Clinical trial NCT03104543: Communicating Health Information and Improving Coordination With Primary Care
Official title: Communicating Health Information and Improving Coordination With Primary Care - an Ancillary Study of the Childhood Cancer Survivor Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hypertension
Dyslipidemias
Diabetes
Childhood Cancer
Keywords: survivor
undertreatment
adherence
self-efficacy
Lead sponsor: Fred Hutchinson Cancer Center
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
name: St. Jude Children's Research Hospital
First posted: 2017-04-07
Enrollment: 347
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized clinical trial of an educational intervention
Primary purpose: SUPPORTIVE_CARE

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: 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.
* Individuals receiving active cancer treatment. Participants who report starting active cancer treatment AFTER randomization can remain in the study.

Primary outcomes:
measure: Undertreatment of Hypertension (>=140/90 mmHg), Dyslipidemia (LDL >=160 mg/dL or Triglyceride >=150 mg/dL), and/or Glucose Intolerance (if Prediabetes, Hemoglobin A1c >=5.7% or Fasting Glucose >=100; if Diabetes, Hemoglobin A1c >=7%)
timeFrame: 1 year
Secondary outcomes:
measure: Health Knowledge
timeFrame: 1 year
measure: Self-efficacy
timeFrame: 1 year
measure: Primary Care Provider Attitudes
timeFrame: 1 year
Other outcomes:
Locations:
city: Seattle
country: United States
facility: Fred Hutchinson Cancer Research Center
state: Washington
Study officials:
affiliation: Fred Hutchinson Cancer Center
name: Eric Chow, MD, MPH
role: PRINCIPAL_INVESTIGATOR
References:
citation: Chow EJ, Chen Y, Armstrong GT, Baldwin LM, Cai CR, Gibson TM, Hudson MM, McDonald A, Nathan PC, Olgin JE, Syrjala KL, Tonorezos ES, Oeffinger KC, Yasui Y. Underdiagnosis and Undertreatment of Modifiable Cardiovascular Risk Factors Among Survivors of Childhood Cancer. J Am Heart Assoc. 2022 Jun 21;11(12):e024735. doi: 10.1161/JAHA.121.024735. Epub 2022 Jun 8.