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Clinical Trial 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 .


Clinical Trial 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. ;


Study Design

N/A


Related Conditions & MeSH terms


NCT number NCT00466830
Study type Observational
Source National Cancer Institute (NCI)
Contact
Status Completed
Phase N/A
Start date September 2005

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