Chronic Pain in Women Who Have Undergone Surgery for Stage I, Stage II, or Stage III Breast Cancer

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: NCT00971919
Recruitment Status : Unknown
Verified September 2009 by National Cancer Institute (NCI).
Recruitment status was:  Recruiting
First Posted : September 4, 2009
Last Update Posted : August 7, 2013
Information provided by:
National Cancer Institute (NCI)

Brief Summary:

RATIONALE: Learning about chronic pain in women who have undergone surgery for breast cancer may help improve the quality of life for these patients and may help doctors plan the best treatment.

PURPOSE: This clinical trial is studying chronic pain in women who have undergone surgery for stage I, stage II, or stage III breast cancer.

Condition or disease Intervention/treatment
Breast Cancer Pain Perioperative/Postoperative Complications Other: questionnaire administration Procedure: assessment of therapy complications Procedure: psychosocial assessment and care Procedure: quality-of-life assessment

Detailed Description:


  • 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.

Study Type : Observational
Estimated Enrollment : 284 participants
Official Title: Prospective Cohort Study to Investigate Chronic Pain After Breast Cancer Surgery
Study Start Date : March 2007
Estimated Primary Completion Date : May 2010

Resource links provided by the National Library of Medicine

Primary Outcome Measures :
  1. Chronic pain at or near the surgical site persisting beyond the expected healing time as measured at 4 and 9 months after surgery
  2. Identification of which psychological and quality of life variables, after controlling for baseline demographic, surgical, and other factors, are predictive of chronic pain at 4 and 9 months after surgery
  3. Association between chronic pain status at 4 and 9 months after surgery and differential changes in quality-of-life outcomes since baseline

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No


  • 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


  • Not pregnant
  • Speaks English
  • No history of mental illness


  • See Disease Characteristics

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): NCT00971919

United Kingdom
Aberdeen Royal Infirmary Recruiting
Aberdeen, Scotland, United Kingdom, AB25 2ZD
Contact: Julie Bruce, MD, PhD    44-1224-555-992      
Sponsors and Collaborators
Aberdeen Royal Infirmary
Principal Investigator: Julie Bruce, MD, PhD Aberdeen Royal Infirmary Identifier: NCT00971919     History of Changes
Other Study ID Numbers: EU-20926
CDR0000639659 ( Registry Identifier: PDQ (Physician Data Query) )
First Posted: September 4, 2009    Key Record Dates
Last Update Posted: August 7, 2013
Last Verified: September 2009

Keywords provided by National Cancer Institute (NCI):
perioperative/postoperative complications
breast cancer in situ
stage IA breast cancer
stage IB breast cancer
stage II breast cancer
stage IIIA breast cancer
stage IIIB breast cancer
stage IIIC breast cancer

Additional relevant MeSH terms:
Breast Neoplasms
Chronic Pain
Postoperative Complications
Neoplasms by Site
Breast Diseases
Skin Diseases
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Pathologic Processes