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

Completed

• Conditions: Breast Cancer; Pain; Psychosocial Effects of Cancer and Its Treatment

• Registration Number: NCT00466830
• Lead Sponsor: Institut Bergonié

Brief 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 .

Detailed 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 Timeline

• Study Start: 2005-09
• Study First Submitted: 2007-04-25
• Study First Submitted QC: 2007-04-25
• Study First Posted: 2007-04-27
• Status Verified: 2011-05
• Primary Completion: 2011-05
• Last Update Submitted: 2011-05-12
• Last Update Posted: 2011-05-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 150

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Development of post-mastectomy pain syndrome

Secondary Outcome Measures

Name	Time	Method
Rate of post-surgical pain
Rate of emotional distress
Rate of acute and chronic pain