|
Health Condition(s) or Problem
|
Breast Cancer; Pain; Perioperative/Postoperative Complications
|
|
Lay Summary
|
RATIONALE: Learning about chronic pain in women who have undergone surgery for breast cancer
may help improve the quality of life for these patients and may help doctors plan the best
treatment.
PURPOSE: This clinical trial is studying chronic pain in women who have undergone surgery
for stage I, stage II, or stage III breast cancer.
(from ClinicalTrials.gov)
|
|
Who can enter the trial
|
DISEASE CHARACTERISTICS:
- Histologically confirmed invasive breast cancer or carcinoma in situ of the breast by
core biopsy or fine needle aspiration
- Newly diagnosed disease
- Stage I-III disease
- Resectable disease
- Being treated in the Aberdeen, Dundee, Perth, or Inverness Breast Unit
- Planning to undergo primary surgical excision of the tumor (e.g., breast
conservation surgery or mastectomy with or without axillary surgery [sentinel
node biopsy, axillary sample, or axillary clearance])
- Planning to undergo standard adjuvant therapy after surgery, including
radiotherapy, chemotherapy, and/or hormonal therapy, as per existing standard
protocols
- No detectable metastatic disease
PATIENT CHARACTERISTICS:
- Not pregnant
- Speaks English
- No history of mental illness
PRIOR CONCURRENT THERAPY:
- See Disease Characteristics
|
|
Who cannot enter the trial
|
DISEASE CHARACTERISTICS:
- Histologically confirmed invasive breast cancer or carcinoma in situ of the breast by
core biopsy or fine needle aspiration
- Newly diagnosed disease
- Stage I-III disease
- Resectable disease
- Being treated in the Aberdeen, Dundee, Perth, or Inverness Breast Unit
- Planning to undergo primary surgical excision of the tumor (e.g., breast
conservation surgery or mastectomy with or without axillary surgery [sentinel
node biopsy, axillary sample, or axillary clearance])
- Planning to undergo standard adjuvant therapy after surgery, including
radiotherapy, chemotherapy, and/or hormonal therapy, as per existing standard
protocols
- No detectable metastatic disease
PATIENT CHARACTERISTICS:
- Not pregnant
- Speaks English
- No history of mental illness
PRIOR CONCURRENT THERAPY:
- See Disease Characteristics
|
|
What will happen
|
Other; questionnaire administration; Procedure; assessment of therapy complications; Procedure; psychosocial assessment and care; Procedure; quality-of-life assessment
|
|
Primary aim
|
Chronic pain at or near the surgical site persisting beyond the expected healing time as measured at 4 and 9 months after surgery; Identification of which psychological and quality of life variables, after controlling for baseline demographic, surgical, and other factors, are predictive of chronic pain at 4 and 9 months after surgery; Association between chronic pain status at 4 and 9 months after surgery and differential changes in quality-of-life outcomes since baseline
|
|
Secondary Aim
|
Sorry, not currently available
|
|
Participant Information Sheet
|
Sorry, not currently available
|
|
Website
|
http://cancer.gov/clinicaltrials/EU-20926
|
|
Recruitment Status
|
Recruiting
|
|
Nation
|
Scotland
|
|
Location
|
Aberdeen
|