Randomized Trial Comparison of Ototoxicity Monitoring Programs (COMP-VA)
Primary Purpose
Cisplatin Ototoxicity, Hearing Loss
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
COMP-VA
Standard of care
Sponsored by
About this trial
This is an interventional prevention trial for Cisplatin Ototoxicity focused on measuring hearing, cisplatin, Ototoxicity, Veterans
Eligibility Criteria
Inclusion Criteria:
All Veterans entering cisplatin chemotherapy will be informed of the project and invited to participate unless the Veteran was excluded by CPRS review or medical advice.
Exclusion Criteria:
- Experimental subjects must be prescribed cisplatin for treatment of cancer to be enrolled in the treatment arms of this study.
Criteria for excluding subjects (chemotherapy and controls subjects) from this study will be:
- cognitively or physically unable to participate (patient or nurse report patient is incapable of participating), CPRS indication that subject exhibits aggressive behavior, subject has documented dementia, Alzheimer's disease, or severe psychosocial disorder, CPRS notes indicate individual is not legally capable of providing informed consent (subject has a legal guardian)
- unable to provide reliable behavioral hearing test responses (for either program evaluation hearing test or baseline, pre -treatment hearing test) as indicated by intra-session behavioral threshold reliability criterion of > +5 dB)
- exhibits Meniere's disease or retrocochlear disorder based on hearing test results, patient report or notes in CPRS
- exhibits active or recent history of middle ear disorder based on otoscopy, tympanometry, patient report, or notes in CPRS
- unwilling to participate
- hearing thresholds > 70 dB SPL at 4 kHz and below (based on DPOAE 'no response' data from a similar protocol described in Bibliography Reference 32, Table 3). The last exclusion was adopted in an effort to increase the potential that DPOAEs will be measurable in a large number of subjects.
Sites / Locations
- VA Portland Health Care System, Portland, OR
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
COMP-VA
Usual Care
Arm Description
Hearing testing at each treatment and at 1 month following treatment.
Hearing testing done according to Audiology Clinic protocol
Outcomes
Primary Outcome Measures
Number of Participants With an Ototoxic Hearing Shift
Veterans randomized to the COMP-VA arm will have improved hearing outcomes (a) fewer ASHA-significant threshold shifts, (b) fewer CTCAE grade 1 or greater hearing shifts at Program Evaluation 3 as compared with Veterans randomized to the Usual Care arm.
ASHA Shift is defined as:
20 dB shift at a single frequency 10 dB shift at two adjacent frequencies loss of response at three adjacent frequencies
CTCAE Grade 1 or greater ototoxicity = hearing shift of 15-25 dB averaged at 2 contiguous test frequencies
Number of Participants Who Accessed the Audiology Clinic for Aural Rehabilitation
Veterans randomized to Comp-VA will access and use audiology rehabilitation at higher rates than usual care up to 1 year post-treatment. This includes: New hearing aid issued; Hearing aid adjustments made; Technology updated.
Number of Participants With Mortality
Mortality among participants defined as differences in rates of death within one year of randomization.
Hearing-related Quality of Life Measure
Differences in the Hearing Handicap Inventory for Adults (HHIA) questionnaire score [or Hearing Handicap Inventory for the Elderly (HHIE) score as appropriate] depending on the age of the subject.
Minimum possible value = 0 Maximum possible value = 100 A higher score indicates poorer performance
Secondary Outcome Measures
Full Information
NCT ID
NCT02099786
First Posted
February 26, 2014
Last Updated
September 17, 2019
Sponsor
VA Office of Research and Development
1. Study Identification
Unique Protocol Identification Number
NCT02099786
Brief Title
Randomized Trial Comparison of Ototoxicity Monitoring Programs
Acronym
COMP-VA
Official Title
Comprehensive Ototoxicity Monitoring Program for VA: A Randomized Trial
Study Type
Interventional
2. Study Status
Record Verification Date
September 2019
Overall Recruitment Status
Completed
Study Start Date
April 1, 2015 (Actual)
Primary Completion Date
May 5, 2018 (Actual)
Study Completion Date
May 5, 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
VA Office of Research and Development
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
This study involves research. Some chemotherapeutic drugs that can permanently reduce hearing are termed "ototoxic". One such drug is the chemotherapy called cisplatin. Currently, if a patient is receiving cisplatin, hearing is tested in the Audiology Clinic using lengthy protocols and may be retested only when it is requested by their oncologist and when the Veteran can arrange an appointment. Researchers think that hearing testing prior to every treatment of cisplatin may reduce the number of Veterans who get disabling hearing loss from treatment. The purpose of this study is to compare the current method of monitoring hearing (audiology clinic protocols termed "usual care") with a new portable hearing monitoring program (a comprehensive program of ototoxicity monitoring termed "COMP-VA") that tests hearing using a portable hearing testing audiometer and a variety of efficient tools and techniques so that testing can occur prior to each cisplatin treatment at any quiet location in the hospital.
