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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified September 2009 by National Cancer Institute (NCI).
Recruitment status was  Recruiting
Sponsor:
Information provided by:
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00971919
First received: September 3, 2009
Last updated: August 6, 2013
Last verified: September 2009

September 3, 2009
August 6, 2013
March 2007
May 2010   (final data collection date for primary outcome measure)
  • Chronic pain at or near the surgical site persisting beyond the expected healing time as measured at 4 and 9 months after surgery [ Designated as safety issue: No ]
  • 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 [ Designated as safety issue: No ]
  • Association between chronic pain status at 4 and 9 months after surgery and differential changes in quality-of-life outcomes since baseline [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00971919 on ClinicalTrials.gov Archive Site
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Chronic Pain in Women Who Have Undergone Surgery for Stage I, Stage II, or Stage III Breast Cancer
Prospective Cohort Study to Investigate Chronic Pain After Breast Cancer Surgery

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.

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
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  • Breast Cancer
  • Pain
  • Perioperative/Postoperative Complications
  • Other: questionnaire administration
  • Procedure: assessment of therapy complications
  • Procedure: psychosocial assessment and care
  • Procedure: quality-of-life assessment
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
284
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May 2010   (final data collection date for primary outcome measure)

DISEASE CHARACTERISTICS:

  • 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
Female
18 Years and older
No
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United Kingdom
 
NCT00971919
EU-20926, CDR0000639659, EU-20926
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Aberdeen Royal Infirmary
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Principal Investigator: Julie Bruce, MD, PhD Aberdeen Royal Infirmary
National Cancer Institute (NCI)
September 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP