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| ID | Type | Description | Link |
|---|---|---|---|
| R01CA204378 | U.S. NIH Grant/Contract | View source | |
| P30CA015704 | U.S. NIH Grant/Contract | View source | |
| RG1001538 | Other Identifier | Fred Hutch/University of Washington Cancer Consortium | |
| NCI-2018-02637 | Registry Identifier | CTRP (Clinical Trial Reporting Program) |
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| Name | Class |
|---|---|
| National Cancer Institute (NCI) | NIH |
| St. Jude Children's Research Hospital | OTHER |
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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:
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:
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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Education | Experimental | Educational materials |
|
| Test results | Active Comparator | Test results only; with delayed access to the experimental materials |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Education | Behavioral | 30 minute education session; 15 minute booster session at 4 months |
| |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | 1 year |
| Measure | Description | Time Frame |
|---|---|---|
| Health Knowledge | Childhood cancer survivors' self-reported health knowledge (measured by questionnaire) | 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Eric Chow, MD, MPH | Fred Hutchinson Cancer Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Fred Hutchinson Cancer Research Center | Seattle | Washington | 98109 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41642628 | Derived | 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. | |
| 35674343 | Derived | 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. |
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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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| ID | Title | Description |
|---|---|---|
| FG000 | Education | Educational materials Education: 30 minute education session; 15 minute booster session at 4 months |
| FG001 | Test Results | Test results only; with delayed access to the experimental materials 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 |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Education | Educational materials Education: 30 minute education session; 15 minute booster session at 4 months |
| BG001 | Test Results | Test results only; with delayed access to the experimental materials 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 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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 | Analysis population includes only those with 12 month follow-up data | Posted | Number | participants | 1 year |
|
1 year
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Education | Educational materials Education: 30 minute education session; 15 minute booster session at 4 months |
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New participant approaches ceased as of April 1, 2020 due to COVID-19 and inability to perform home examination visits. The study was paused until alternative study approaches were developed, with remaining subjects who had already been approached resuming baseline assessments using alternative methods starting October 2020. The final study participant had their baseline assessment completed May 2021 (n=347). Because of these delays, the study did not meet its original accrual goal (n=480).
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Eric Chow | Fred Hutchinson Cancer Center | 206-667-7724 | ericchow@uw.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jul 10, 2020 | Oct 17, 2023 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D006973 | Hypertension |
| D050171 | Dyslipidemias |
| D003920 | Diabetes Mellitus |
| D009369 | Neoplasms |
| ID | Term |
|---|---|
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D052439 | Lipid Metabolism Disorders |
| D008659 | Metabolic Diseases |
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| ID | Term |
|---|---|
| D004522 | Educational Status |
| ID | Term |
|---|---|
| D012959 | Socioeconomic Factors |
| D011154 | Population Characteristics |
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Randomized clinical trial of an educational intervention
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| Test results only |
| Behavioral |
The control group will receive a copy of test results upfront but not experimental educational materials; those will be available at 1 year |
|
| 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). | 1 year |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Count of Participants | Participants |
|
| Undertreated hypertension | