Screening for Hearing Loss After Childhood Cancer (HEAR)

September 6, 2023 updated by: University of Bern

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.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Estimated)

474

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Switzerland
      • Bern, Switzerland, 3012
        • Institute for Social and Preventive Medicine

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Diagnosed with childhood cancer according to the international classification of childhood cancer, edition 3 (ICCC3) main groups
  • Diagnosed before the age 20
  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Screening
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Participants
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
Other Names:
  • Hearing evaluation
  • Hearing assessment
  • Hearing screening

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
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)
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.
4 weeks after participant completed hearing test
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.
1 day after signed informed consent is sent back
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.
3 months after participant completed hearing test
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.
4 weeks after participant completed hearing test
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).
6 months after participant completed hearing test
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.
3 months after participant completed hearing test
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.
3 months after participant completed hearing test
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.
4 weeks after participant completed hearing test
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.
Six months after hearing test
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.
Six months after hearing test
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
Six months after participant conducted hearing test

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Assessing hearing function in childhood cancer survivors
Time Frame: Examinations (hearing tests) between July 2022 and July 2023
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
Identify risk factors for hearing loss in CCS
Time Frame: Hearing test results between July 2022 and July 2023

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Bern

Collaborators

Krebsforschung Schweiz, Bern, Switzerland

Investigators

  • Principal Investigator: Claudia Kuehni, MD, Institute of Social and Preventive Medicine, University of Bern

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 5, 2022

Primary Completion (Actual)

July 15, 2023

Study Completion (Estimated)

March 1, 2024

Study Registration Dates

First Submitted

August 28, 2023

First Submitted That Met QC Criteria

September 6, 2023

First Posted (Actual)

September 13, 2023

Study Record Updates

Last Update Posted (Actual)

September 13, 2023

Last Update Submitted That Met QC Criteria

September 6, 2023

Last Verified

September 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SCCSS_Ototox

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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