Trial Title:
A Study on Pain After Breast Reconstruction
NCT ID:
NCT06627582
Condition:
Mastectomy
Mastectomy Patient
Mastectomy and Breast Reconstruction
Breast Reconstruction
Breast Reconstruction After Mastectomy
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
Study type:
Interventional
Study phase:
N/A
Overall status:
Recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Behavioral
Intervention name:
PROMIS Scale v2.0 - Pain Intensity 3a
Description:
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.
Arm group label:
Postmastectomy Reconstruction Participants
Intervention type:
Behavioral
Intervention name:
PROMIS 29+2
Description:
PROMIS 29+2 (PROMIS-Preference, PROPr) is a compilation of item banks to assess pain
intensity
Arm group label:
Postmastectomy Reconstruction Participants
Intervention type:
Behavioral
Intervention name:
PROMIS Scale v2.0 - Nociceptive Pain Quality 5a
Description:
5-question short form that identifies patients who have experienced nociceptive pain
during the past 7 days
Arm group label:
Postmastectomy Reconstruction Participants
Intervention type:
Behavioral
Intervention name:
PROMIS Scale v2.0 - Neuropathic Pain Quality 5a
Description:
5-question short form that identifies patients who have experienced neuropathic pain
during the past 7 days
Arm group label:
Postmastectomy Reconstruction Participants
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.
Criteria for eligibility:
Criteria:
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
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
Gender:
Female
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
Accepts Healthy Volunteers
Locations:
Facility:
Name:
Memoral Sloan Kettering Basking Ridge (Limited Protocol Activities)
Address:
City:
Basking Ridge
Zip:
07920
Country:
United States
Status:
Recruiting
Contact:
Last name:
Danielle Rochlin, MD
Phone:
646-608-8033
Email:
rochlind@mskcc.org
Facility:
Name:
Memoral Sloan Kettering Monmouth (Limited protocol activities)
Address:
City:
Middletown
Zip:
07748
Country:
United States
Status:
Recruiting
Contact:
Last name:
Danielle Rochlin, MD
Phone:
646-608-8033
Facility:
Name:
Memorial Sloan Kettering Bergen (Limited Protocol Activities)
Address:
City:
Montvale
Zip:
07645
Country:
United States
Status:
Recruiting
Contact:
Last name:
Danielle Rochlin, MD
Phone:
646-608-8033
Facility:
Name:
Memorial Sloan Kettering Suffolk-Commack (Limited protocol activity)
Address:
City:
Commack
Zip:
11725
Country:
United States
Status:
Recruiting
Contact:
Last name:
Danielle Rochlin, MD
Phone:
646-608-8033
Facility:
Name:
Memorial Sloan Kettering Westchester (Limited Protocol Activities)
Address:
City:
Harrison
Zip:
10604
Country:
United States
Status:
Recruiting
Contact:
Last name:
Danielle Rochlin, MD
Phone:
646-608-8033
Facility:
Name:
Memorial Sloan Kettering Cancer Center (All protocol activites)
Address:
City:
New York
Zip:
10065
Country:
United States
Status:
Recruiting
Contact:
Last name:
Danielle Rochlin, MD
Phone:
646-608-8033
Facility:
Name:
Memorial Sloan Kettering Nassau (Limited Protocol Activites)
Address:
City:
Rockville Centre
Zip:
11553
Country:
United States
Status:
Recruiting
Contact:
Last name:
Danielle Rochlin, MD
Phone:
646-608-8033
Start date:
October 1, 2024
Completion date:
October 1, 2027
Lead sponsor:
Agency:
Memorial Sloan Kettering Cancer Center
Agency class:
Other
Source:
Memorial Sloan Kettering Cancer Center
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06627582
http://www.mskcc.org
