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

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Medical Conditions
  • Breast Cancer
  • Pain
  • Perioperative/Postoperative Complications
Primary Contact Details
Unfortunately contact details are not available for this trial.
Recruitment Status
Recruiting
Trial source and source ID number
NCT00971919

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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.
Research Details
  • 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.
Phase
N/A
Study Design
N/A
Study Type
Observational
Intervention
Other : questionnaire administration, Procedure : assessment of therapy complications, Procedure : psychosocial assessment and care, Procedure : quality-of-life assessment

Study Arm Groups : , , ,

Intervention Type
See Interventions above
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
Publication(s)
Sorry, this information is not available
Result Reports
Check availability of results on the Clinicaltrials.gov website
This information is designed to help you decide whether this trial is of interest. In some cases it is provided as a link to more detailed patient information or it may still be awaited from the organisation running the trial. Please look again shortly if the information you need is not here or, if named, contact the researcher named above.
Gender
Female
Age Range
18 Years - N/A
Who Can Participate
Patients
Number of Participants
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
This is in the inclusion criteria above
This information is designed to help you decide whether this trial is of interest. In some cases it is provided as a link to more detailed patient information or it may still be awaited from the organisation running the trial. Please look again shortly if the information you need is not here or, if named, contact the researcher named above.
Trial Location(s)
Aberdeen
AB25 2ZD
Trial Contact(s)
Primary Trial Contact
Sorry, this information is not available
Other Trial Contacts
Sorry, this information is not available
Countries Recruiting
United Kingdom
This information is designed to help you decide whether this trial is of interest. In some cases it is provided as a link to more detailed patient information or it may still be awaited from the organisation running the trial. Please look again shortly if the information you need is not here or, if named, contact the researcher named above.
Scientific Title
Prospective Cohort Study to Investigate Chronic Pain After Breast Cancer Surgery
EudraCT Number
Not available for this trial
Funder(s)
    Sorry, this information is not available
Other Study ID Numbers
EU-20926
Sponsor(s)
Aberdeen Royal Infirmary
Key Dates

Recruitment Start Date

Mar 2007

Recruitment End Date

May 2010

Trial Start Date
Date Not Available
Trial End Date
Date Not Available
Date added to source

03 Sep 2009

Date updated in source

06 Aug 2013