RecruitingNot ApplicableNCT06627582

A Study on Pain After Breast Reconstruction

Persistent Postmastectomy Pain: Defining the Burden of Disease and the Role of Surgical Reinnervation in Patients With Breast Reconstruction


Sponsor

Memorial Sloan Kettering Cancer Center

Enrollment

500 participants

Start Date

Oct 1, 2024

Study Type

INTERVENTIONAL

Conditions

Summary

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.


Eligibility

Sex: FEMALEMin Age: 18 Years

Inclusion Criteria6

  • Female
  • Age ≥18 years
  • History of mastectomy for breast cancer or genetic predisposition to breast cancer
  • History of breast reconstruction with implants and/or autologous tissue
  • At least 6 months of follow-up after reconstruction
  • Patient treated at MSK

Exclusion Criteria3

  • Exchange or revision surgery within 6 months
  • Active medical reason for pain (e.g., infectious, neoplastic, wound related)
  • Greater than 15 years post-reconstruction

Interventions

BEHAVIORALPROMIS Scale v2.0 - Pain Intensity 3a

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.

BEHAVIORALPROMIS 29+2

PROMIS 29+2 (PROMIS-Preference, PROPr) is a compilation of item banks to assess pain intensity

BEHAVIORALPROMIS Scale v2.0 - Nociceptive Pain Quality 5a

5-question short form that identifies patients who have experienced nociceptive pain during the past 7 days

BEHAVIORALPROMIS Scale v2.0 - Neuropathic Pain Quality 5a

5-question short form that identifies patients who have experienced neuropathic pain during the past 7 days


Locations(7)

Memoral Sloan Kettering Basking Ridge (Limited Protocol Activities)

Basking Ridge, New Jersey, United States

Memoral Sloan Kettering Monmouth (Limited protocol activities)

Middletown, New Jersey, United States

Memorial Sloan Kettering Bergen (Limited Protocol Activities)

Montvale, New Jersey, United States

Memorial Sloan Kettering Suffolk-Commack (Limited protocol activity)

Commack, New York, United States

Memorial Sloan Kettering Westchester (Limited Protocol Activities)

Harrison, New York, United States

Memorial Sloan Kettering Cancer Center (All protocol activites)

New York, New York, United States

Memorial Sloan Kettering Nassau (Limited Protocol Activites)

Rockville Centre, New York, United States

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NCT06627582


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