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Long Term Follow-up of Persistent Pain, Sensory Disturbances and Lymphedema After Breast Cancer Treatment

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ClinicalTrials.gov Identifier: NCT01543711
Recruitment Status : Completed
First Posted : March 5, 2012
Last Update Posted : June 6, 2013
Sponsor:
Collaborator:
Information provided by (Responsible Party):

Study Description
Brief Summary:
Persistent pain, sensory disturbances, lymphedema and functional impairment are frequently occurring late effects of breast cancer treatment. The investigators have previously published data on 3253 women treated for breast cancer in Denmark in the period 2005-2006. Very few studies have examined how these late effects change in time. The aim of this study is to examine in a well defined patient population any change in the prevalence of persistent pain, sensory disturbances, lymphedema and functional impairment, as well as risk factor profile.

Condition or disease
Breast Cancer Pain Post Operative Pain Lymphedema Neuropathy

Study Design

Study Type : Observational
Actual Enrollment : 2411 participants
Observational Model: Cohort
Time Perspective: Cross-Sectional
Official Title: Long Term Follow-up of Persistent Pain, Sensory Disturbances and Lymphedema After Breast Cancer Treatment
Study Start Date : January 2012
Primary Completion Date : April 2012
Study Completion Date : April 2012

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Groups and Cohorts

Group/Cohort
Breast cancer survivors
Women treated for breast cancer, without signs of recurrence or metastasis


Outcome Measures

Primary Outcome Measures :
  1. Prevalence of persistent pain [ Time Frame: 6-7 years post operative ]
    Prevalence of pain in the breast area, axilla, side of chest or arm, as a yes/no variable

  2. Prevalence of patients changing pain status from the 2008 survey [ Time Frame: 6-7 years ]

Secondary Outcome Measures :
  1. Prevalence of sensory disturbance [ Time Frame: 6-7 years ]
  2. Prevalence of self reported lymphedma [ Time Frame: 6-7 years ]
  3. Prevalence of functional impairment [ Time Frame: 6-7 years ]
  4. Risk factors associated for persistent pain, sensory disturbances, lymphedema or functional impairment [ Time Frame: 6-7 years ]
  5. Prevalence of patients changing status of sensory disturbances and self reported lymphedma [ Time Frame: 6-7 years ]
  6. Risk factors associated to changing status of sensory disturbances and lymphedema [ Time Frame: 6-7 years post operative ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Woman treated for breast cancer in Denmark 2005-2006, and participated in the study in 2008
Criteria

Inclusion Criteria:

  • Diagnosed with primary breast cancer between 2005-2006
  • Participated in a study in 2008

Exclusion Criteria:

  • Recurrent or new primary cancer
  • Metastatic cancer
  • Reconstructive surgery
Contacts and Locations

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To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01543711


Locations
Denmark
Rigshospitalet, Copenhagen University Hospital
Copenhagen, Denmark
Sponsors and Collaborators
Rigshospitalet, Denmark
Danish Cancer Society
Investigators
Principal Investigator: Kenneth Geving Andersen, MD Rigshospitalet, Denmark
More Information

Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Kenneth Geving Andersen, MD, Rigshospitalet, Denmark
ClinicalTrials.gov Identifier: NCT01543711     History of Changes
Other Study ID Numbers: 2007-41-1530
First Posted: March 5, 2012    Key Record Dates
Last Update Posted: June 6, 2013
Last Verified: June 2013

Keywords provided by Kenneth Geving Andersen, Rigshospitalet, Denmark:
Breast cancer
persistent pain
neuropathic pain
lymphedema

Additional relevant MeSH terms:
Breast Neoplasms
Lymphedema
Pain, Postoperative
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Lymphatic Diseases
Pain
Neurologic Manifestations
Nervous System Diseases
Postoperative Complications
Pathologic Processes
Signs and Symptoms