Chronic Pain in Women Who Have Undergone Surgery for Stage I, Stage II, or Stage III Breast Cancer | Recruiting
Chronic Pain in Women Who Have Undergone Surgery for Stage I, Stage II, or Stage III Breast Cancer
Health Conditions
  • Breast Cancer
  • Pain
  • Perioperative/Postoperative Complications
Recruiting
Recruitment Status
NCT00971919
Primary Trial ID Number
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.
Primary Outcome Measures
  • Chronic pain at or near the surgical site persisting beyond the expected healing time as measured at 4 and 9 months after surgery; null; 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; null; Association between chronic pain status at 4 and 9 months after surgery and differential changes in quality-of-life outcomes since baseline; null
Secondary Outcome Measures
    Sorry, this information is not available
Research Question
  • 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.
Design Type
Sorry, this information is not available
Ethics Approval
Sorry, this information is not available
Publications
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Countries of Recruitment
United Kingdom
Participant Sex
Female
Participant Age Range
18 Years to N/A
Participant Type
Sorry, this information is not available
Trial Sample Size
284
Participant Inclusion Criteria
  • 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
Participant Exclusion Criteria
  • 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
Interventions
Other; questionnaire administration; null; []; Procedure; assessment of therapy complications; null; []; Procedure; psychosocial assessment and care; null; []; Procedure; quality-of-life assessment; null; []
Design Details
Sorry, this information is not available
Study Design
N/A
Results Reporting
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Acronym
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Scientific Title
Prospective Cohort Study to Investigate Chronic Pain After Breast Cancer Surgery
Secondary Trial Identifying Number
CDR0000639659; EU-20926
Website
http://cancer.gov/clinicaltrials/EU-20926
Study Funded By
Aberdeen Royal Infirmary
Funder Type
Sorry, this information is not available
Study Sponsored By
Aberdeen Royal Infirmary
Study Also Sponsored By
Sorry, this information is not available
Primary Sponsor Type
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Secondary Sponsor Type
Sorry, this information is not available
Key Dates

Date of First Enrollment
Date Not Available
Recruitment End Date
Date Not Available
Trial End Date
Date Not Available
Date added to Registry

03 Sep 2009

Last Updated

06 Aug 2013

Date Record Refreshed on UKCTG

31 Jul 2015