Chronic Pain in Women Who Have Undergone Surgery for Stage I, Stage II, or Stage III Breast Cancer
NCT ID: NCT00971919
Last Updated: 2013-08-07
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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UNKNOWN
284 participants
OBSERVATIONAL
2007-03-31
Brief Summary
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PURPOSE: This clinical trial is studying chronic pain in women who have undergone surgery for stage I, stage II, or stage III breast cancer.
Detailed Description
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* 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.
Conditions
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Keywords
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Interventions
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questionnaire administration
assessment of therapy complications
psychosocial assessment and care
quality-of-life assessment
Eligibility Criteria
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Inclusion Criteria
* Histologically confirmed invasive breast cancer or carcinoma in situ of the breast by core biopsy or fine needle aspiration
* Newly diagnosed disease
* Stage I-III disease
* Resectable disease
* Being treated in the Aberdeen, Dundee, Perth, or Inverness Breast Unit
* Planning to undergo primary surgical excision of the tumor (e.g., breast conservation surgery or mastectomy with or without axillary surgery \[sentinel node biopsy, axillary sample, or axillary clearance\])
* Planning to undergo standard adjuvant therapy after surgery, including radiotherapy, chemotherapy, and/or hormonal therapy, as per existing standard protocols
* No detectable metastatic disease
PATIENT CHARACTERISTICS:
* Not pregnant
* Speaks English
* No history of mental illness
PRIOR CONCURRENT THERAPY:
* See Disease Characteristics
18 Years
FEMALE
No
Sponsors
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Aberdeen Royal Infirmary
OTHER
Principal Investigators
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Julie Bruce, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
Aberdeen Royal Infirmary
Locations
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Aberdeen Royal Infirmary
Aberdeen, Scotland, United Kingdom
Countries
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Facility Contacts
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Julie Bruce, MD, PhD
Role: primary
Other Identifiers
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CDR0000639659
Identifier Type: REGISTRY
Identifier Source: secondary_id
EU-20926
Identifier Type: -
Identifier Source: secondary_id
EU-20926
Identifier Type: -
Identifier Source: org_study_id