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

Sponsor

Institut Bergonié (Other)

Overall Status

Completed

CT.gov ID

NCT00466830

Collaborator

(none)

150

Enrollment

Study Details

Study Description

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 .

Condition or Disease	Intervention/Treatment	Phase
Breast Cancer Pain Psychosocial Effects of Cancer and Its Treatment	Other: questionnaire administration Procedure: management of therapy complications Procedure: psychosocial assessment and care Procedure: quality-of-life assessment

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 Design

Study Type:

Observational

Anticipated Enrollment :

150 participants

Official Title:

Study of Psychological and Sociological Predisposing the Development of Chronic Pain After Surgery in Women With Resectable Breast Cancer

Study Start Date :

Sep 1, 2005

Actual Primary Completion Date :

May 1, 2011

Outcome Measures

Primary Outcome Measures

Development of post-mastectomy pain syndrome []

Secondary Outcome Measures

Rate of post-surgical pain []
Rate of emotional distress []
Rate of acute and chronic pain []

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

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