Psychological and Social Factors That May Increase the Risk of Developing Chronic Pain After Surgery in Women With Breast Cancer
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|ClinicalTrials.gov Identifier: NCT00466830|
Recruitment Status : Completed
First Posted : April 27, 2007
Last Update Posted : May 13, 2011
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|
- 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|
- Development of post-mastectomy pain syndrome
- Rate of post-surgical pain
- Rate of emotional distress
- Rate of acute and chronic pain
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 ClinicalTrials.gov identifier (NCT number): NCT00466830
|Study Chair:||Florence Dixmerias, MD||Institut Bergonié|