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

NCT00466830 | Withdrawn

• 1 other identifier: IB-2005-31
• Study Type: observational
• Target: N/A
• Locations: 0 countries
• Sites: N/A

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 .

Conditions

Breast Cancer; Pain; Psychosocial Effects of Cancer and Its Treatment

Keywords

pain; psychosocial effects of cancer and its treatment; stage IIIA breast cancer; stage IIIB breast cancer; stage I breast cancer; stage II breast cancer; stage IIIC breast cancer

Outcome Measures

Primary Outcomes (1)

• Presence of post-mastectomy pain syndrome

  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.

  At 3 months after surgery

Interventions

questionnaire administration OTHER

management of therapy complications PROCEDURE

psychosocial assessment and care PROCEDURE

quality-of-life assessment PROCEDURE

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

DISEASE CHARACTERISTICS: * Diagnosis of breast cancer * Mastectomy or lumpectomy, including axillary lymph node dissection, planned * Analgesic fixed (or ordered) the morning of surgery * No stage III analgesic planned * Hormone receptor status not specified PATIENT CHARACTERISTICS: * Female * Menopausal status not specified * WHO performance status 0-2 * Other prior malignancy allowed * No American Society of Anesthesiologists' class IV * No contraindication or drug addiction * No uncontrolled conditions, including any of the following: * Diabetes * Thyroid disease * Neuropsychiatric disease * Infection * Insufficient coronary function * NYHA class III-IV heart disease PRIOR CONCURRENT THERAPY: * No recent major surgery * No participation in another medical or surgical clinical trial in the past 30 days * Prior breast surgery for a benign lesion or malignant lesion allowed

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• Institut Bergonié: lead

MeSH Terms

Conditions

Breast Neoplasms; Pain

Interventions

Psychiatric Rehabilitation

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Rehabilitation; Therapeutics; Health Services; Health Care Facilities Workforce and Services

Study Officials

• Florence Dixmerias, MD

  Institut Bergonié

  STUDY CHAIR

Study Design

• Study Type: observational
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 25, 2007
• First Posted: April 27, 2007
• Study Start: September 1, 2005
• Primary Completion: May 1, 2011
• Study Completion: May 1, 2011
• Last Updated: September 11, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share