Communicating Health Information and Improving Coordination With Primary Care (CHIIP)
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|ClinicalTrials.gov Identifier: NCT03104543|
Recruitment Status : Completed
First Posted : April 7, 2017
Last Update Posted : December 14, 2022
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:
- 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.
- 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.
- 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.
|Condition or disease||Intervention/treatment||Phase|
|Hypertension Dyslipidemias Diabetes Childhood Cancer||Behavioral: Education Behavioral: Test results only||Not Applicable|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||823 participants|
|Intervention Model:||Parallel Assignment|
|Intervention Model Description:||Randomized clinical trial of an educational intervention|
|Masking:||None (Open Label)|
|Primary Purpose:||Supportive Care|
|Official Title:||Communicating Health Information and Improving Coordination With Primary Care - an Ancillary Study of the Childhood Cancer Survivor Study|
|Actual Study Start Date :||March 1, 2017|
|Actual Primary Completion Date :||December 1, 2022|
|Actual Study Completion Date :||December 1, 2022|
30 minute education session; 15 minute booster session at 4 months
Active Comparator: Test results
Test results only; with delayed access to the experimental materials
Behavioral: 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
- Undertreatment of hypertension (>=140/90 mmHg), dyslipidemia (LDL >=160 mg/dL or triglyceride >=150 mg/dL), and/or diabetes (hemoglobin A1c >=7%) [ Time Frame: 1 year ]Assess the overall probability of having any undertreated condition based on home visit measurements and blood testing
- Health knowledge [ Time Frame: 1 year ]Childhood cancer survivors' self-reported health knowledge (measured by questionnaire)
- Self-efficacy [ Time Frame: 1 year ]Childhood cancer survivors' self-efficacy towards managing their healthcare (measured by questionnaire)
- Medication adherence [ Time Frame: 1 year ]Survivors' adherence of cardiovascular and related medications (measured by questionnaire)
- Primary care provider attitudes [ Time Frame: 1 year ]Healthcare providers' health knowledge and self-efficacy related to the care of childhood cancer survivors (measured by questionnaire)
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03104543
|United States, Washington|
|Fred Hutchinson Cancer Research Center|
|Seattle, Washington, United States, 98109|
|Principal Investigator:||Eric Chow, MD, MPH||Fred Hutchinson Cancer Center|