Head and Neck Cancer Survivorship Ototoxicity Screening (SOS)

NCT05789316 | Completed

• 1 other identifier: 202302038
• Study Type: interventional
• Target: 55
• Locations: 1 country
• Sites: 1

Brief Summary

To evaluate the effectiveness, feasibility, acceptability, and appropriateness of an ototoxicity screening protocol among head and neck (H\&N) cancer patients followed in survivorship clinic that received cisplatin-based chemoradiation therapy (CRT).

Conditions

Head and Neck Cancer Survivors; Cancer of the Head and Neck Surviors

Keywords

survivorship; quality of life; cisplatin; radiation; head and neck cancer; hearing loss; ototoxicity

Outcome Measures

Primary Outcomes (1)

• Rate of participants who complete audiologic follow-up

  Through completion of follow-up (estimated to be 6 months)

Secondary Outcomes (6)

• Feasibility of ototoxicity screening protocol as measured by the Feasibility of Intervention Measure

  Before survivorship clinic visit (Day 1)

• Acceptability of ototoxicity screening protocol as measured by the Acceptability of Intervention Measure

  Before survivorship clinic visit (Day 1)

• Appropriateness of ototoxicity screening protocol as measured by the Intervention Appropriateness Measure

  Before survivorship clinic visit (Day 1)

• Functional hearing loss of participants as measured by the Situational Management Questionnaire (SESMQ)

  After survivorship clinic visit (Day 1)

• Quality of life of participants as measured by the University of Washington Quality of Life Questionnaire (UW-QOL)

  After survivorship clinic visit (Day 1)

Study Arms (1)

Ototoxicity Screening Protocol

EXPERIMENTAL

After enrollment, participants will complete a pre-screening survey. Before their survivorship clinic visit, participants will complete the ototoxicity screening protocol and implementation outcome surveys. During their visit, they will receive counseling on ototoxicity and referral to audiology. After their visit, they will complete the SESMQ and WU-QOLv4 surveys and undergo pure tone audiometry. Each participant will complete this protocol once. The investigators will follow each participant by chart review for at least six months to evaluate for audiologic follow-up.

Other: Ototoxicity Screening Protocol

Interventions

Ototoxicity Screening Protocol OTHER

The ototoxicity screening protocol contains a functional and objective component. The functional component is the Hearing Handicap Inventory for the Elderly - Screening Version (HHIE-S). The objective component will be pure tone audiometry. A 2 kHz tone at 40 dB will play through over-the-ear headphones and subjects will indicate whether they heard it.

Ototoxicity Screening Protocol

Eligibility Criteria

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

You may qualify if:

• Adult (≥ 18 years old)

You may not qualify if:

• Patient has been evaluated by an audiologist within the past 12 months
• Use of a hearing aid
• Received a cochlear implant
• Cannot complete simple forms in English

Sponsors & Collaborators

• Washington University School of Medicine: lead
• American Academy of Otolaryngology-Head and Neck Surgery Foundation: collaborator

Study Sites (1)

Washington University School of Medicine

St Louis, Missouri, 63110, United States

Location

Related Links

• Alvin J. Siteman Cancer Center at Barnes-Jewish Hospital and Washington University School of Medicine

MeSH Terms

Conditions

Head and Neck Neoplasms; Hearing Loss; Ototoxicity

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; 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

Study Officials

• David Lee, M.D.

  Washington University School of Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 16, 2023
• First Posted: March 29, 2023
• Study Start: June 6, 2023
• Primary Completion: November 21, 2025
• Study Completion: November 21, 2025
• Last Updated: January 12, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)