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Prediction of Persistent Post-Mastectomy Pain

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT02329574
Recruitment Status : Unknown
Verified July 2017 by Kristin Schreiber, Brigham and Women's Hospital.
Recruitment status was:  Recruiting
First Posted : December 31, 2014
Last Update Posted : July 12, 2017
Information provided by (Responsible Party):
Kristin Schreiber, Brigham and Women's Hospital

Brief Summary:
Chronic pain is devastating both to individuals and society. In an aging population, surgery is an increasing cause of chronic pain, with rates of persistent post-operative pain ranging from 10-65%.In particular, Persistent Post-Mastectomy Pain (PPMP) occurs in roughly one third of women who have had mastectomy. The occurrence of PPMP does not seem to be strongly determined by the type of surgery, chemotherapy, and radiation treatment, suggesting that individual person-specific factors may play a more important role. In fact, recent studies indicate that individual differences in pain sensitivity (psychophysics) are more closely associated with PPMP than surgical/medical variables. Specifically, sensory testing revealed that women who developed PPMP had lower pressure pain thresholds and greater temporal summation of pain stimuli than women who did not develop this chronic pain condition. Moreover, psychosocial factors such as anxiety, depression, catastrophizing, and somatization were more prominent in women with PPMP. These preliminary, retrospective studies suggest that individual psychophysical and psychosocial characteristics could be important risk factors for PPMP. Accordingly, the aim of this study is to comprehensively and prospectively study women having mastectomy surgery, to determine the relationship between pre-operative psychophysical and psychosocial factors and the development of PPMP. Using these data, a prediction model for PPMP will be developed, thus allowing a preoperative calculation of a "PPMP risk score" for any patient facing mastectomy.

Condition or disease
Chronic Pain

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Study Type : Observational
Estimated Enrollment : 200 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Prediction of Persistent Post-Mastectomy Pain
Study Start Date : October 2014
Estimated Primary Completion Date : October 2017
Estimated Study Completion Date : October 2017

Resource links provided by the National Library of Medicine

Primary Outcome Measures :
  1. Persistent mastectomy pain [ Time Frame: 1 year ]
    based the breast cancer pain questionnaire, which assesses multiple related body areas, severity and frequency of pain

Biospecimen Retention:   Samples With DNA

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Women undergoing partial or total mastectomy

Inclusion criteria:

  1. Female
  2. Aged 18-80 years
  3. Scheduled for total or partial mastectomy
  4. Willingness to undergo psychophysical and psychosocial testing
  5. Willingness to participate in long-term follow-up

Exclusion criteria:

  1. Scheduled for biopsy only
  2. Pregnant

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT02329574

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United States, Massachusetts
Brigham and Women's Hospital Recruiting
Boston, Massachusetts, United States, 02115
Contact: Kristin Schreiber, MD/PHD    612-205-0186   
Sponsors and Collaborators
Brigham and Women's Hospital
Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: Kristin Schreiber, Faculty, Department of Anesthesiology, Brigham and Women's Hospital Identifier: NCT02329574    
Other Study ID Numbers: 2013P002202
First Posted: December 31, 2014    Key Record Dates
Last Update Posted: July 12, 2017
Last Verified: July 2017
Additional relevant MeSH terms:
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Chronic Pain
Neurologic Manifestations