Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
500 participants
INTERVENTIONAL
2024-10-01
2027-10-01
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Postmastectomy Reconstruction Participants
Participants will be postmastectomy reconstruction and \>/= 6 months postoperative
PROMIS 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.
PROMIS 29+2
PROMIS 29+2 (PROMIS-Preference, PROPr) is a compilation of item banks to assess pain intensity
PROMIS Scale v2.0 - Nociceptive Pain Quality 5a
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
5-question short form that identifies patients who have experienced neuropathic pain during the past 7 days
Interventions
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PROMIS 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.
PROMIS 29+2
PROMIS 29+2 (PROMIS-Preference, PROPr) is a compilation of item banks to assess pain intensity
PROMIS Scale v2.0 - Nociceptive Pain Quality 5a
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
5-question short form that identifies patients who have experienced neuropathic pain during the past 7 days
Eligibility Criteria
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Inclusion Criteria
* 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
* Active medical reason for pain (e.g., infectious, neoplastic, wound related)
* Greater than 15 years post-reconstruction
18 Years
FEMALE
Yes
Sponsors
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Memorial Sloan Kettering Cancer Center
OTHER
Responsible Party
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Principal Investigators
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Danielle Rochlin, MD
Role: PRINCIPAL_INVESTIGATOR
Memorial Sloan Kettering Cancer Center
Locations
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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
Countries
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Central Contacts
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Facility Contacts
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Danielle Rochlin, MD
Role: primary
Danielle Rochlin, MD
Role: primary
Danielle Rochlin, MD
Role: primary
Danielle Rochlin, MD
Role: primary
Danielle Rochlin, MD
Role: primary
Danielle Rochlin, MD
Role: primary
Related Links
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Memorial Sloan Kettering Cancer Center
Other Identifiers
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24-271
Identifier Type: -
Identifier Source: org_study_id
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