HypertensionCHIIPNCT03104543
Communicating Health Information and Improving Coordination With Primary Care
A study testing Education and Test results only in people with Hypertension and Dyslipidemias, run by Fred Hutchinson Cancer Center at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hypertension, Dyslipidemias, Diabetes
- What is being tested?
- Education and Test results only
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 347 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Mar 2017to 1 Dec 2022
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Fred Hutchinson Cancer Research Center
Seattle, Washington, 98109
About this study
Official title: Communicating Health Information and Improving Coordination With Primary Care - an Ancillary Study of the Childhood Cancer Survivor Study
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.
Read the 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.
- Conditions
- Hypertension, Dyslipidemias, Diabetes, Childhood Cancer
- Being tested
- Education, Test results only
- Keywords
- survivor, undertreatment, adherence, self-efficacy
- Medical subject headings
- Hypertension, Dyslipidemias, Diabetes Mellitus, Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EducationBehavioural
30 minute education session; 15 minute booster session at 4 months
Test results onlyBehavioural
The control group will receive a copy of test results upfront but not experimental educational materials; those will be available at 1 year
| Study group | Role | What they receive |
|---|---|---|
| Education | Experimental | Educational materials Receives: Behavioral: Education |
| Test results | Active comparator | Test results only; with delayed access to the experimental materials Receives: Behavioral: Test results only |
What is being measured
The primary outcome is the main question the study is designed to answer.
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%)
Assess the overall probability of having any undertreated condition based on home visit measurements and blood testing
Measured: 1 year
Secondary outcomes (3)
Health Knowledge
Childhood cancer survivors' self-reported health knowledge (measured by questionnaire)
Measured: 1 year
Self-efficacy
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.
Measured: 1 year
Primary Care Provider Attitudes
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).
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Apr 2017
- Study start1 Mar 2017
- Primary completion1 Dec 2022
- Study completion1 Dec 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for HypertensionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized clinical trial of an educational intervention
- Masking
- None (open label)
- Enrolment
- 347 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fred Hutchinson Cancer Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Eric Chow, Fred Hutchinson Cancer Center
- Investigators
- Eric Chow, MD, MPH, Principal investigator, Fred Hutchinson Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03104543
- Sponsor's protocol ID
- 8543
- Other IDs
- R01CA204378, P30CA015704, RG1001538, NCI-2018-02637
- Acronym
- CHIIP
- Status last verified
- Feb 2024
- First submitted
- 23 Mar 2017
- Last updated
- 6 Mar 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.
Publications
Chow EJ, Chen Y, Yasui Y, Baldwin LM, Hudson MM, Muller TM, Nathan PC, Ngai SL, Ohlsen TJD, Snyder C, Syrjala KL, Tonorezos ES, Armstrong GT, Oeffinger KC. Counseling and Cardiovascular Disease Risk Factor Control in Long-Term Cancer Survivors: A Randomized Clinical Trial. JAMA Netw Open. 2026 Feb 2;9(2):e2555863. doi: 10.1001/jamanetworkopen.2025.55863.
PubMed 41642628Chow 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.
PubMed 35674343
Study at a glance
From the registry record, last updated by the sponsor on 6 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Communicating Health Information and Improving Coordination With Primary Care - an Ancillary Study of the Childhood Cancer Survivor Study
- ClinicalTrials.gov ID
- NCT03104543
- Acronym / sponsor ID
- CHIIP / 8543
- Conditions
- Hypertension, Dyslipidemias, Diabetes, Childhood Cancer
- Keywords
- survivor, undertreatment, adherence, self-efficacy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 347 participants (actual)
- Lead sponsor
- Fred Hutchinson Cancer CenterUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI), St. Jude Children's Research Hospital
- Study start
- 1 Mar 2017 (actual)
- Primary completion
- 1 Dec 2022 (actual)
- Study completion
- 1 Dec 2022 (actual)
- First posted
- 7 Apr 2017 (actual)
- Results
- Posted 22 Jan 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Randomized clinical trial of an educational intervention
| Arm | Type | Receives |
|---|---|---|
| Education | Experimental | Behavioral: EducationEducational materials |
| Test results | Active comparator | Behavioral: Test results onlyTest results only; with delayed access to the experimental materials |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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)
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Education30 minute education session; 15 minute booster session at 4 months | Behavioural | Education |
| Test results onlyThe control group will receive a copy of test results upfront but not experimental educational materials; those will be available at 1 year | Behavioural | Test results |
Primary outcome
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%)
Time frame: 1 year
Assess the overall probability of having any undertreated condition based on home visit measurements and blood testing
3 secondary outcomes
Health Knowledge
Time frame: 1 year
Self-efficacy
Time frame: 1 year
Primary Care Provider Attitudes
Time frame: 1 year
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Mar 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 41642628Chow EJ, Chen Y, Yasui Y, Baldwin LM, Hudson MM, Muller TM, Nathan PC, Ngai SL, Ohlsen TJD, Snyder C, Syrjala KL, Tonorezos ES, Armstrong GT, Oeffinger KC. Counseling and Cardiovascular Disease Risk Factor Control in Long-Term Cancer Survivors: A Randomized Clinical Trial. JAMA Netw Open. 2026 Feb 2;9(2):e2555863. doi: 10.1001/jamanetworkopen.2025.55863.
- Derived from this study: PubMed 35674343Chow 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.
- Individual participant dataSharing planned: Yes. 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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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Eric Chow, MD, MPH principal investigator
Fred Hutchinson Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Education and Test results only in people with Hypertension and Dyslipidemias, run by Fred Hutchinson Cancer Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 22 Jan 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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%) (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03104543, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Mar 2024.