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Study of Psychological and Sociological Factors Predisposing the Development of Chronic Pain After Surgery in Women With Resectable Breast Cancer
Alternate Title Psychological and Social Factors That May Increase the Risk of Developing Chronic Pain After Surgery in Women With Breast Cancer
Objectives Primary
Secondary
Entry Criteria Disease Characteristics:
Prior/Concurrent Therapy:
Patient Characteristics:
Expected Enrollment 150A total of 150 patients will be accrued for this study. Outcomes Primary Outcome(s)Development of post-mastectomy pain syndrome Rate of post-surgical pain 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. Trial Lead Organizations Institut Bergonie
Note: The purpose of most clinical trials listed in this database is to test new cancer treatments, or new methods of diagnosing, screening, or preventing cancer. Because all potentially harmful side effects are not known before a trial is conducted, dose and schedule modifications may be required for participants if they develop side effects from the treatment or test. The therapy or test described in this clinical trial is intended for use by clinical oncologists in carefully structured settings, and may not prove to be more effective than standard treatment. A responsible investigator associated with this clinical trial should be consulted before using this protocol. ![]() |
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