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

Study Overview
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Brief Summary
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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
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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.

Official Title
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Study of Psychological and Sociological Predisposing the Development of Chronic Pain After Surgery in Women With Resectable Breast Cancer

Conditions
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Breast Cancer, Pain, Psychosocial Effects of Cancer and Its Treatment

Intervention / Treatment
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* Other: questionnaire administration
* Procedure: management of therapy complications
* Procedure: psychosocial assessment and care
* Procedure: quality-of-life assessment


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Intervention/Treatment |
| --- |
|Other: questionnaire administration|nan|
|Procedure: management of therapy complications|nan|
|Procedure: psychosocial assessment and care|nan|
|Procedure: quality-of-life assessment|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Development of post-mastectomy pain syndrome |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rate of post-surgical pain |  |  | 
| Rate of emotional distress |  |  | 
| Rate of acute and chronic pain |  |  | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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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