Back to resultsHead and Neck Cancer Survivorship Ototoxicity Screening (SOS)
Primary Purpose
Head and Neck Cancer Survivors, Cancer of the Head and Neck Surviors
Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Ototoxicity Screening Protocol
Sponsored by
About this trial
This is an interventional supportive care trial for Head and Neck Cancer Survivors focused on measuring survivorship, quality of life, cisplatin, radiation, head and neck cancer, hearing loss, ototoxicity
Eligibility Criteria
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
Sites / Locations
- Washington University School of MedicineRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Ototoxicity Screening Protocol
Arm 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.
Outcomes
Primary Outcome Measures
Rate of participants who complete audiologic follow-up
Secondary Outcome Measures
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.
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.
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.
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.
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.
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.
Full Information
NCT ID
NCT05789316
First Posted
March 16, 2023
Last Updated
October 20, 2023
Sponsor
Washington University School of Medicine
Collaborators
American Academy of Otolaryngology-Head and Neck Surgery Foundation
1. Study Identification
Unique Protocol Identification Number
NCT05789316
Brief Title
Head and Neck Cancer Survivorship Ototoxicity Screening (SOS)
Official Title
Head and Neck Cancer Survivorship Ototoxicity Screening (SOS) Protocol
Study Type
Interventional
2. Study Status
Record Verification Date
October 2023
Overall Recruitment Status
Recruiting
Study Start Date
June 6, 2023 (Actual)
Primary Completion Date
December 31, 2024 (Anticipated)
Study Completion Date
December 31, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Washington University School of Medicine
Collaborators
American Academy of Otolaryngology-Head and Neck Surgery Foundation
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. 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).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Head and Neck Cancer Survivors, Cancer of the Head and Neck Surviors
Keywords
survivorship, quality of life, cisplatin, radiation, head and neck cancer, hearing loss, ototoxicity
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
60 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Ototoxicity Screening Protocol
Arm Type
Experimental
Arm 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.
Intervention Type
Other
Intervention Name(s)
Ototoxicity Screening Protocol
Intervention Description
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 Outcome Measure Information:
Title
Rate of participants who complete audiologic follow-up
Time Frame
Through completion of follow-up (estimated to be 6 months)
Secondary Outcome Measure Information:
Title
Feasibility of ototoxicity screening protocol as measured by the Feasibility of Intervention Measure
Description
-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)
Title
Acceptability of ototoxicity screening protocol as measured by the Acceptability of Intervention Measure
Description
-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)
Title
Appropriateness of ototoxicity screening protocol as measured by the Intervention Appropriateness Measure
Description
-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)
Title
Functional hearing loss of participants as measured by the Situational Management Questionnaire (SESMQ)
Description
-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)
Title
Quality of life of participants as measured by the University of Washington Quality of Life Questionnaire (UW-QOL)
Description
-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)
Title
Functional social support as measured by the Duke-UNC Functional Social Support Questionnaire
Description
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)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
David Lee, M.D.
Phone
314-935-5000
Email
david.s.lee@wustl.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
David Lee, M.D.
Organizational Affiliation
Washington University School of Medicine
Official's Role
Principal Investigator
Facility Information:
Facility Name
Washington University School of Medicine
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63110
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
David Lee, M.D.
Phone
314-935-5000
Email
david.s.lee@wustl.edu
First Name & Middle Initial & Last Name & Degree
David Lee, M.D.
First Name & Middle Initial & Last Name & Degree
Kate McClannahan, AuD, Ph.D.
First Name & Middle Initial & Last Name & Degree
Sidharth Puram, M.D., Ph.D.
First Name & Middle Initial & Last Name & Degree
Melissa Portell, PA-C
First Name & Middle Initial & Last Name & Degree
Cathryn Collopy, AuD
First Name & Middle Initial & Last Name & Degree
Emma Travis
First Name & Middle Initial & Last Name & Degree
Susan Wong
12. IPD Sharing Statement
Plan to Share IPD
No
Links:
URL
http://www.siteman.wustl.edu
Description
Alvin J. Siteman Cancer Center at Barnes-Jewish Hospital and Washington University School of Medicine
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Head and Neck Cancer Survivorship Ototoxicity Screening (SOS)
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