Clinical trial · Interventional
Head and Neck Cancer Survivorship Ototoxicity Screening (SOS)
Head and Neck Cancer Survivorship Ototoxicity Screening (SOS) Protocol
NCT05789316CI-TRIAL-00100690completedN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Cancer of the Head and Neck Surviors | — | UNRESOLVED | — |
| Head and Neck Cancer Survivors | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Ototoxicity Screening Protocol | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Ototoxicity Screening Protocol
- description
- 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.
- interventionNames
- Other: Ototoxicity Screening Protocol
Primary outcomes (1)
- measure
- Rate of participants who complete audiologic follow-up
- timeFrame
- Through completion of follow-up (estimated to be 6 months)
Secondary outcomes (6)
- measure
- Feasibility of ototoxicity screening protocol as measured by the Feasibility of Intervention Measure
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available
No reference posted for this study.