An interventional study of Ototoxicity Screening Protocol in Head and Neck Cancer Survivors and Cancer of the Head and Neck Surviors, sponsored by Washington University School of Medicine. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-01-12.
Sponsored by Washington University School of Medicine · Not applicable, Interventional, and Supportive care
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).
2,710 studies on the registry are indexed under Head and Neck Neoplasms; 594 are open to participants now.
This study's enrollment of 55 is above the median of 46 across 2,032 interventional studies indexed under Head and Neck Neoplasms.
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Of its 329 completed or terminated interventional studies of FDA-regulated products, 216 (66%) have results posted.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Neoadjuvant treatment is given before the main treatment (usually surgery), often to shrink a tumour. Adjuvant treatment is given after it, to lower the chance of the cancer coming back.
Adjuvant and neoadjuvant
Neoadjuvant treatment is given before the main treatment (usually surgery), often to shrink a tumour. Adjuvant treatment is given after it, to lower the chance of the cancer coming back.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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
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.
Rate of participants who complete audiologic follow-up
Time frame: Through completion of follow-up (estimated to be 6 months)
Feasibility of ototoxicity screening protocol as measured by the Feasibility of Intervention Measure
-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.
Time frame: Before survivorship clinic visit (Day 1)
Acceptability of ototoxicity screening protocol as measured by the Acceptability of Intervention Measure
-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.
Time frame: Before survivorship clinic visit (Day 1)
Appropriateness of ototoxicity screening protocol as measured by the Intervention Appropriateness Measure
-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.
Time frame: Before survivorship clinic visit (Day 1)
Functional hearing loss of participants as measured by the Situational Management Questionnaire (SESMQ)
-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.
Time frame: After survivorship clinic visit (Day 1)
Quality of life of participants as measured by the University of Washington Quality of Life Questionnaire (UW-QOL)
-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.
Time frame: After survivorship clinic visit (Day 1)
Functional social support as measured by the Duke-UNC Functional Social Support Questionnaire
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.
Time frame: After survivorship clinic visit (Day 1)
Plan to share: No
This study is completed, as verified in Jan 2026. You cannot join it, but the record below documents what was studied.
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