NCT01543711

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
2,411

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2012

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2012

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

February 28, 2012

Completed
6 days until next milestone

First Posted

Study publicly available on registry

March 5, 2012

Completed
27 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2012

Completed
Last Updated

June 6, 2013

Status Verified

June 1, 2013

Enrollment Period

3 months

First QC Date

February 28, 2012

Last Update Submit

June 5, 2013

Conditions

Breast CancerPainPost Operative PainLymphedemaNeuropathy

Keywords

Breast cancerpersistent painneuropathic painlymphedema

Outcome Measures

Primary Outcomes (2)

  • Prevalence of persistent pain

    Prevalence of pain in the breast area, axilla, side of chest or arm, as a yes/no variable

    6-7 years post operative

  • Prevalence of patients changing pain status from the 2008 survey

    6-7 years

Secondary Outcomes (6)

  • Prevalence of sensory disturbance

    6-7 years

  • Prevalence of self reported lymphedma

    6-7 years

  • Prevalence of functional impairment

    6-7 years

  • Risk factors associated for persistent pain, sensory disturbances, lymphedema or functional impairment

    6-7 years

  • Prevalence of patients changing status of sensory disturbances and self reported lymphedma

    6-7 years

  • +1 more secondary outcomes

Study Arms (1)

Breast cancer survivors

Women treated for breast cancer, without signs of recurrence or metastasis

Eligibility Criteria

Age18 Years - 80 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

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

You may not qualify if:

  • Recurrent or new primary cancer
  • Metastatic cancer
  • Reconstructive surgery

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Rigshospitalet, Copenhagen University Hospital

Copenhagen, Denmark

Location

Related Publications (3)

  • 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.

    PMID: 19903919BACKGROUND

  • 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.

    PMID: 21435953BACKGROUND

  • 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.

    PMID: 23580693DERIVED

MeSH Terms

Conditions

Breast NeoplasmsPainPain, PostoperativeLymphedemaNeuralgia

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue DiseasesNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsPostoperative ComplicationsPathologic ProcessesLymphatic DiseasesHemic and Lymphatic DiseasesPeripheral Nervous System DiseasesNeuromuscular DiseasesNervous System Diseases

Study Officials

  • Kenneth Geving Andersen, MD

    Rigshospitalet, Denmark

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD

Study Record Dates

First Submitted

February 28, 2012

First Posted

March 5, 2012

Study Start

January 1, 2012

Primary Completion

April 1, 2012

Study Completion

April 1, 2012

Last Updated

June 6, 2013

Record last verified: 2013-06

Locations

DK(1)