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

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00466830
• Other study ID #: CDR0000540539
• Secondary ID: IB-2005-31INCA-R
• Status: Completed
• Phase: N/A
• First received: April 25, 2007
• Last updated: May 12, 2011
• Start date: September 2005

Study information

• Verified date: May 2011
• Source: National Cancer Institute (NCI)
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Observational

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 .

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 150
• Est. primary completion date: May 2011
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Study Design

N/A

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms
• Chronic Pain
• Pain
• Psychosocial Effects of Cancer and Its Treatment

Intervention

Other:
• questionnaire administration

Procedure:
• management of therapy complications

• psychosocial assessment and care

• quality-of-life assessment

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Institut Bergonié

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Development of post-mastectomy pain syndrome
Secondary	Rate of post-surgical pain
Secondary	Rate of emotional distress
Secondary	Rate of acute and chronic pain