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

This study has been completed.
Sponsor:
Information provided by:
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00466830
First received: April 25, 2007
Last updated: May 12, 2011
Last verified: May 2011
  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
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

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

Resource links provided by NLM:


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
Primary Completion Date: May 2011 (Final data collection date for primary outcome measure)
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Sponsors and Collaborators
Institut Bergonié
Investigators
Study Chair: Florence Dixmerias, MD Institut Bergonié
  More Information

Additional Information:
No publications provided

ClinicalTrials.gov Identifier: NCT00466830     History of Changes
Other Study ID Numbers: CDR0000540539, IB-2005-31, INCA-RECF0143, IB-SDPM
Study First Received: April 25, 2007
Last Updated: May 12, 2011
Health Authority: United States: Federal Government

Keywords provided by National Cancer Institute (NCI):
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

Additional relevant MeSH terms:
Breast Neoplasms
Chronic Pain
Breast Diseases
Neoplasms
Neoplasms by Site
Nervous System Diseases
Neurologic Manifestations
Pain
Signs and Symptoms
Skin Diseases

ClinicalTrials.gov processed this record on November 19, 2014