Cardiac Monitoring of Post-Operative Cancer Patients Experiencing Atrial Fibrillation

March 4, 2015 updated by: Memorial Sloan Kettering Cancer Center

Feasibility of Remote Cardiac Monitoring of Post-Operative Cancer Patients Experiencing Atrial Fibrillation

The purpose of this study is to assess whether it is possible and acceptable to monitor patients at a distance who experience a condition called atrial fibrillation after their cancer surgery. Some patients have no other clinical reason for staying in the hospital after cancer surgery except in order to control their heart rhythm. Being able to send these patients home earlier and monitor them at a distance from their home can be good for their quick recovery. Studies have shown greater quality of life and patient satisfaction when patients are monitored at a distance for conditions like atrial fibrillation, however cancer patients have not been studied.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

5

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

  • United States
    • New York
      • New York, New York, United States, 10065
        • Memorial Sloan Kettering Cancer Center

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

22 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Two cardiology attending physicians, Dr. Michelle Johnson and Dr. Carol L. Chen, who are members of this research team, will identify post-operative patients whose primary attending has made a decision to discharge.

Description

Inclusion Criteria:

  • Post-Operative cancer patients experiencing atrial fibrillation and otherwise clinically ready to be discharged.
  • Must attend two outpatient visits at MSKCC's cardiology practice during the study period, as specified by the participant's Attending.
  • Must be older than 21 years of age.

Exclusion Criteria:

  • Non-English speaking patients

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
Intervention / Treatment
post op cancer patients experiencing atrial fibrillation
This small study aims to assess the feasibility and acceptance of remote cardiac monitoring of postoperative cancer patients experiencing atrial fibrillation and will collect continuous data on heart beat over a period of 4-6 weeks upon discharge.
Behavioral: questionnaire about the use of ECG device
Patients will be fitted with a continuous ECG monitor and blood pressure device. Data on every heart beat, including episodes of atrial fibrillation, for 4-6 weeks of continuous monitoring will be collected and transmitted wirelessly. Based on this information and blood pressure readings performed by patients in their home setting, clinicians can adjust oral coagulant dosage. Participants will attend 2 follow-up outpatient visits at the MSKCC outpatient cardiology practice upon the cardiologist's recommendation. Upon completion of the study, 4-6 weeks, a questionnaire will be sent via mail, including a pre-paid envelope, to participants to assess feasibility, acceptance, and overall experience with remote cardiac monitoring.
Other Names:
  • Upon obtaining written informed consent, a technician from Ocean Empire
  • Diagnostic & Monitoring Group will equip the participant with the ECG device and
  • demonstrate the use. This is standard practice at MSKCC for 24 hour holters
  • and we will be using the same company to equip patients with the ECG device.
  • Participants will also be equipped with a blood pressure device for use at
  • home during the 4-6 week period and the RN will demonstrate its use.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Assess the feasibility and acceptance of continuous remote cardiac monitoring
Time Frame: 4 to 6 weeks
In post-operative patients with respect to recurrence of post-operative atrial fibrillation upon discharge.
4 to 6 weeks

Collaborators and Investigators

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

Sponsor

Memorial Sloan Kettering Cancer Center

Investigators

  • Principal Investigator: Michelle Johnson, MD, Memorial Sloan Kettering Cancer Center

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.

Helpful Links

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

December 1, 2010

Primary Completion (Actual)

November 1, 2011

Study Completion (Actual)

November 1, 2011

Study Registration Dates

First Submitted

December 2, 2010

First Submitted That Met QC Criteria

December 2, 2010

First Posted (Estimate)

December 3, 2010

Study Record Updates

Last Update Posted (Estimate)

March 6, 2015

Last Update Submitted That Met QC Criteria

March 4, 2015

Last Verified

March 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 10-213

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.

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