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The purpose of this study is to find out how common persistent postmastectomy pain (PPMP) is among people who have had a mastectomy and breast reconstruction surgery for their breast cancer. The study will also look at how effective regenerative peripheral nerve interface (RPNI) surgery is for reducing pain from neuropathic PPMP after breast reconstruction.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Postmastectomy Reconstruction Participants | Experimental | Participants will be postmastectomy reconstruction and >/= 6 months postoperative |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| PROMIS Scale v2.0 - Pain Intensity 3a | Behavioral | PROMIS Scale v2.0 - Pain Intensity 3a is a 3-question short form in which patients rate their worst, average, and current level of pain during the past 7 days. |
| Measure | Description | Time Frame |
|---|---|---|
| Number of participants with Persistent Postmastectomy Pain | The primary objective is to estimate the prevalence of Persistent Postmastectomy Pain/PPMP in breast cancer survivors treated with mastectomy and reconstruction. | up to 6 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Danielle Rochlin, MD | Memorial Sloan Kettering Cancer Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Memoral Sloan Kettering Basking Ridge (Limited Protocol Activities) | 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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| PROMIS 29+2 | Behavioral | PROMIS 29+2 (PROMIS-Preference, PROPr) is a compilation of item banks to assess pain intensity |
|
| PROMIS Scale v2.0 - Nociceptive Pain Quality 5a | Behavioral | 5-question short form that identifies patients who have experienced nociceptive pain during the past 7 days |
|
| PROMIS Scale v2.0 - Neuropathic Pain Quality 5a | Behavioral | 5-question short form that identifies patients who have experienced neuropathic pain during the past 7 days |
|
| Memoral Sloan Kettering Monmouth (Limited protocol activities) |
| Middletown |
| New Jersey |
| 07748 |
| United States |
| Memorial Sloan Kettering Bergen (Limited Protocol Activities) | Montvale | New Jersey | 07645 | United States |
| Memorial Sloan Kettering Suffolk-Commack (Limited protocol activity) | Commack | New York | 11725 | United States |
| Memorial Sloan Kettering Westchester (Limited Protocol Activities) | Harrison | New York | 10604 | United States |
| Memorial Sloan Kettering Cancer Center (All protocol activites) | New York | New York | 10065 | United States |
| Memorial Sloan Kettering Nassau (Limited Protocol Activites) | Rockville Centre | New York | 11553 | United States |