Communicating Health Information and Improving Coordination With Primary Care



Status:Enrolling by invitation
Conditions:Cancer, High Blood Pressure (Hypertension), High Cholesterol
Therapuetic Areas:Cardiology / Vascular Diseases, Oncology
Healthy:No
Age Range:18 - Any
Updated:4/6/2019
Start Date:March 1, 2017
End Date:March 1, 2022

Use our guide to learn which trials are right for you!

Communicating Health Information and Improving Coordination With Primary Care - an Ancillary Study of the Childhood Cancer Survivor Study

Survivors of childhood cancer are known to be at higher risk of developing premature, serious
cardiovascular disease compared with the general population. Hypertension, dyslipidemia, and
diabetes increase this risk beyond that attributable to one's original cancer therapy
exposures. Research has shown that childhood cancer survivors also have a high burden of
underdiagnosis and undertreatment of these potentially modifiable conditions. The goal of
this study is to:

1. To determine the prevalence of underdiagnosis and undertreatment of common
cardiometabolic conditions (i.e., hypertension, dyslipidemia, diabetes) in survivors of
childhood cancer at high-risk of future serious cardiovascular disease.

2. Among survivors who are found to be underdiagnosed or undertreated, to determine (via
randomized clinical trial) the efficacy of an educational intervention to improve
control of these cardiometabolic conditions.

3. Determine barriers on among survivors enrolled on the randomized trial and their primary
healthcare providers that contribute to undertreatment of the study's targeted
cardiometabolic conditions.

What is the CHIIP Study? The CHIIP Study is for Long-Term Follow-Up (LTFU) Study participants
who are more likely to experience heart problems because of their cancer treatment. We want
to figure out how common high blood pressure, high blood cholesterol, and high blood sugar
are among LTFU Study participants.

What will be asked of participants?

LTFU Study participants who choose to enroll in this study will be asked to:

- Answer one or two short questionnaires about their medical history, current health,
mood, lifestyle, and healthcare access.

- Schedule a one-time visit for an examiner to come to their home (or another location
chosen by the participant) to measure blood pressure, height, weight, waist
circumference, and to draw blood to test their cholesterol and blood sugar.

- If all the test results are normal, the participant will be done with the study. If the
participant has a higher than normal test result, they will remain in the study and be
randomly assigned to one of two groups to learn how to improve health. A year later,
participants in both groups will be asked to repeat the tests mentioned above.

What's in it for participants? Participants will have some basic health measurements done for
free, including height, weight, blood pressure, and blood levels of cholesterol and sugar.

The participant and their primary care provider will receive a copy of all these test results
free of cost. We hope the information we gather will provide future benefits for people who
were treated for cancer as children.

Inclusion Criteria:

- CCSS participant who is age ≥18 years at time of consent

- High cardiovascular risk status based on CCSS risk prediction models for
cardiomyopathy and ischemic heart disease

- Able to read, write, and speak English

- Living in the U.S., within 50 miles of a designated EMSI center based on CCSS's
available contact information at the time of approach.

- At least one abnormal CV condition identified on home visit: blood pressure ≥130/80
mmHg or ≥130/80 if pre-existing hypertension; LDL ≥160 mg/dL; triglyceride ≥150 mg/dL
(if ≥10 hours fast) or ≥200 mg/dL (if <10 hours fast); or glucose ≥100 mg/dL if ≥8
hours fast) or ≥140 mg/dL (if <8 hours fast) or HbA1c ≥5.7% (if not known to be
diabetic), HbA1c ≥7% (if known diabetic)

- Free of known self-reported ischemic heart disease or cardiomyopathy

- Have access to a telephone, computer, or smartphone to receive a phone or web
video-based educational intervention

Exclusion Criteria:

- Individuals with known cardiomyopathy or ischemic heart disease based on prior CCSS
surveys are excluded. While not likely to be common, participants who newly report in
our study's baseline survey that they have cardiomyopathy or ischemic heart disease
can have a home visit completed but will then be done with the study regardless of
their home visit results.

- Not currently known to be pregnant; individuals known to be pregnant and otherwise
eligible for the study can be enrolled once no longer known to be pregnant.
Participants who report being pregnant AFTER randomization can remain in the study.
We found this trial at
1
site
1100 Fairview Avenue North
Seattle, Washington 98109
(206) 667-5000
Fred Hutchinson Cancer Research Center At Fred Hutchinson Cancer Research Center, our interdisciplinary teams of...
?
mi
from
Seattle, WA
Click here to add this to my saved trials