Cardiac Monitoring of Post-Operative Cancer Patients Experiencing Atrial Fibrillation

NCT ID: NCT01253590

Last Updated: 2015-03-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Total Enrollment

5 participants

Study Classification

OBSERVATIONAL

Study Start Date

2010-12-31

Study Completion Date

2011-11-30

Brief Summary

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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.

Detailed Description

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Conditions

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Post-Operative Cancer Patients Experiencing Atrial Fibrillation

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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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.

questionnaire about the use of ECG device

Intervention Type BEHAVIORAL

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.

Interventions

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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.

Intervention Type BEHAVIORAL

Other Intervention Names

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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.

Eligibility Criteria

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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
Minimum Eligible Age

22 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Memorial Sloan Kettering Cancer Center

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Michelle Johnson, MD

Role: PRINCIPAL_INVESTIGATOR

Memorial Sloan Kettering Cancer Center

Locations

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Memorial Sloan Kettering Cancer Center

New York, New York, United States

Site Status

Countries

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United States

Related Links

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http://www.mskcc.org/mskcc/html/44.cfm

Memorial Sloan Kettering Cancer Center

Other Identifiers

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10-213

Identifier Type: -

Identifier Source: org_study_id

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