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

Sponsored by:	Institut Bergonie
Information provided by:	National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:	NCT00466830

Purpose

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	Intervention
Breast Cancer Cancer-Related Problem/Condition Pain	Procedure: management of therapy complications Procedure: psychosocial assessment and care Procedure: quality-of-life assessment Procedure: questionnaire administration

Genetics Home Reference related topics: breast cancer

MedlinePlus related topics: Breast Cancer Cancer

U.S. FDA Resources

Study Type:	Observational
Official Title:	Study of Psychological and Sociological Predisposing the Development of Chronic Pain After Surgery in Women With Resectable Breast Cancer

Further study details as provided by National Cancer Institute (NCI):

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

Estimated Enrollment:	150
Study Start Date:	September 2005

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.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Female
Accepts Healthy Volunteers:	No

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00466830

Sponsors and Collaborators

Institut Bergonie

Investigators

Study Chair:

Florence Dixmerias, MD

Institut Bergonie

More Information

Clinical trial summary from the National Cancer Institute's PDQ® database This link exits the ClinicalTrials.gov site

Study ID Numbers:	CDR0000540539, IB-2005-31, INCA-RECF0143, IB-SDPM
Study First Received:	April 25, 2007
Last Updated:	October 18, 2008
ClinicalTrials.gov Identifier:	NCT00466830
Health Authority:	United States: Federal Government

Keywords provided by National Cancer Institute (NCI):

pain
psychosocial effects/treatment
stage IIIA breast cancer
stage IIIB breast cancer

stage I breast cancer
stage II breast cancer
stage IIIC breast cancer

Study placed in the following topic categories:

Skin Diseases
Breast Neoplasms
Pain
Breast Diseases

Additional relevant MeSH terms:

Neoplasms
Neoplasms by Site

ClinicalTrials.gov processed this record on January 15, 2009