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

Aberdeen Royal Infirmary

Status: Unknown

Conditions: Breast Cancer; Perioperative/Postoperative Complications; Pain

Treatments: Procedure: quality-of-life assessment; Procedure: assessment of therapy complications; Other: questionnaire administration; Procedure: psychosocial assessment and care

Study type: Observational

Funder types: Other

Identifiers

NCT00971919

CDR0000639659 (Registry Identifier)

EU-20926

Details and patient eligibility

About

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.

Full 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.

Enrollment: 284 estimated patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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