Skip to main content
OpenTrials
Completed

NCT Number: NCT05789316

Head and Neck Cancer Survivorship Ototoxicity Screening (SOS)

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).

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Head and Neck Cancer Survivors Cancer of the Head and Neck Surviors Chemically-Induced Disorders Drug-Related Side Effects and Adverse Reactions Ear Diseases Head and Neck Neoplasms Hearing Disorders Hearing Loss Neoplasms Neoplasms by Site Nervous System Diseases Neurologic Manifestations Otorhinolaryngologic Diseases Ototoxicity Pathologic Processes Pathological Conditions, Signs and Symptoms Radiation Injuries Sensation Disorders Signs and Symptoms Wounds and Injuries

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Washington University School of Medicine

St Louis, Missouri, 63110, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Adult (≥ 18 years old)
  • H&N cancer patients will be eligible for inclusion if they have previously undergone cisplatin-based CRT or radiotherapy, including proton therapy, intensity-modulated radiation therapy, and adaptive radiotherapy-surgery with curative intent (i.e., definitive, neoadjuvant, or adjuvant) or definitive surgery with neoadjuvant or adjuvant radiation.

Exclusion criteria

  • 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

Treatment and study plan

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.

Primary outcomes

  1. Rate of participants who complete audiologic follow-up

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

Secondary outcomes

  1. Feasibility of ototoxicity screening protocol as measured by the Feasibility of Intervention Measure

    Time frame: Before survivorship clinic visit (Day 1)

    -Contains 4 statements about the proposed intervention that are scored on a five-point Likert scale (1 indicates the participant "completely disagrees", 5 indicates "completely agrees"). A score greater than or equal to 4 will indicate the intervention is feasible.

  2. Acceptability of ototoxicity screening protocol as measured by the Acceptability of Intervention Measure

    Time frame: Before survivorship clinic visit (Day 1)

    -Contains 4 statements about the proposed intervention that are scored on a five-point Likert scale (1 indicates the participant "completely disagrees", 5 indicates "completely agrees"). A score greater than or equal to 4 will indicate the intervention is acceptable.

  3. Appropriateness of ototoxicity screening protocol as measured by the Intervention Appropriateness Measure

    Time frame: Before survivorship clinic visit (Day 1)

    -Contains 4 statements about the proposed intervention that are scored on a five-point Likert scale (1 indicates the participant "completely disagrees", 5 indicates "completely agrees"). A score greater than or equal to 4 will indicate the intervention is appropriate.

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

    Time frame: After survivorship clinic visit (Day 1)

    -This questionnaire contains 20 situations. Participants rate each situation according to their ability to hear in the given situation (hearing ability scale; SESMQH) and their confidence in managing the given situation (confidence scale; SESMQC). The score for each situation ranges from 0 (poor hearing/low confidence) to 10 (normal hearing/high confidence), totaling 200 points for each scale. The higher the score indicates less hearing loss to the participant.

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

    Time frame: After survivorship clinic visit (Day 1)

    -This questionnaire contains 16 items on morbidities associated with H&N cancer treatment. Twelve items are graded on a 5-point Likert scale. One question lists treatment-related morbidities and ask participants to identify their top three most important issues. The last three questions evaluate global QoL. It is scored on a scale from 0 (worst) to 100 (best). However, UW-QOL does not include symptoms of ototoxicity. Therefore, the investigators will modify it to include tinnitus and hearing loss as additional 5-point Likert scale questions and morbidities in the rank order question.

  6. Functional social support as measured by the Duke-UNC Functional Social Support Questionnaire

    Time frame: After survivorship clinic visit (Day 1)

    It has been validated for use in populations of cancer patients and cancer survivors. 5 questions are presented using a Likert scale from 0-2, with higher scores indicating a higher level of social support.

Sponsors and collaborators

Lead sponsor

Washington University School of Medicine

Other

Collaborators

  • American Academy of Otolaryngology-Head and Neck Surgery Foundation

Registry information

Official study title

Head and Neck Cancer Survivorship Ototoxicity Screening (SOS) Protocol

Important dates

Study start
2023
Primary completion
2025
Study completion
2025
First posted
Mar 29, 2023
Registry last updated
Jan 12, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.