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The are doing this study to find out whether using topical (on the skin) herbal plasters, Tibetree pain- relieving plasters (PRPs), can be an effective addition to standard opioid therapy for pain management. The researchers will look at whether the Tibetree PRPs are a practical (feasible) and effective way of managing localized pain (pain that is limited to a certain area) in people who are currently taking opioids. Participants in this study will have cancer or have had it in the past.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Topical herbal plaster | Experimental | Will use the Tibetree PRPs on Days 1-7 of the treatment period. |
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| Waitlist control group (WLC) | Active Comparator | Will use the Tibetree PRPs on Days 8-14 of the treatment period after a 7-day waiting period |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Topical herbal plaster | Drug | Participants will receive topical herbal plaster once a day for up to 8 hours daily for 7 days. |
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| Measure | Description | Time Frame |
|---|---|---|
| Enrollment rate | This is the proportion of patients who enroll in the study among those who are eligible and offered participation. | 2 years |
| Treatment adherence rate | The treatment adherence rate is defined as the proportion of patients who are in the intervention period (both arms) who complete at least 5 of the 7 days of herbal plaster application. | 2 years |
| Assessment completion rates | The proportion of randomized patients who complete the patient-reported assessments. | 2 years |
| Treatment satisfaction | will be measured on Day 7 of the intervention period. Satisfaction will be measured using two questions with five-point Likert-type response scales to assess overall satisfaction with integrating the patch into their opioid pain management plan and their willingness to recommend it to other patients. Patients will be considered "satisfied" with the treatment if they respond as "Satisfied" or "Very satisfied" to the satisfaction item | day 7 |
| Measure | Description | Time Frame |
|---|---|---|
| pain severity | The Brief Pain Inventory (BPI) will be used to quantify pain severity. The BPI contains 4 pain severity items and 7 pain interference items, all rated on a scale from 0 to 10 (higher ratings indicate worse pain intensity/interference) | up to day 7 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Jun Mao, MD, MSCE | Contact | 646-888-0863 | maoj@mskcc.org | |
| Kevin Liou, MD | Contact | 646-608-8563 |
| Name | Affiliation | Role |
|---|---|---|
| Jun Mao, MD, MSCE | Memorial Sloan Kettering Cancer Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Memorial Sloan Kettering Basking Ridge (All Protocol Activities) | Recruiting | Basking Ridge | New Jersey | 07920 | United States |
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| Label | URL |
|---|---|
| Memorial Sloan Kettering Cancer Center | View source |
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Memorial Sloan Kettering Cancer Center supports the international committee of medical journal editors (ICMJE) and the ethical obligation of responsible sharing of data from clinical trials. The protocol summary, a statistical summary, and informed consent form will be made available on clinicaltrials.gov when required as a condition of Federal awards, other agreements supporting the research and/or as otherwise required. Requests for deidentified individual participant data can be made beginning 12 months after publication and for up to 36 months post publication. Deidentified individual participant data reported in the manuscript will be shared under the terms of a Data Use Agreement and may only be used for approved proposals. Requests may be made to: crdatashare@mskcc.org.
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This is a single center, two-arm, randomized trial.
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| Memorial Sloan Kettering Monmouth (All Protocol Activities) | Recruiting | Middletown | New Jersey | 07748 | United States |
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| Memorial Sloan Kettering Bergen (All Protocol Activities) | Recruiting | Montvale | New Jersey | 07645 | United States |
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| Memorial Sloan Kettering Suffolk- Commack (All Protocol Activities) | Recruiting | Commack | New York | 11725 | United States |
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| Memorial Sloan Kettering Westchester (All Protocol Activities) | Recruiting | Harrison | New York | 10604 | United States |
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| Memorial Sloan Kettering Cancer Center (All Protocol Activities) | Recruiting | New York | New York | 10065 | United States |
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| Memorial Sloan Kettering Nassau (All Protocol Activities) | Recruiting | Rockville Centre | New York | 11553 | United States |
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| ID | Term |
|---|---|
| D000072716 | Cancer Pain |
| D009369 | Neoplasms |
| D010146 | Pain |
| ID | Term |
|---|---|
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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