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
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
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
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
We'll reach out to this number within 24 hrs