Post-Operative Cancer Patients Experiencing AtrialNCT01253590
Cardiac Monitoring of Post-Operative Cancer Patients Experiencing Atrial Fibrillation
An observational study of Post-Operative Cancer Patients Experiencing Atrial and Fibrillation, run by Memorial Sloan Kettering Cancer Center at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 22 years and older
- Conditions the study is for
- Post-Operative Cancer Patients Experiencing Atrial, Fibrillation
- What is being tested?
- questionnaire about the use of ECG device
- Type of treatment
- Pill or oral medicine, Lifestyle or therapy programme
- How many people
- 5 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 2010to Nov 2011
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 22 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- Non-English speaking patients
Trial locations and contacts
1 site in 1 country.
United States1 site
Memorial Sloan Kettering Cancer Center
New York, New York, 10065
About this study
Official title: 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.
- Being tested
- questionnaire about the use of ECG device
- Keywords
- atrial fibrillation, ECG monitor, Blood pressure device, Remote Cardiac Monitoring
- Medical subject headings
- Atrial Fibrillation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
questionnaire about the use of ECG deviceBehavioural
Also called 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.
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: questionnaire about the use of ECG device |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 4 to 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Dec 2010 (estimated)
- Study startDec 2010
- Primary completionNov 2011
- Study completionNov 2011
Why it stopped: Lack of accrual
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Post-Operative Cancer Patients Experiencing AtrialStudies of the same condition, open and under way.
- More trials run by Memorial Sloan Kettering Cancer CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 5 participants (actual)
Sponsor and investigators
- Lead sponsor
- Memorial Sloan Kettering Cancer Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Michelle Johnson, MD, Principal investigator, Memorial Sloan Kettering Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01253590
- Sponsor's protocol ID
- 10-213
- Status last verified
- Mar 2015
- First submitted
- 2 Dec 2010
- Last updated
- 6 Mar 2015
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Mar 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Feasibility of Remote Cardiac Monitoring of Post-Operative Cancer Patients Experiencing Atrial Fibrillation
- ClinicalTrials.gov ID
- NCT01253590
- Acronym / sponsor ID
- 10-213
- Keywords
- atrial fibrillation, ECG monitor, Blood pressure device, Remote Cardiac Monitoring
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: Lack of accrual
- Enrolment
- 5 participants (actual)
- Lead sponsor
- Memorial Sloan Kettering Cancer CenterUniversity, hospital or other
- Study start
- Dec 2010
- Primary completion
- Nov 2011 (actual)
- Study completion
- Nov 2011 (actual)
- First posted
- 3 Dec 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| post op cancer patients experiencing atrial fibrillation | – | Behavioral: questionnaire about the use of ECG deviceThis 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. |
Who may qualify
- Ages
- 22 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (1 listed)
- Non-English speaking patients
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| questionnaire about the use of ECG deviceAlso: 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.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. | Behavioural | post op cancer patients experiencing atrial fibrillation |
Primary outcome
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.
Results and safety
The study was stopped early (reason given: Lack of accrual). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Mar 2015.
- Memorial Sloan Kettering Cancer CenterLink provided by the sponsor.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Michelle Johnson, MD principal investigator
Memorial Sloan Kettering Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Post-Operative Cancer Patients Experiencing Atrial and Fibrillation, run by Memorial Sloan Kettering Cancer Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 6 Mar 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Lack of accrual). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Assess the feasibility and acceptance of continuous remote cardiac monitoring (time frame: 4 to 6 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Mar 2015.