Clinical trial NCT01543711: Long Term Follow-up of Persistent Pain, Sensory Disturbances and Lymphedema After Breast Cancer Treatment
Official title: Long Term Follow-up of Persistent Pain, Sensory Disturbances and Lymphedema After Breast Cancer Treatment
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Breast Cancer
Pain
Post Operative Pain
Lymphedema
Neuropathy
Keywords: Breast cancer
persistent pain
neuropathic pain
lymphedema
Lead sponsor: Rigshospitalet, Denmark
Sponsor class: OTHER
Collaborators: name: Danish Cancer Society
First posted: 2012-03-05
Enrollment: 2411
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Woman treated for breast cancer in Denmark 2005-2006, and participated in the study in 2008

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.


Eligibility 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

Primary outcomes:
measure: Prevalence of persistent pain
timeFrame: 6-7 years post operative
measure: Prevalence of patients changing pain status from the 2008 survey
timeFrame: 6-7 years
Secondary outcomes:
measure: Prevalence of sensory disturbance
timeFrame: 6-7 years
measure: Prevalence of self reported lymphedma
timeFrame: 6-7 years
measure: Prevalence of functional impairment
timeFrame: 6-7 years
measure: Risk factors associated for persistent pain, sensory disturbances, lymphedema or functional impairment
timeFrame: 6-7 years
measure: Prevalence of patients changing status of sensory disturbances and self reported lymphedma
timeFrame: 6-7 years
measure: Risk factors associated to changing status of sensory disturbances and lymphedema
timeFrame: 6-7 years post operative
Other outcomes:
Locations:
city: Copenhagen
country: Denmark
facility: Rigshospitalet, Copenhagen University Hospital
Study officials:
affiliation: Rigshospitalet, Denmark
name: Kenneth Geving Andersen, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Gartner R, Jensen MB, Nielsen J, Ewertz M, Kroman N, Kehlet H. Prevalence of and factors associated with persistent pain following breast cancer surgery. JAMA. 2009 Nov 11;302(18):1985-92. doi: 10.1001/jama.2009.1568.
citation: Andersen KG, Kehlet H. Persistent pain after breast cancer treatment: a critical review of risk factors and strategies for prevention. J Pain. 2011 Jul;12(7):725-46. doi: 10.1016/j.jpain.2010.12.005. Epub 2011 Mar 24.
citation: Mejdahl MK, Andersen KG, Gartner R, Kroman N, Kehlet H. Persistent pain and sensory disturbances after treatment for breast cancer: six year nationwide follow-up study. BMJ. 2013 Apr 11;346:f1865. doi: 10.1136/bmj.f1865.