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Chronic Pain in Women Who Have Undergone Surgery for Stage I, Stage II, or Stage III Breast Cancer

Primary Purpose

Breast Cancer, Pain, Perioperative/Postoperative Complications

Status
Unknown status
Phase
Locations
United Kingdom
Study Type
Observational
Intervention
questionnaire administration
assessment of therapy complications
psychosocial assessment and care
quality-of-life assessment
Sponsored by
Aberdeen Royal Infirmary
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an observational trial for Breast Cancer focused on measuring pain, perioperative/postoperative complications, breast cancer in situ, stage IA breast cancer, stage IB breast cancer, stage II breast cancer, stage IIIA breast cancer, stage IIIB breast cancer, stage IIIC breast cancer

Eligibility Criteria

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

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

Sites / Locations

  • Aberdeen Royal InfirmaryRecruiting

Outcomes

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
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 Outcome Measures

Full Information

First Posted
September 3, 2009
Last Updated
August 6, 2013
Sponsor
Aberdeen Royal Infirmary
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1. Study Identification

Unique Protocol Identification Number
NCT00971919
Brief Title
Chronic Pain in Women Who Have Undergone Surgery for Stage I, Stage II, or Stage III Breast Cancer
Official Title
Prospective Cohort Study to Investigate Chronic Pain After Breast Cancer Surgery
Study Type
Observational

2. Study Status

Record Verification Date
September 2009
Overall Recruitment Status
Unknown status
Study Start Date
March 2007 (undefined)
Primary Completion Date
May 2010 (Anticipated)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
Aberdeen Royal Infirmary

4. Oversight

5. Study Description

Brief 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.
Detailed Description
OBJECTIVES: Identify which preoperative psychological risk factors, after controlling for demographic and clinical factors, are associated with chronic pain at 4 and 9 months after breast cancer surgery. Assess the incidence of chronic pain at 4 and 9 months after breast cancer surgery. Determine whether pain status at 4 and 9 months after breast cancer surgery is associated with changes in psychological well-being and health-related quality of life over time. OUTLINE: This is a multicenter study. Patients complete a preoperative pain questionnaire that includes the McGill Pain Questionnaire, a full body map, and the self-report Leeds Assessment of Neuropathic Symptoms and Signs scale. Only those patients with preoperative pain are asked to compete the full pain section of the questionnaire to assess location, severity, and type of pain. Acute postoperative pain during the first week after surgery is assessed using a visual analog scale (0-10). Patients then undergo telephone assessment of intensity and timing of acute pain 7 days after surgery. Subsequent postoperative pain assessments are conducted by mail using questionnaires at 4 and 9 months after surgery. Patients reporting chronic pain in the region of the surgical site are asked to complete the detailed pain section of the questionnaire. Demographic variables, including age, education level, marital status, and body mass index, are recorded at baseline. Psychological (anxiety and exaggerated negative beliefs about pain) and quality-of-life outcomes are recorded at baseline and at 4 and 9 months postoperatively.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Breast Cancer, Pain, Perioperative/Postoperative Complications
Keywords
pain, perioperative/postoperative complications, breast cancer in situ, stage IA breast cancer, stage IB breast cancer, stage II breast cancer, stage IIIA breast cancer, stage IIIB breast cancer, stage IIIC breast cancer

7. Study Design

Enrollment
284 (Anticipated)

8. Arms, Groups, and Interventions

Intervention Type
Other
Intervention Name(s)
questionnaire administration
Intervention Type
Procedure
Intervention Name(s)
assessment 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
Chronic pain at or near the surgical site persisting beyond the expected healing time as measured at 4 and 9 months after surgery
Title
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
Title
Association between chronic pain status at 4 and 9 months after surgery and differential changes in quality-of-life outcomes since baseline

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Julie Bruce, MD, PhD
Organizational Affiliation
Aberdeen Royal Infirmary
Official's Role
Principal Investigator
Facility Information:
Facility Name
Aberdeen Royal Infirmary
City
Aberdeen
State/Province
Scotland
ZIP/Postal Code
AB25 2ZD
Country
United Kingdom
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Julie Bruce, MD, PhD
Phone
44-1224-555-992

12. IPD Sharing Statement

Learn more about this trial

Chronic Pain in Women Who Have Undergone Surgery for Stage I, Stage II, or Stage III Breast Cancer

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