Psychological and Social Factors That May Increase the Risk of Developing Chronic Pain After Surgery in Women With Breast Cancer

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00466830
Recruitment Status : Completed
First Posted : April 27, 2007
Last Update Posted : May 13, 2011
Information provided by:
National Cancer Institute (NCI)

Brief Summary:

RATIONALE: Certain psychological and social factors may increase the risk of developing chronic pain after surgery. Evaluating these factors over time in patients who have undergone surgery for breast cancer may help doctors plan treatment and improve patients' quality of life.

PURPOSE: This clinical trial is studying the psychological and social factors that may increase the risk of developing chronic pain after surgery in women with breast cancer .

Condition or disease Intervention/treatment
Breast Cancer Pain Psychosocial Effects of Cancer and Its Treatment Other: questionnaire administration Procedure: management of therapy complications Procedure: psychosocial assessment and care Procedure: quality-of-life assessment

Detailed Description:



  • Determine the psychological and sociological factors that predispose post-mastectomy pain syndrome after surgery in women with resectable breast cancer.


  • Determine the psychological and sociological factors that predispose post-surgical pain in these patients.
  • Evaluate emotional distress over time in these patients.
  • Evaluate the acute and chronic pain over time in these patients.

OUTLINE: This is a multicenter study.

Patients complete multiple questionnaires, including Hospital Anxiety and Depression Scale (HAD), Maudsley Personality Inventory (MPI), PCS, and QLQ-C30, to evaluate psychological variables (alexithymia, neurosis, repression of negative emotions, solicitude, dramatization, emotional distress) and quality of life.

Post-mastectomy chronic pain (PMCP) syndrome is measured immediately after surgery and at 24 hours, day 6, and 5 months post-surgery.

A subgroup of patients (20 with PMCP and 20 without PMCP) are followed at months 5 and 6 months post-surgery for medication use, pathological problems, morbid events, family history, and environmental factors.

PROJECTED ACCRUAL: A total of 150 patients will be accrued for this study.

Study Type : Observational
Estimated Enrollment : 150 participants
Official Title: Study of Psychological and Sociological Predisposing the Development of Chronic Pain After Surgery in Women With Resectable Breast Cancer
Study Start Date : September 2005
Actual Primary Completion Date : May 2011

Resource links provided by the National Library of Medicine

Primary Outcome Measures :
  1. Development of post-mastectomy pain syndrome

Secondary Outcome Measures :
  1. Rate of post-surgical pain
  2. Rate of emotional distress
  3. Rate of acute and chronic pain

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No


  • Diagnosis of breast cancer
  • Mastectomy or lumpectomy, including axillary lymph node dissection, planned
  • Analgesic fixed (or ordered) the morning of surgery

    • No stage III analgesic planned
  • Hormone receptor status not specified


  • Female
  • Menopausal status not specified
  • WHO performance status 0-2
  • Other prior malignancy allowed
  • No American Society of Anesthesiologists' class IV
  • No contraindication or drug addiction
  • No uncontrolled conditions, including any of the following:

    • Diabetes
    • Thyroid disease
    • Neuropsychiatric disease
    • Infection
    • Insufficient coronary function
    • NYHA class III-IV heart disease


  • No recent major surgery
  • No participation in another medical or surgical clinical trial in the past 30 days
  • Prior breast surgery for a benign lesion or malignant lesion allowed

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00466830

Sponsors and Collaborators
Institut Bergonié
Study Chair: Florence Dixmerias, MD Institut Bergonié Identifier: NCT00466830     History of Changes
Other Study ID Numbers: CDR0000540539
First Posted: April 27, 2007    Key Record Dates
Last Update Posted: May 13, 2011
Last Verified: May 2011

Keywords provided by National Cancer Institute (NCI):
psychosocial effects of cancer and its treatment
stage IIIA breast cancer
stage IIIB breast cancer
stage I breast cancer
stage II breast cancer
stage IIIC breast cancer

Additional relevant MeSH terms:
Breast Neoplasms
Chronic Pain
Neoplasms by Site
Breast Diseases
Skin Diseases
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms