Clinical trial NCT00466830: Psychological and Social Factors That May Increase the Risk of Developing Chronic Pain After Surgery in Women With Breast Cancer
Official title: Study of Psychological and Sociological Predisposing the Development of Chronic Pain After Surgery in Women With Resectable Breast Cancer
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Breast Cancer
Pain
Psychosocial Effects of Cancer and Its Treatment
Keywords: pain
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
Lead sponsor: National Cancer Institute (NCI)
Sponsor class: NIH
First posted: 2007-04-27
Enrollment: 150
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no

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 .

Detailed description: OBJECTIVES:

Primary

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

Secondary

* 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.

Eligibility criteria: DISEASE CHARACTERISTICS:

* 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

PATIENT CHARACTERISTICS:

* 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

PRIOR CONCURRENT THERAPY:

* 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

Primary outcomes:
measure: Development of post-mastectomy pain syndrome
Secondary outcomes:
measure: Rate of post-surgical pain
measure: Rate of emotional distress
measure: Rate of acute and chronic pain
Other outcomes:
Locations:
Study officials:
affiliation: Institut Bergonié
name: Florence Dixmerias, MD
role: STUDY_CHAIR
References: