Trial Information

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

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.