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| Name | Class |
|---|---|
| Indiana Clinical and Translational Sciences Institute | OTHER |
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The purpose of this pilot study is to determine the safety and feasibility of a daily 3-minute hand-held vibration therapy intervention to reduce the severity of CIPN in the hands. The investigators hypothesize that daily vibration therapy can reduce the severity of patient's CIPN in their hands and improve CIPN-related quality of life. The hope is that results from this study will provide early data on the feasibility, efficacy, and most importantly, safety, of daily 3-minute hand-held vibration therapy needed to justify future clinical trials examining vibration therapy as a potential option for treating CIPN in the future.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Vibration Therapy | Experimental | Patients will hold a hand held vibrating device for 3 minutes on each hand daily for 4 weeks. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Vibration therapy | Device | vibration therapy using hand held vibration device |
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| Measure | Description | Time Frame |
|---|---|---|
| Feasibility of recruitment- percentage of patients who agree to participate in the study after screening | recruitment period (up to 5 year after study starts) | |
| Feasibility of compliance- percentage of vibration therapy sessions completed | Compliance with the daily vibration therapy sessions will be evaluated using data from a Daily Compliance Form Researchers will calculate the percentage of sessions that were completed calculated for each participant, on each hand. Participant compliance with the intervention will be considered acceptable if participants complete ≥ 80% of the sessions they were assigned. | 4 weeks |
| Acceptability of Intervention- percentage of patients who answer agree on acceptability form | percentage of participants who answer "somewhat agree," "agree," or "strongly agree" on the intervention acceptability form | 4 weeks |
| Change in the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Chemotherapy Induced Peripheral Neuropathy twenty-item scale (CIPN20) scores | CIPN 20 questionnaire scores will be compared to baseline weekly to identify an increase of 30% during the intervention period. The CIPN scores range from 20 to 80 with 80 being consistent with the most severe neuropathy symptoms | baseline, week 1, week 2, week 3, week 4 |
| Measure | Description | Time Frame |
|---|---|---|
| Change in CIPN Severity via the CIPN20 questionnaire scores | Summary statistics for the weekly CIPN-20 (n, mean, standard deviation, median, minimum, maximum) | baseline, weeks 1, 2, 3, and 4, 5, 6, 7, and week 8 |
| Change in CIPN related Quality of Life via the Chemotherapy Induced Peripheral Neuropathy Quality of Life Scale |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Cheri West, RN | Contact | 317-278-3021 | chawest@iu.edu | |
| Lacy Slayton | Contact | (317) 278-6718 | lslayton@iu.edu |
| Name | Affiliation | Role |
|---|---|---|
| Erin Newton, MD | Indiana University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Indiana University Health West | Recruiting | Avon | Indiana | 46123 | United States |
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| ID | Term |
|---|---|
| D009369 | Neoplasms |
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Subjects will be instructed to perform 3-minutes of vibration therapy per hand each day using a hand held vibration device for 4 weeks. The amount of time that subjects perform vibration therapy will be recorded on their Daily Compliance form and subjects will complete questionnaires daily and weekly.
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Descriptive statistics (frequency and percentage for each category, mean and standard deviation of scores assigned to each category (range: 0-7)) will be used to describe the CIPN-related QOL participants have on each of the three categories related to quality of life |
| baseline, week 4, week 8 |
| Indiana University Melvin & Bren Simon Cancer Center | Recruiting | Indianapolis | Indiana | 46202 | United States |
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| IU Health Joe & Shelly Schwarz Cancer Center | Recruiting | Indianapolis | Indiana | 46202 | United States |
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