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


N/A
18 Years
N/A
Not Enrolling
Female
Breast Cancer, Pain, Psychosocial Effects of Cancer and Its Treatment

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Trial Information

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


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.

Inclusion 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

Type of Study:

Observational

Study Design:

N/A

Outcome Measure:

Development of post-mastectomy pain syndrome

Principal Investigator

Florence Dixmerias, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Institut BergoniƩ

Authority:

United States: Federal Government

Study ID:

CDR0000540539

NCT ID:

NCT00466830

Start Date:

September 2005

Completion Date:

Related Keywords:

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

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