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

Mastectomy Breast Reconstruction Breast Reconstruction After Mastectomy Mastectomy Patient Mastectomy and Breast Reconstruction Postmastectomy Pain

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

Plain Language Summary

Simplified for easier understanding

This study investigates chronic pain experienced by women after breast reconstruction surgery following mastectomy (breast removal for cancer or genetic risk). Researchers at Memorial Sloan Kettering want to understand what factors contribute to ongoing pain in this population. **You may be eligible if...** - You are a woman aged 18 or older - You had a mastectomy for breast cancer or due to a genetic predisposition (e.g., BRCA mutation) - You have had breast reconstruction using implants and/or your own body tissue - It has been at least 6 months since your reconstruction - You were treated at Memorial Sloan Kettering Cancer Center **You may NOT be eligible if...** - You have had revision or exchange surgery within the past 6 months - You have an active medical cause for your pain (infection, wound issues, or cancer recurrence) - It has been more than 15 years since your reconstruction Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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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