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| ID | Type | Description | Link |
|---|---|---|---|
| 3114 | Other Grant/Funding Number | VA RR&D |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| COMP-VA | Experimental | Hearing testing at each treatment and at 1 month following treatment. |
|
| Usual Care | Experimental | Hearing testing done according to Audiology Clinic protocol |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| COMP-VA | Other | Hearing testing at each treatment interval by the comp-va audiologist |
| |
| Measure | Description | Time Frame |
|---|---|---|
| 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.
| 35 days post randomization |
| 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. | through study completion, an average of 1 year post randomization |
| Number of Participants With Mortality | Mortality among participants defined as differences in rates of death within one year of randomization. | 1 year post 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 | 1 year post randomization |
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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:
Criteria for excluding subjects (chemotherapy and controls subjects) from this study will be:
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| Name | Affiliation | Role |
|---|---|---|
| Dawn L Konrad-Martin, PhD | VA Portland Health Care System, Portland, OR | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| VA Portland Health Care System, Portland, OR | Portland | Oregon | 97239 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 28893111 | Background | 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. | |
| 26415968 | Background | 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. |
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Forty-seven Veterans receiving cisplatin for the treatment of cancer were randomized to one of the two treatment arms of the clinical trial. Thirty-six healthy participants were studied to assess normal variability in auditory function measures over time; they were not part of the clinical trial portion of this research project.
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| ID | Title | Description |
|---|---|---|
| FG000 | COMP-VA | Hearing testing at each treatment and at 1 month following treatment. COMP-VA: Hearing testing at each treatment interval by the comp-va audiologist |
| FG001 | Usual Care | Hearing testing done according to Audiology Clinic protocol Standard of care: Hearing testing done in the audiology clinic after oncology referral |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | COMP-VA | Hearing testing at each treatment and at 1 month following treatment. COMP-VA: Hearing testing at each treatment interval by the comp-va audiologist |
| BG001 | Usual Care |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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.
| Posted | Count of Participants | Participants | 35 days post randomization |
|
4 years
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | COMP-VA | Hearing testing at each treatment and at 1 month following treatment. COMP-VA: Hearing testing at each treatment interval by the comp-va audiologist |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Dawn Konrad-Martin | VA RR&D National Center for Rehabilitative Auditory Research | 503-220-8262 | 52962 | dawn.martin@va.gov |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Sep 29, 2017 | Aug 6, 2019 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Sep 29, 2017 | Aug 6, 2019 | SAP_001.pdf |
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| ID | Term |
|---|---|
| D034381 | Hearing Loss |
| D000081015 | Ototoxicity |
| ID | Term |
|---|---|
| D006311 | Hearing Disorders |
| D004427 | Ear Diseases |
| D010038 | Otorhinolaryngologic Diseases |
| D012678 | Sensation Disorders |
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| ID | Term |
|---|---|
| D059039 | Standard of Care |
| ID | Term |
|---|---|
| D019984 | Quality Indicators, Health Care |
| D011787 | Quality of Health Care |
| D006298 | Health Services Administration |
| D017530 | Health Care Quality, Access, and Evaluation |
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| Standard of care |
| Other |
Hearing testing done in the audiology clinic after oncology referral or patient self referral |
|
| 25985018 | Background | 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. |
| 29280917 | Background | 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. |
| 29157038 | Background | 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. |
| 28978238 | Background | 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. |
| 27518137 | Background | 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. |
| 24805896 | Background | 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. |
Hearing testing done according to Audiology Clinic protocol
Standard of care: Hearing testing done in the audiology clinic after oncology referral
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| 3, 4, and 6 kHz pure tone average (PTA) | Mean | Standard Deviation | dB HL |
|
| Usual Care |
Hearing testing done according to Audiology Clinic protocol Standard of care: Hearing testing done in the audiology clinic after oncology referral |
|
|
|
| Primary | 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. | All participants who received at least one dose of cisplatin and had at least two Program Evaluations. | Posted | Count of Participants | Participants | through study completion, an average of 1 year post randomization |
|
|
|
|
| Primary | Number of Participants With Mortality | Mortality among participants defined as differences in rates of death within one year of randomization. | Posted | Count of Participants | Participants | 1 year post randomization |
|
|
|
|
| Primary | 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 | Missing data on some participants due to loss of follow up. | Posted | Mean | Standard Deviation | score on a scale | 1 year post randomization |
|
|
|
|
| 2 |
| 24 |
| 0 |
| 24 |
| 0 |
| 24 |
| EG001 | Usual Care | Hearing testing done according to Audiology Clinic protocol Standard of care: Hearing testing done in the audiology clinic after oncology referral | 4 | 23 | 0 | 23 | 0 | 23 |
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| D009461 |
| Neurologic Manifestations |
| D009422 | Nervous System Diseases |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D010335 | Pathologic Processes |
| D064420 | Drug-Related Side Effects and Adverse Reactions |
| D064419 | Chemically-Induced Disorders |
| D011832 | Radiation Injuries |
| D014947 | Wounds and Injuries |