Head and Neck Cancer Survivorship Ototoxicity Screening (SOS)

Not Applicable

Recruiting

• Conditions: Head and Neck Cancer Survivors; Cancer of the Head and Neck Surviors
• Interventions: Other: Ototoxicity Screening Protocol

• Registration Number: NCT05789316
• Lead Sponsor: Washington University School of Medicine

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).

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2023-03-16
• Study First Submitted QC: 2023-03-16
• Study First Posted: 2023-03-29
• Study Start: 2023-06-06
• Status Verified: 2024-10
• Last Update Submitted: 2024-10-21
• Last Update Posted: 2024-10-22
• Primary Completion: 2024-12-31
• Study Completion: 2024-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 60

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.

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Ototoxicity Screening Protocol	Ototoxicity Screening Protocol	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.

Primary Outcome Measures

Name	Time	Method
Rate of participants who complete audiologic follow-up	Through completion of follow-up (estimated to be 6 months)

Secondary Outcome Measures

Name	Time	Method
Feasibility of ototoxicity screening protocol as measured by the Feasibility of Intervention Measure	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.
Functional hearing loss of participants as measured by the Situational Management Questionnaire (SESMQ)	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.
Acceptability of ototoxicity screening protocol as measured by the Acceptability of Intervention Measure	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.
Appropriateness of ototoxicity screening protocol as measured by the Intervention Appropriateness Measure	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.
Quality of life of participants as measured by the University of Washington Quality of Life Questionnaire (UW-QOL)	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.
Functional social support as measured by the Duke-UNC Functional Social Support Questionnaire	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.

Trial Locations

Locations (1)

Washington University School of Medicine; 🇺🇸 Saint Louis, Missouri, United States