Communicating Health Information and Improving Coordination With Primary Care (CHIIP)

• ClinicalTrials.gov Identifier: NCT03104543
• Recruitment Status: Completed
• First Posted: April 7, 2017
• Last Update Posted: December 14, 2022
• Sponsor: Fred Hutchinson Cancer Center
• Collaborators: National Cancer Institute (NCI); St. Jude Children's Research Hospital
• Information provided by (Responsible Party): Fred Hutchinson Cancer Center

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Hypertension; Dyslipidemias; Diabetes; Childhood Cancer	Behavioral: Education; Behavioral: Test results only	Not Applicable

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.

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 823 participants
• Allocation: Randomized
• 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

Arms and Interventions

Arm	Intervention/treatment
Experimental: Education; Educational materials	Behavioral: Education; 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

Outcome Measures

Primary Outcome Measures :

1. 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

Secondary Outcome Measures :

1. Health knowledge [ Time Frame: 1 year ]
   Childhood cancer survivors' self-reported health knowledge (measured by questionnaire)
2. Self-efficacy [ Time Frame: 1 year ]
   Childhood cancer survivors' self-efficacy towards managing their healthcare (measured by questionnaire)
3. Medication adherence [ Time Frame: 1 year ]
   Survivors' adherence of cardiovascular and related medications (measured by questionnaire)
4. 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)

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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.

Contacts and Locations

Locations

United States, Washington

Fred Hutchinson Cancer Research Center

Seattle, Washington, United States, 98109

Sponsors and Collaborators

Fred Hutchinson Cancer Center

National Cancer Institute (NCI)

St. Jude Children's Research Hospital

Investigators

• Principal Investigator: Eric Chow, MD, MPH; Fred Hutchinson Cancer Center

More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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.

• Responsible Party: Fred Hutchinson Cancer Center
• ClinicalTrials.gov Identifier: NCT03104543
• Other Study ID Numbers: 8543; R01CA204378 ( U.S. NIH Grant/Contract ); P30CA015704 ( U.S. NIH Grant/Contract ); RG1001538 ( Other Identifier: Fred Hutch/University of Washington Cancer Consortium ); NCI-2018-02637 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
• First Posted: April 7, 2017
• Last Update Posted: December 14, 2022
• Last Verified: December 2022

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: Yes
• Plan Description: 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.

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Fred Hutchinson Cancer Center:

survivor; undertreatment; adherence; self-efficacy

Additional relevant MeSH terms:

Dyslipidemias; Lipid Metabolism Disorders; Metabolic Diseases