Detailed Description
Research objectives are to compare the effectiveness of ototoxicity monitoring implemented using Comp-VA or usual care with regard to (1) improving Veterans' hearing and quality of life outcomes, (2) assisting oncologists in pre-treatment counseling and therapeutic planning and (3) increasing use of post-treatment rehabilitative services.
The investigators plan to recruit a total of 320 Veterans undergoing cisplatin chemotherapeutic treatment over 4 years and 120 control subjects.
Program Evaluation: Hearing testing prior to treatment will be done in order to establish eligibility, enroll and randomize each subject into one of two study arms. At 5 weeks and at one year post-randomization hearing will be re-tested in order to obtain an estimate of longitudinal trends in hearing and quality of life assessment. Use of audiological services following treatment from the randomized subjects will be tracked. Finally, data will also be collected at each treatment interval to track use of counseling tools and oncology personnel treatment decisions.
Serial measurements from subjects receiving cisplatin prior to treatment who are randomized to:
Comp-VA group will get a screening hearing test prior to treatment, at each treatment interval and at one-month post-treatment. Auditory testing will be done on or near the Chemo Unit and will include otoscopy, immittance testing, and a hearing testing done by the Veteran using a self-testing procedure, and may be tested using distortion product otoacoustic emissions (DPOAEs), if they cannot take a reliable hearing test.
Usual care group will receive a full audiometric evaluation (otoscopy, immittance testing, air conduction and bone conduction hearing testing, speech audiometry, and distortion product otoacoustic emissions, DPOAEs) scheduled in the audiology clinic sound booth according to Audiology Service ototoxicity monitoring protocols. Testing will be arranged according to availability of appointments and patient convenience.
Additionally data will also be collected from control subjects who are similar in age and are tested at intervals similar to the chemotherapy subjects.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cisplatin Ototoxicity, Hearing Loss
Keywords
hearing, cisplatin, Ototoxicity, Veterans
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
47 (Actual)
8. Arms, Groups, and Interventions
Arm Title
COMP-VA
Arm Type
Experimental
Arm Description
Hearing testing at each treatment and at 1 month following treatment.
Arm Title
Usual Care
Arm Type
Experimental
Arm Description
Hearing testing done according to Audiology Clinic protocol
Intervention Type
Other
Intervention Name(s)
COMP-VA
Intervention Description
Hearing testing at each treatment interval by the comp-va audiologist
Intervention Type
Other
Intervention Name(s)
Standard of care
Intervention Description
Hearing testing done in the audiology clinic after oncology referral or patient self referral
Primary Outcome Measure Information:
Title
Number of Participants With an Ototoxic Hearing Shift
Description
Veterans randomized to the COMP-VA arm will have improved hearing outcomes (a) fewer ASHA-significant threshold shifts, (b) fewer CTCAE grade 1 or greater hearing shifts at Program Evaluation 3 as compared with Veterans randomized to the Usual Care arm.
ASHA Shift is defined as:
20 dB shift at a single frequency 10 dB shift at two adjacent frequencies loss of response at three adjacent frequencies
CTCAE Grade 1 or greater ototoxicity = hearing shift of 15-25 dB averaged at 2 contiguous test frequencies
Time Frame
35 days post randomization
Title
Number of Participants Who Accessed the Audiology Clinic for Aural Rehabilitation
Description
Veterans randomized to Comp-VA will access and use audiology rehabilitation at higher rates than usual care up to 1 year post-treatment. This includes: New hearing aid issued; Hearing aid adjustments made; Technology updated.
Time Frame
through study completion, an average of 1 year post randomization
Title
Number of Participants With Mortality
Description
Mortality among participants defined as differences in rates of death within one year of randomization.
Time Frame
1 year post randomization
Title
Hearing-related Quality of Life Measure
Description
Differences in the Hearing Handicap Inventory for Adults (HHIA) questionnaire score [or Hearing Handicap Inventory for the Elderly (HHIE) score as appropriate] depending on the age of the subject.
Minimum possible value = 0 Maximum possible value = 100 A higher score indicates poorer performance
Time Frame
1 year post randomization
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
All Veterans entering cisplatin chemotherapy will be informed of the project and invited to participate unless the Veteran was excluded by CPRS review or medical advice.
Exclusion Criteria:
Experimental subjects must be prescribed cisplatin for treatment of cancer to be enrolled in the treatment arms of this study.
Criteria for excluding subjects (chemotherapy and controls subjects) from this study will be:
cognitively or physically unable to participate (patient or nurse report patient is incapable of participating), CPRS indication that subject exhibits aggressive behavior, subject has documented dementia, Alzheimer's disease, or severe psychosocial disorder, CPRS notes indicate individual is not legally capable of providing informed consent (subject has a legal guardian)
unable to provide reliable behavioral hearing test responses (for either program evaluation hearing test or baseline, pre -treatment hearing test) as indicated by intra-session behavioral threshold reliability criterion of > +5 dB)
exhibits Meniere's disease or retrocochlear disorder based on hearing test results, patient report or notes in CPRS
exhibits active or recent history of middle ear disorder based on otoscopy, tympanometry, patient report, or notes in CPRS
unwilling to participate
hearing thresholds > 70 dB SPL at 4 kHz and below (based on DPOAE 'no response' data from a similar protocol described in Bibliography Reference 32, Table 3). The last exclusion was adopted in an effort to increase the potential that DPOAEs will be measurable in a large number of subjects.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Dawn L Konrad-Martin, PhD
Organizational Affiliation
VA Portland Health Care System, Portland, OR
Official's Role
Principal Investigator
Facility Information:
Facility Name
VA Portland Health Care System, Portland, OR
City
Portland
State/Province
Oregon
ZIP/Postal Code
97239
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
28893111
Citation
Brungart D, Schurman J, Konrad-Martin D, Watts K, Buckey J, Clavier O, Jacobs PG, Gordon S, Dille MF. Using tablet-based technology to deliver time-efficient ototoxicity monitoring. Int J Audiol. 2018 Sep;57(sup4):S25-S33. doi: 10.1080/14992027.2017.1370138. Epub 2017 Sep 12.
Results Reference
background
PubMed Identifier
26415968
Citation
Dille MF, McMillan GP, Helt WJ, Konrad-Martin D, Jacobs P. A Store-and-Forward Tele-Audiology Solution to Promote Efficient Screenings for Ototoxicity during Cisplatin Cancer Treatment. J Am Acad Audiol. 2015 Oct;26(9):750-60. doi: 10.3766/jaaa.15028.
Results Reference
background
PubMed Identifier
25985018
Citation
Reavis KM, McMillan GP, Dille MF, Konrad-Martin D. Meta-Analysis of Distortion Product Otoacoustic Emission Retest Variability for Serial Monitoring of Cochlear Function in Adults. Ear Hear. 2015 Sep-Oct;36(5):e251-60. doi: 10.1097/AUD.0000000000000176.
Results Reference
background
PubMed Identifier
29280917
Citation
Konrad-Martin D, Knight K, McMillan GP, Dreisbach LE, Nelson E, Dille M. Long-Term Variability of Distortion-Product Otoacoustic Emissions in Infants and Children and Its Relation to Pediatric Ototoxicity Monitoring. Ear Hear. 2020 Mar/Apr;41(2):239-253. doi: 10.1097/AUD.0000000000000536.
Results Reference
background
PubMed Identifier
29157038
Citation
Konrad-Martin D, Poling GL, Garinis AC, Ortiz CE, Hopper J, O'Connell Bennett K, Dille MF. Applying U.S. national guidelines for ototoxicity monitoring in adult patients: perspectives on patient populations, service gaps, barriers and solutions. Int J Audiol. 2018 Sep;57(sup4):S3-S18. doi: 10.1080/14992027.2017.1398421. Epub 2017 Nov 20. Erratum In: Int J Audiol. 2018 Sep;57(sup4):S108.
Results Reference
background
PubMed Identifier
28978238
Citation
Garinis AC, Cornell A, Allada G, Fennelly KP, Maggiore RJ, Konrad-Martin D. Ototoxicity monitoring through the eyes of the treating physician: Perspectives from pulmonology and medical oncology. Int J Audiol. 2018 Sep;57(sup4):S19-S24. doi: 10.1080/14992027.2017.1381769. Epub 2017 Oct 5.
Results Reference
background
PubMed Identifier
27518137
Citation
Konrad-Martin D, Poling GL, Dreisbach LE, Reavis KM, McMillan GP, Lapsley Miller JA, Marshall L. Serial Monitoring of Otoacoustic Emissions in Clinical Trials. Otol Neurotol. 2016 Sep;37(8):e286-94. doi: 10.1097/MAO.0000000000001134.
Results Reference
background
PubMed Identifier
24805896
Citation
Konrad-Martin D, Reavis KM, McMillan G, Helt WJ, Dille M. Proposed comprehensive ototoxicity monitoring program for VA healthcare (COMP-VA). J Rehabil Res Dev. 2014;51(1):81-100. doi: 10.1682/JRRD.2013.04.0092.
Results Reference
background
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Randomized Trial Comparison of Ototoxicity Monitoring Programs
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