Heart and Blood Diseases

All Conditions

Nutritional and Metabolic Diseases

Gland and Hormone Related Diseases

Hypertension

Diabetes Mellitus

Dyslipidemias

Metabolic Diseases

Lipid Metabolism Disorders

Test results only; with delayed access to the experimental materials

30 minute education session; 15 minute booster session at 4 months

Education

The control group will receive a copy of test results upfront but not experimental educational materials; those will be available at 1 year

Test results only

Eric Chow, MD, MPH

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.

Randomized clinical trial of an educational intervention

Communicating Health Information and Improving Coordination With Primary Care

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

After study completion and analysis is completed, study data will join other CCSS data as a NCI-supported shared resource, available to approved external investigators.

Assess the overall probability of having any undertreated condition based on home visit measurements and blood testing

Childhood cancer survivors' self-reported health knowledge (measured by questionnaire)

Childhood cancer survivors' self-efficacy towards managing their healthcare (measured by questionnaire). Scale is based on work by: "Schwarzer R, Jerusalem M. Generalized Self-Efficacy scale. In: Weinman J, Wright S, Johnston M, editors. Measures in Health Psychology: A User's Portfolio. Casual and Control Beliefs. Windsor, UK:NFER-NELSON; 1995. p. 35-7." Specifically, the study used an adapted version of this scale with 5-items (4-point Likert scale) that measure perceived ability to set-goals, cope and recover from setbacks. The mean raw score for each participant was multiplied by 10 and converted to a T-score per survey developers' documentation, with 50 representing the US adult population mean, with a standard deviation of 10, and higher scores reflecting higher self-efficacy.

Healthcare providers' health knowledge and self-efficacy related to the care of childhood cancer survivors (measured by questionnaire). Specific question assesses providers' self-perceived skill in taking care of such survivors, rated from 1 (strongly disagree) to 5 (strongly agree).

National Cancer Institute (NCI)

St. Jude Children's Research Hospital

Fred Hutchinson Cancer Center

Professor

Educational materials

Education: 30 minute education session; 15 minute booster session at 4 months

Test results only; with delayed access to the experimental materials

Test results only: The control group will receive a copy of test results upfront but not experimental educational materials; those will be available at 1 year

Test Results

Total

Age, Continuous

Sex: Female, Male

White non-Hispanic

Other race/ethnicity

Race/Ethnicity, Customized

Undertreated hypertension

Undertreated dyslipidemia

Undertreated diabetes

New participant approaches ceased as of April 1, 2020 due to COVID-19 and inability to perform home examination visits. The study was paused until alternative study approaches were developed, with remaining subjects who had already been approached resuming baseline assessments using alternative methods starting October 2020. The final study participant had their baseline assessment completed May 2021 (n=347). Because of these delays, the study did not meet its original accrual goal (n=480).

Dr. Eric Chow

Number of participants with undertreated hypertension at follow-up

Number of participants with undertreated dyslipidemia at follow-up

Number of participants with undertreated prediabeties / diabetes at follow-up

Analysis population includes only those with 12 month follow-up data

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%)

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
Communicating Health Information and Improving Coordination With Primary Care	NCT03104543	Hypertension Dyslipidemias Diabetes Childhood Cance...	Education Test results on...	18 Years -	Fred Hutchinson Cancer Center
Communicating Health Information and Improving Coordination With Primary Care	NCT03104543	Hypertension Dyslipidemias Diabetes Childhood Cance...	Education Test results on...	18 Years -	Fred Hutchinson Cancer Center

Spots Global Cancer Trial Database for test results only