Breast Cancer Clinical Trial
Official title:
Study of Psychological and Sociological Predisposing the Development of Chronic Pain After Surgery in Women With Resectable Breast Cancer
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 .
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.
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