Prospective Cohort Study to Investigate Chronic Pain After Breast Cancer Surgery
OBJECTIVES:
- Identify which preoperative psychological risk factors, after controlling for
demographic and clinical factors, are associated with chronic pain at 4 and 9 months
after breast cancer surgery.
- Assess the incidence of chronic pain at 4 and 9 months after breast cancer surgery.
- Determine whether pain status at 4 and 9 months after breast cancer surgery is
associated with changes in psychological well-being and health-related quality of life
over time.
OUTLINE: This is a multicenter study.
Patients complete a preoperative pain questionnaire that includes the McGill Pain
Questionnaire, a full body map, and the self-report Leeds Assessment of Neuropathic Symptoms
and Signs scale. Only those patients with preoperative pain are asked to compete the full
pain section of the questionnaire to assess location, severity, and type of pain. Acute
postoperative pain during the first week after surgery is assessed using a visual analog
scale (0-10). Patients then undergo telephone assessment of intensity and timing of acute
pain 7 days after surgery. Subsequent postoperative pain assessments are conducted by mail
using questionnaires at 4 and 9 months after surgery. Patients reporting chronic pain in the
region of the surgical site are asked to complete the detailed pain section of the
questionnaire.
Demographic variables, including age, education level, marital status, and body mass index,
are recorded at baseline. Psychological (anxiety and exaggerated negative beliefs about
pain) and quality-of-life outcomes are recorded at baseline and at 4 and 9 months
postoperatively.
Observational
N/A
Chronic pain at or near the surgical site persisting beyond the expected healing time as measured at 4 and 9 months after surgery
No
Julie Bruce, MD, PhD
Principal Investigator
Aberdeen Royal Infirmary
Unspecified
CDR0000639659
NCT00971919
March 2007
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