Psychological and Social Factors and Risk Chronic Pain After Surgery in Women With Breast Cancer

Withdrawn

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

• Registration Number: NCT00466830
• Lead Sponsor: Institut Bergonié

Brief Summary

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.

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.

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.

Study Timeline

• Study Start: 2005-09-01
• Study First Submitted: 2007-04-25
• Study First Submitted QC: 2007-04-25
• Study First Posted: 2007-04-27
• Primary Completion: 2011-05
• Study Completion: 2011-05-01
• Status Verified: 2025-09
• Last Update Submitted: 2025-09-10
• Last Update Posted: 2025-09-11

Recruitment & Eligibility

• Status: WITHDRAWN
• 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
Presence of post-mastectomy pain syndrome	At 3 months after surgery	Pain is measured using a visual analog scale (VAS), ranging from 0 (no pain) to 100 (worst pain ever).; A participant is considered to have pain syndrome if VAS score is \>= 70.