Head and Neck Cancer Survivorship Ototoxicity Screening (SOS)

Sponsor

Washington University School of Medicine (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05789316

Collaborator

(none)

Enrollment

Location

Arm

18.1

Anticipated Duration (Months)

3.9

Patients Per Site Per Month

Study Details

Study Description

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).

Condition or Disease	Intervention/Treatment	Phase
Head and Neck Cancer Survivors Cancer of the Head and Neck Surviors	Other: Ototoxicity Screening Protocol	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

70 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Supportive Care

Official Title:

Head and Neck Cancer Survivorship Ototoxicity Screening (SOS) Protocol

Anticipated Study Start Date :

Apr 30, 2023

Anticipated Primary Completion Date :

Oct 31, 2024

Anticipated Study Completion Date :

Oct 31, 2024

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 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 (0.25 - 8 kHz). Each participants 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.

Arm

Intervention/Treatment

Experimental: 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 (0.25 - 8 kHz). Each participants 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.

Outcome Measures

Primary Outcome Measures

Rate of participants who complete audiologic follow-up [Through completion of follow-up (estimated to be 6 months)]

Secondary Outcome Measures

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.
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.
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.
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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Adult (≥ 18 years old)
H&N cancer patients will be eligible for inclusion if they have previously undergone cisplatin-based CRT with curative intent (i.e., definitive, neoadjuvant, or adjuvant).