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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03104543
Recruitment Status : Completed
First Posted : April 7, 2017
Last Update Posted : December 14, 2022
Sponsor:
Collaborators:
National Cancer Institute (NCI)
St. Jude Children's Research Hospital
Information provided by (Responsible Party):
Fred Hutchinson Cancer Center

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.

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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

Resource links provided by the National Library of Medicine


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




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)



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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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.

Information from the National Library of Medicine

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


Locations
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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
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Principal Investigator: Eric Chow, MD, MPH Fred Hutchinson Cancer Center
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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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    Key Record Dates
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.

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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:
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Dyslipidemias
Lipid Metabolism Disorders
Metabolic Diseases