Screening for Hearing Loss After Childhood Cancer (HEAR)

University of Bern

Status: Completed

Conditions: Hearing Loss; Childhood Cancer

Treatments: Diagnostic Test: Hearing test

Study type: Interventional

Funder types: Other

Identifiers

NCT06036407

SCCSS_Ototox

Details and patient eligibility

About

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.

Full 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.

Enrollment: 476 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Screening

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

---

476 participants in 1 patient group

Participants

Experimental group

Description:

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.

Treatment:

Diagnostic Test: Hearing test