Heart and Blood Diseases

All Conditions

Heart Failure

Heart Diseases

MDASI-HF questionnaire provided to Doctor for symptom management.

MDASI-HF questionnaire collected not provided to Doctor.

M. D. Anderson Symptom Inventory - Heart Failure (MDASI-HF) questionnaire rating symptoms given in clinic Day 1, Weeks 4 \& 8.

MDASI-HF Questionnaire

Anecita Fadol, PhD, MS

Primary Objective:

To determine if there is a reduction in the mean symptom severity scores for the heart failure specific symptom items between baseline and at the end of three months between patients whose symptoms are managed using the MDASI-HF symptom assessment scores (treatment group) as a decision making guide, as compared to patients managed without using the MDASI-HF symptom assessment scores (control group).

Secondary Objectives:

1. Examine the correlation between mean symptom severity scores and the secondary endpoints of: a) exercise tolerance ( 6-minute walk), b) NYHA (New York Heart Association) functional classification, c) B-type natriuretic peptide (a biomarker for heart failure), and d) dose titration of HF (heart failure) medications.
2. Define symptom severity critical values in cancer patients with concurrent heart failure that trigger clinical intervention
3. Identify symptom clusters which may occur in cancer patients with concurrent heart failure.

Background for Study:

Heart failure means that the heart isn't pumping as well as it should be. Your body depends on the heart's pumping action to deliver oxygen- and nutrient-rich blood to the body's cells. When the cells are nourished properly, the body can function normally. With heart failure, the weakened heart can't supply the cells with enough blood. This results in fatigue and shortness of breath. Everyday activities such as walking, climbing stairs, or carrying groceries can become very difficult.

In the standard of care, patients tell their healthcare staff about their symptoms and are treated accordingly. The MDASI-HF program is a tool that is designed to try to improve this process by measuring how severe symptoms may be in patients with cancer and heart failure, as well as measuring how these symptoms may be affecting these patients' daily lives.

To take part in the MDASI-HF program, patients complete a questionnaire at clinic visits and at home. The home questionnaire is done over the phone. The symptom information that the patients report is provided to the healthcare staff, allowing the healthcare staff to closely monitor the symptoms and respond as needed.

You must have permission from your cardiologist in order to take part in this study.

Study Groups:

If you agree to take part in this study, you will be randomly assigned (as in the flip of a coin) to 1 of 2 groups. However, for your safety, the doctor may assign you to a certain group based on factors such as your age, sex, and the status of the heart disease.

All participants will complete the MDASI-HF questionnaire, which asks about symptoms. If you are in Group 1, your questionnaire responses will be provided to your doctor so the doctor can use that information to manage your symptoms. If you are in Group 2, your questionnaire responses, completed either in person or via phone, will not be provided to your doctor. All participants in this study will receive appropriate medical care for management of symptoms. Both groups will have all the same procedures.

Study Visits:

During this study, you will have a clinic visit to your doctor's office on Day 1 of the study and at Weeks 4, 8, and 12.

On Day 1, the following tests and procedures will be performed:

* You will watch a patient and family education video while you wait for the doctor. The video discusses heart failure, drugs, diet, exercise, and emotional issues related to living with heart failure. The video is less than 15 minutes long.
* You will be given a patient diary and a booklet that explains how to manage heart failure. You will complete this diary once a day, which should take about 5-10 minutes each time. In this diary, you will record your weight, blood pressure, and any drugs you are taking. You should bring the diary back to the clinic at each study visit to have it reviewed.
* You will complete the MDASI-HF questionnaire in the clinic. This questionnaire asks you to rate your symptoms on a scale of 0 to 10. A score of 0 would mean the symptom is not happening and a score of 10 means the symptom is at its worst. The symptoms include heart-related symptoms and other symptoms that may be related to cancer or treatments. The questionnaire also asks you how the symptoms may have interfered with your daily life. Completing the questionnaire should take about 15 minutes.
* The distance you are able to walk in 6 minutes will be measured. You will sign a separate consent form that will describe this 6-minute walk test in more detail.
* Blood (about 1 teaspoon) will be drawn for routine tests.
* Blood (about 1 teaspoon) will be drawn for biomarker testing. The biomarker being studied is a chemical "marker" in the blood that may be related to heart failure.
* If you have not had one in the last 90 days, you will have an echocardiogram performed to check your heart function as part of your standard of care.
* If you have not had one in the last month, you will have an electrocardiogram (ECG -- a test that measures the electrical activity of the heart).

At Weeks 4 and 8, you will complete the MDASI-HF questionnaire in the clinic. Blood (about 2 teaspoons) will be drawn for routine tests. Blood (about 1 teaspoon) will be drawn for biomarker testing.

Phone Questionnaire Completion Between Visits:

Between study visits (at Weeks 1, 2, 3, 5, 6, 7, 9, 10, and 11), you will receive a phone call once a week. The phone system is "automated," and it asks you the same MDASI-HF questions as the questionnaire that you completed at the clinic. For all of the questions, you will enter a number on your phone's keypad to answer the questions. Completing the phone questionnaire should take about 10-15 minutes each time. At the end of the phone questionnaire, the system will direct you in scheduling your next call.

For Group 1 participants only, if you report that any pain or shortness of breath symptoms at 5, or any other symptom is as severe as 7 or higher, the phone system will automatically contact the clinic nurse using an alert. The nurse will call you back within 24 hours. Based on the symptom(s), the nurse will advise you about what to do next (for example, change the dose of your drugs, come in to the clinic, or go to the emergency center). The nurse will also contact your doctor right away if necessary. In addition to reviewing these severe symptoms that you may report, the study staff will be reviewing all of your questionnaire responses on a routine basis.

For Group 2 participants only, your telephone answers will not contact a clinic nurse. If you experience severe pain, shortness of breath, or your symptoms worsen, please contact the clinic nurse right away at the numbers in your instruction booklet.

Management of Symptoms:

No matter if you are in Group 1 or Group 2, if at any time you notice that any of your symptoms seem to be getting worse, you should call the clinic nurse right away at the numbers in your instruction booklet. The clinic nurse will follow up to advise you about what to do next. For example, the nurse may change the dose of your drugs, tell you to come into the clinic, or tell you to go to the emergency center. The nurse will also contact your doctor right away, if necessary.

If you feel your symptoms are severe, visit the emergency room or call 911.

End-of-Study Visit:

At Week 12, the following tests and procedures will be performed:

* You will complete the MDASI-HF questionnaire using the computer in the clinic.
* Blood (about 1 tablespoon) will be drawn for routine tests.
* Blood (about 1 teaspoon) will be drawn for biomarker testing.
* You will perform a 6-minute walk test.
* An echocardiogram and ECG will be performed.

After the Week 12 visit, your participation in this study will be over.

This is an investigational study. At this time, the MDASI-HF program is only being used in research.

Up 144 patients will take part in this study. All will be enrolled at M. D. Anderson.

M. D. Anderson Symptom Inventory - Heart Failure (MDASI-HF) Symptom Management Program

MDASI-HF: Bridging the Symptom Management Gap in Patients With Cancer and Concurrent Heart Failure to Improve Outcomes

M.D. Anderson Cancer Center

Ventricular Dysfunction, Left

Ventricular Dysfunction

Participants undergo echocardiograms with contrast done at baseline and at months 2, 4, 6, 12, 18, and 30. Electrocardiogram performed at baseline. Symptom questionnaire completed at baseline and at months 1, 2, 4, 6, 12, 18, and 30. Telephone follow-up by study staff at months 3 and 5.

Participants undergo echocardiograms with contrast done at baseline and at months 2, 4, 6, 12, 18, and 30.

Echocardiograms

Electrocardiogram

Symptom questionnaire completed at baseline and at months 1, 2, 4, 6, 12, 18, and 30.

Symptom Questionnaire

Telephone follow-up by study staff at months 3 and 5.

Telephone Follow-Up

Anecita Fadol, PHD, MSN

The goal of this clinical trial is to learn if heart function remains normal after stopping heart failure medication in patients who have received chemotherapy.

If you agree to take part in this study, the following baseline tests and procedures will be performed on Day 1:

* Your complete medical history will be recorded.
* You will have a physical exam, including measurement of your vital signs (blood pressure, heart rate, and breathing rate).
* You will complete a questionnaire about any symptoms you may be having. The questionnaire should take about 5-10 minutes to complete.
* You will have an echocardiogram (ECHO) and an electrocardiogram (ECG) to check your heart function.
* You will have blood (about 3 tablespoons) drawn for routine tests. If you can become pregnant, part of this blood draw will be used for a pregnancy test. To take part in this study, you must not be pregnant.
* You will be given instructions on how to gradually wean yourself off of your heart failure medication.
* You will be given a machine that you will use to measure your blood pressure at home.

You will be asked to monitor your blood pressure and heart rate at home daily and keep the results in a diary. You should bring your diary to each study visit.

At Month 1:

* You will have a physical exam, including measurement of your vital signs.
* You will complete the questionnaire about any symptoms you may be having.
* You will have blood (about 2 teaspoons) drawn for routine tests.

At Months 2, 4, 6, 12, 18, and 30:

* You will have a physical exam, including measurement of your vital signs.
* You will complete the questionnaire about any symptoms you may be having.
* You will have an ECHO.
* You will have blood (about 2 teaspoons) drawn for routine tests.

At Months 3 and 5, you will have a telephone follow-up with a member of the research team.

Length of Study Participation:

You may continue taking part in the study for up to 6 continuous months with follow-up visits at Months 12, 18, and 30. You will no longer be able to take part if the disease gets worse, if intolerable side effects occur, or if you are unable to follow study directions.

This is an investigational study.

Up to 45 participants will be enrolled in this study. All will take part at MD Anderson.

REcovery of Left Ventricular Dysfunction in CAncer Patients (RECAP Trial)

A withdrawal failure is defined as a decrease in the LVEF when cardiac medications are discontinued as determined by echocardiogram to LVEF\<50% or a decrease by 10% from baseline measurement. Maintenance of LVEF is defined as LVEF≥50%. LVEF was assessed at Baseline, Months 2, 4, 6, 12, 18, \& 30.

To identify an increased troponin-I that can predict the possibility of HF medication withdrawal failure.

Weaning of Cardiac Medications Based on Therapeutic Category (i.e. Beta Blockers, ACE-I, ARB, or any combination of these medications.)

Intervention (Weaning)

Down titrated current dose by half each week until medication is off. Weaning order: ACE-I, ARB, and beta blocker.

Maintenance of LVEF ≥50% after weaning of heart failure medications.

Age, Categorical

Age, Continuous

< 30

>/= 30-39

>/= 40-49

>/= 50-59

>/= 60

Age, Customized

Sex: Female, Male

Ethnicity (NIH/OMB)

Race (NIH/OMB)

United States

Region of Enrollment

LVEF ≥50%, taking heart failure medications classified as Angiotension converting enzyme inhibitors (ACE-Inhibitors), Beta-blockers, and/or angiotension-receptor blockers (ARBs), no diabetes, no hypertension, no arrhythmias, cancer in remission for at least 6 months

Left ventricular ejection fraction (LVEF) ≥50%

Patients at MD Anderson that met inclusion criteria (specified in Recruitment Details) and not excluded due to: Cancer recurrence; documented history of hypertension, coronary artery disease, myocardial infarction, diabetes mellitus, amyloidosis or hemochromatosis; presence of HF symptoms (e.g. shortness of breath, edema); Pregnancy.

Dr. Anecita P. Fadol,PHD/Associate Professor, Department of Nursing

Maintained (LVEF </= 50%)

Withdrawal Failure (LVEF <50% or decrease of 10%)

Lost to Follow Up

Withdrawal by Subject

"Weaning of Cardiac Medications Based on Therapeutic Category (i.e. Beta Blockers, ACE-I, ARB, or any combination of these medications.)"

Determine the Percentage of Cancer Survivors That Maintain Left Ventricular Ejection Fraction (LVEF) ≥50% After Discontinuing Cardiac Medications: Beta Blockers, Angiotensin Converting Enzyme Inhibitors (ACE-I), or Angiotensin Receptor Blockers (ARB).

The standard deviation is 0 because every value collected over the course of the entire study was 0.03. Mean would be 0.03 with a standard deviation of 0

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
M. D. Anderson Symptom Inventory - Heart Failure (MDASI-HF) Symptom Management Program	NCT00827801	Heart Failure Cancer	MDASI-HF Questi...	18 Years -	M.D. Anderson Cancer Center
M. D. Anderson Symptom Inventory - Heart Failure (MDASI-HF) Symptom Management Program	NCT00827801	Heart Failure Cancer	MDASI-HF Questi...	18 Years -	M.D. Anderson Cancer Center
REcovery of Left Ventricular Dysfunction in CAncer Patients (RECAP Trial)	NCT02543294	Heart Failure Cancer Treatmen...	Echocardiograms Electrocardiogr... Symptom Questio... Telephone Follo...	18 Years -	M.D. Anderson Cancer Center
M. D. Anderson Symptom Inventory - Heart Failure (MDASI-HF) Symptom Management Program	NCT00827801	Heart Failure Cancer	MDASI-HF Questi...	18 Years -	M.D. Anderson Cancer Center
M. D. Anderson Symptom Inventory - Heart Failure (MDASI-HF) Symptom Management Program	NCT00827801	Heart Failure Cancer	MDASI-HF Questi...	18 Years -	M.D. Anderson Cancer Center

Spots Global Cancer Trial Database for hf

Every month we try and update this database with for hf cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Spots Global Cancer Trial Database for hf

Every month we try and update this database with for hf cancer trials from around the world to help patients and their families find trials that might be right for them. We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Every month we try and update this database with for hf cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.