In English | En español
Questions About Cancer? 1-800-4-CANCER

Clinical Trials (PDQ®)

  • First Published: 9/2/2009

Page Options

  • Print This Page
  • Email This Document
Clinical Trial Questions?
Get Help:
1-800-4-CANCER
LiveHelp online chat

Clinical Trials (PDQ®)

Study of Chronic Pain in Women Who Have Undergone Surgery for Stage I-III Breast Cancer. Note: The information about this trial has not been updated by the sponsor/principal investigator/lead organization. Cancer.gov cannot verify the accuracy of the information.

Alternate Title
Basic Trial Information
Objectives
Entry Criteria
Expected Enrollment
Outcomes
Outline
Trial Contact Information
Registry Information

Alternate Title

Chronic Pain in Women Who Have Undergone Surgery for Stage I, Stage II, or Stage III Breast Cancer. Note: The information about this trial has not been updated by the sponsor/principal investigator/lead organization. Cancer.gov cannot verify the accuracy of the information.

Basic Trial Information

PhaseTypeStatusAgeSponsorProtocol IDs
No phase specifiedNatural history/Epidemiology, Supportive careUnknown18 and overOtherEU-20926
EU-20926, NCT00971919

Objectives

  1. 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.
  2. Assess the incidence of chronic pain at 4 and 9 months after breast cancer surgery.
  3. 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.

Entry 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

Prior/Concurrent Therapy:

  • See Disease Characteristics

Patient Characteristics:

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

Expected Enrollment

284

Outcomes

Primary Outcome(s)

Chronic pain at or near the surgical site persisting beyond the expected healing time as measured at 4 and 9 months after surgery
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
Association between chronic pain status at 4 and 9 months after surgery and differential changes in quality-of-life outcomes since baseline

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.

Trial Contact Information

Trial Lead Organizations

Aberdeen Royal Infirmary

Julie Bruce, MD, PhD, Principal investigator
Ph: 44-1224-555-992

Registry Information
Official Title Prospective cohort study to investigate chronic pain after breast cancer surgery
Trial Start Date 2007-03-01
Trial Completion Date 2010-05-27 (estimated)
Registered in ClinicalTrials.gov NCT00971919
Date Submitted to PDQ 2009-04-15
Information Last Verified 2009-09-02

Note: The purpose of most clinical trials listed in this database is to test new cancer treatments, or new methods of diagnosing, screening, or preventing cancer. Because all potentially harmful side effects are not known before a trial is conducted, dose and schedule modifications may be required for participants if they develop side effects from the treatment or test. The therapy or test described in this clinical trial is intended for use by clinical oncologists in carefully structured settings, and may not prove to be more effective than standard treatment. A responsible investigator associated with this clinical trial should be consulted before using this protocol.

Back to TopBack to Top