Cardiac Monitoring of Post-Operative Cancer Patients Experiencing Atrial Fibrillation

NCT01253590 | Terminated

• 1 other identifier: 10-213
• Study Type: observational
• Target: 5
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Post-Operative Cancer Patients Experiencing Atrial; Fibrillation

Keywords

atrial fibrillation; ECG monitor; Blood pressure device; Remote Cardiac Monitoring

Outcome Measures

Primary Outcomes (1)

• Assess the feasibility and acceptance of continuous remote cardiac monitoring

  In post-operative patients with respect to recurrence of post-operative atrial fibrillation upon discharge.

  4 to 6 weeks

Study Arms (1)

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

Interventions

questionnaire about the use of ECG device 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.

Also known as: 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.

post op cancer patients experiencing atrial fibrillation

Eligibility Criteria

• Age: 22 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• Non-English speaking patients

Sponsors & Collaborators

• Memorial Sloan Kettering Cancer Center: lead

Study Sites (1)

Memorial Sloan Kettering Cancer Center

New York, New York, 10065, United States

Location

Related Links

• Memorial Sloan Kettering Cancer Center

MeSH Terms

Conditions

Atrial Fibrillation

Condition Hierarchy (Ancestors)

Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Michelle Johnson, MD

  Memorial Sloan Kettering Cancer Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 2, 2010
• First Posted: December 3, 2010
• Study Start: December 1, 2010
• Primary Completion: November 1, 2011
• Study Completion: November 1, 2011
• Last Updated: March 6, 2015

Record last verified: 2015-03

Locations

US (1)