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

Primary Purpose

Breast Cancer, Pain, Psychosocial Effects of Cancer and Its Treatment

Status
Completed
Phase
Locations
Study Type
Observational
Intervention
questionnaire administration
management of therapy complications
psychosocial assessment and care
quality-of-life assessment
Sponsored by
Institut Bergonié
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an observational trial for Breast Cancer focused on measuring 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

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept 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

Sites / Locations

    Outcomes

    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

    Full Information

    First Posted
    April 25, 2007
    Last Updated
    May 12, 2011
    Sponsor
    Institut Bergonié
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    1. Study Identification

    Unique Protocol Identification Number
    NCT00466830
    Brief Title
    Psychological and Social Factors That May Increase the Risk of Developing Chronic Pain After Surgery in Women With Breast Cancer
    Official Title
    Study of Psychological and Sociological Predisposing the Development of Chronic Pain After Surgery in Women With Resectable Breast Cancer
    Study Type
    Observational

    2. Study Status

    Record Verification Date
    May 2011
    Overall Recruitment Status
    Completed
    Study Start Date
    September 2005 (undefined)
    Primary Completion Date
    May 2011 (Actual)
    Study Completion Date
    undefined (undefined)

    3. Sponsor/Collaborators

    Name of the Sponsor
    Institut Bergonié

    4. Oversight

    5. 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 .
    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Breast Cancer, Pain, Psychosocial Effects of Cancer and Its Treatment
    Keywords
    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

    7. Study Design

    Enrollment
    150 (Anticipated)

    8. Arms, Groups, and Interventions

    Intervention Type
    Other
    Intervention Name(s)
    questionnaire administration
    Intervention Type
    Procedure
    Intervention Name(s)
    management of therapy complications
    Intervention Type
    Procedure
    Intervention Name(s)
    psychosocial assessment and care
    Intervention Type
    Procedure
    Intervention Name(s)
    quality-of-life assessment
    Primary Outcome Measure Information:
    Title
    Development of post-mastectomy pain syndrome
    Secondary Outcome Measure Information:
    Title
    Rate of post-surgical pain
    Title
    Rate of emotional distress
    Title
    Rate of acute and chronic pain

    10. Eligibility

    Sex
    Female
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility 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
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Florence Dixmerias, MD
    Organizational Affiliation
    Institut Bergonié
    Official's Role
    Study Chair

    12. IPD Sharing Statement

    Learn more about this trial

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

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