 2024
• Est. primary completion date: July 15, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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)

• Italian speaking

• No postal address available

Related Conditions & MeSH terms

• Childhood Cancer
• Deafness
• Hearing Loss

Intervention

Diagnostic Test:
• Hearing test
Participants visit a local hearing aid shop to assess their hearing function

Locations

Country	Name	City	State
Switzerland	Institute for Social and Preventive Medicine	Bern

Sponsors (2)

Lead Sponsor	Collaborator
University of Bern	Krebsforschung Schweiz, Bern, Switzerland

Country where clinical trial is conducted

Switzerland, 

References & Publications (9)

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. — View Citation

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. — View 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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View 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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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	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.	Examinations (hearing tests) between July 2022 and July 2023
Secondary	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.	Hearing test results between July 2022 and July 2023