Breast Cancer, Pain, Psychosocial Effects of Cancer and Its Treatment
Conditions
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
Brief summary
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. 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. 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.
Interventions
OTHERquestionnaire administration
PROCEDUREmanagement of therapy complications
PROCEDUREpsychosocial assessment and care
PROCEDUREquality-of-life assessment
Sponsors
Institut Bergonié
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Presence of post-mastectomy pain syndrome | At 3 months after surgery | Pain is measured using a visual analog scale (VAS), ranging from 0 (no pain) to 100 (worst pain ever). A participant is considered to have pain syndrome if VAS score is \>= 70. |
Outcome results
None listed