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
  Purpose

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

Study Type: Observational
Official Title: Prospective Cohort Study to Investigate Chronic Pain After Breast Cancer Surgery

Resource links provided by NLM:


Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:
  • 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 ]

Estimated Enrollment: 284
Study Start Date: March 2007
Estimated Primary Completion Date: May 2010 (Final data collection date for primary outcome measure)
Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00971919

Locations
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
Investigators
Principal Investigator: Julie Bruce, MD, PhD Aberdeen Royal Infirmary
  More Information

Additional Information:
No publications provided

ClinicalTrials.gov Identifier: NCT00971919     History of Changes
Other Study ID Numbers: EU-20926, CDR0000639659, EU-20926
Study First Received: September 3, 2009
Last Updated: August 6, 2013
Health Authority: Unspecified

Keywords provided by National Cancer Institute (NCI):
pain
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
Postoperative Complications
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Pathologic Processes

ClinicalTrials.gov processed this record on July 20, 2014