Breast Reconstruction, Breast Reconstruction After Mastectomy, Mastectomy, Mastectomy and Breast Reconstruction, Mastectomy Patient, Postmastectomy Pain
Conditions
Keywords
Postmastectomy Pain, breast reconstruction after mastectomy, breast reconstruction, mastectomy and breast reconstruction, mastectomy, mastectomy patient, 24-271, Memorial Sloan Kettering Cancer Center
Brief 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.
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
Sponsors
Memorial Sloan Kettering Cancer Center
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* 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 criteria
* Exchange or revision surgery within 6 months * Active medical reason for pain (e.g., infectious, neoplastic, wound related) * Greater than 15 years post-reconstruction
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of participants with Persistent Postmastectomy Pain | up to 6 months | The primary objective is to estimate the prevalence of Persistent Postmastectomy Pain/PPMP in breast cancer survivors treated with mastectomy and reconstruction. |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORDanielle Rochlin, MD
Memorial Sloan Kettering Cancer Center
Outcome results
None listed