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

June 5, 2013 updated by: Kenneth Geving Andersen, Rigshospitalet, Denmark
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.

Study Overview

Status

Completed

Conditions

Study Type

Observational

Enrollment (Actual)

2411

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Denmark
      • Copenhagen, Denmark
        • Rigshospitalet, Copenhagen University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Sampling Method

Non-Probability Sample

Study Population

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

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
6-7 years post operative
Prevalence of patients changing pain status from the 2008 survey
Time Frame: 6-7 years
6-7 years

Secondary Outcome Measures

Outcome Measure
Time Frame
Prevalence of sensory disturbance
Time Frame: 6-7 years
6-7 years
Prevalence of self reported lymphedma
Time Frame: 6-7 years
6-7 years
Prevalence of functional impairment
Time Frame: 6-7 years
6-7 years
Risk factors associated for persistent pain, sensory disturbances, lymphedema or functional impairment
Time Frame: 6-7 years
6-7 years
Prevalence of patients changing status of sensory disturbances and self reported lymphedma
Time Frame: 6-7 years
6-7 years
Risk factors associated to changing status of sensory disturbances and lymphedema
Time Frame: 6-7 years post operative
6-7 years post operative

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Rigshospitalet, Denmark

Collaborators

Danish Cancer Society

Investigators

  • Principal Investigator: Kenneth Geving Andersen, MD, Rigshospitalet, Denmark

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2012

Primary Completion (Actual)

April 1, 2012

Study Completion (Actual)

April 1, 2012

Study Registration Dates

First Submitted

February 28, 2012

First Submitted That Met QC Criteria

March 2, 2012

First Posted (Estimate)

March 5, 2012

Study Record Updates

Last Update Posted (Estimate)

June 6, 2013

Last Update Submitted That Met QC Criteria

June 5, 2013

Last Verified

June 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2007-41-1530

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Pain

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Mali

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe