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

This study has been completed.
Sponsor:
Collaborator:
Danish Cancer Society
Information provided by (Responsible Party):
Kenneth Geving Andersen, Rigshospitalet, Denmark
ClinicalTrials.gov Identifier:
NCT01543711
First received: February 28, 2012
Last updated: June 5, 2013
Last verified: June 2013

February 28, 2012
June 5, 2013
January 2012
April 2012   (final data collection date for primary outcome measure)
  • Prevalence of persistent pain [ Time Frame: 6-7 years post operative ] [ Designated as safety issue: No ]
    Prevalence of pain in the breast area, axilla, side of chest or arm, as a yes/no variable
  • Prevalence of patients changing pain status from the 2008 survey [ Time Frame: 6-7 years ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01543711 on ClinicalTrials.gov Archive Site
  • Prevalence of sensory disturbance [ Time Frame: 6-7 years ] [ Designated as safety issue: No ]
  • Prevalence of self reported lymphedma [ Time Frame: 6-7 years ] [ Designated as safety issue: No ]
  • Prevalence of functional impairment [ Time Frame: 6-7 years ] [ Designated as safety issue: No ]
  • Risk factors associated for persistent pain, sensory disturbances, lymphedema or functional impairment [ Time Frame: 6-7 years ] [ Designated as safety issue: No ]
  • Prevalence of patients changing status of sensory disturbances and self reported lymphedma [ Time Frame: 6-7 years ] [ Designated as safety issue: No ]
  • Risk factors associated to changing status of sensory disturbances and lymphedema [ Time Frame: 6-7 years post operative ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Long Term Follow-up of Persistent Pain, Sensory Disturbances and Lymphedema After Breast Cancer Treatment
Long Term Follow-up of Persistent Pain, Sensory Disturbances and Lymphedema After Breast Cancer Treatment

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.

Not Provided
Observational
Observational Model: Cohort
Time Perspective: Cross-Sectional
Not Provided
Not Provided
Non-Probability Sample

Woman treated for breast cancer in Denmark 2005-2006, and participated in the study in 2008

  • Breast Cancer
  • Pain
  • Post Operative Pain
  • Lymphedema
  • Neuropathy
Not Provided
Breast cancer survivors
Women treated for breast cancer, without signs of recurrence or metastasis

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
2411
April 2012
April 2012   (final data collection date for primary outcome measure)

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
Female
18 Years to 80 Years
No
Contact information is only displayed when the study is recruiting subjects
Denmark
 
NCT01543711
2007-41-1530
No
Kenneth Geving Andersen, Rigshospitalet, Denmark
Rigshospitalet, Denmark
Danish Cancer Society
Principal Investigator: Kenneth Geving Andersen, MD Rigshospitalet, Denmark
Rigshospitalet, Denmark
June 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP