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Prospective Cohort Study to Investigate Chronic Pain After Breast Cancer Surgery


N/A
18 Years
N/A
Open (Enrolling)
Female
Breast Cancer, Pain, Perioperative/Postoperative Complications

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Trial Information

Prospective Cohort Study to Investigate Chronic Pain After Breast Cancer Surgery


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.

Inclusion 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

Type of Study:

Observational

Study Design:

N/A

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

Safety Issue:

No

Principal Investigator

Julie Bruce, MD, PhD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Aberdeen Royal Infirmary

Authority:

Unspecified

Study ID:

CDR0000639659

NCT ID:

NCT00971919

Start Date:

March 2007

Completion Date:

Related Keywords:

  • Breast Cancer
  • Pain
  • Perioperative/Postoperative Complications
  • 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
  • Breast Neoplasms
  • Postoperative Complications

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