Communicating Health Information and Improving Coordination With Primary Care (CHIIP)
Primary Purpose
Hypertension, Dyslipidemias, Diabetes
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Education
Test results only
Sponsored by
About this trial
This is an interventional supportive care trial for Hypertension focused on measuring survivor, undertreatment, adherence, self-efficacy
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.
Sites / Locations
- Fred Hutchinson Cancer Research Center
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Education
Test results
Arm Description
Educational materials
Test results only; with delayed access to the experimental materials
Outcomes
Primary Outcome Measures
Undertreatment of hypertension (>=140/90 mmHg), dyslipidemia (LDL >=160 mg/dL or triglyceride >=150 mg/dL), and/or diabetes (hemoglobin A1c >=7%)
Assess the overall probability of having any undertreated condition based on home visit measurements and blood testing
Secondary Outcome Measures
Health knowledge
Childhood cancer survivors' self-reported health knowledge (measured by questionnaire)
Self-efficacy
Childhood cancer survivors' self-efficacy towards managing their healthcare (measured by questionnaire)
Medication adherence
Survivors' adherence of cardiovascular and related medications (measured by questionnaire)
Primary care provider attitudes
Healthcare providers' health knowledge and self-efficacy related to the care of childhood cancer survivors (measured by questionnaire)
Full Information
NCT ID
NCT03104543
First Posted
March 23, 2017
Last Updated
December 12, 2022
Sponsor
Fred Hutchinson Cancer Center
Collaborators
National Cancer Institute (NCI), St. Jude Children's Research Hospital
1. Study Identification
Unique Protocol Identification Number
NCT03104543
Brief Title
Communicating Health Information and Improving Coordination With Primary Care
Acronym
CHIIP
Official Title
Communicating Health Information and Improving Coordination With Primary Care - an Ancillary Study of the Childhood Cancer Survivor Study
Study Type
Interventional
2. Study Status
Record Verification Date
December 2022
Overall Recruitment Status
Completed
Study Start Date
March 1, 2017 (Actual)
Primary Completion Date
December 1, 2022 (Actual)
Study Completion Date
December 1, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Fred Hutchinson Cancer Center
Collaborators
National Cancer Institute (NCI), St. Jude Children's Research Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. 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:
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hypertension, Dyslipidemias, Diabetes, Childhood Cancer
Keywords
survivor, undertreatment, adherence, self-efficacy
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Randomized clinical trial of an educational intervention
Masking
None (Open Label)
Allocation
Randomized
Enrollment
823 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Education
Arm Type
Experimental
Arm Description
Educational materials
Arm Title
Test results
Arm Type
Active Comparator
Arm Description
Test results only; with delayed access to the experimental materials
Intervention Type
Behavioral
Intervention Name(s)
Education
Intervention Description
30 minute education session; 15 minute booster session at 4 months
Intervention Type
Behavioral
Intervention Name(s)
Test results only
Intervention Description
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 Measure Information:
Title
Undertreatment of hypertension (>=140/90 mmHg), dyslipidemia (LDL >=160 mg/dL or triglyceride >=150 mg/dL), and/or diabetes (hemoglobin A1c >=7%)
Description
Assess the overall probability of having any undertreated condition based on home visit measurements and blood testing
Time Frame
1 year
Secondary Outcome Measure Information:
Title
Health knowledge
Description
Childhood cancer survivors' self-reported health knowledge (measured by questionnaire)
Time Frame
1 year
Title
Self-efficacy
Description
Childhood cancer survivors' self-efficacy towards managing their healthcare (measured by questionnaire)
Time Frame
1 year
Title
Medication adherence
Description
Survivors' adherence of cardiovascular and related medications (measured by questionnaire)
Time Frame
1 year
Title
Primary care provider attitudes
Description
Healthcare providers' health knowledge and self-efficacy related to the care of childhood cancer survivors (measured by questionnaire)
Time Frame
1 year
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Eric Chow, MD, MPH
Organizational Affiliation
Fred Hutchinson Cancer Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Fred Hutchinson Cancer Research Center
City
Seattle
State/Province
Washington
ZIP/Postal Code
98109
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing 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.
Citations:
PubMed Identifier
35674343
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.
Results Reference
derived
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Communicating Health Information and Improving Coordination With Primary Care
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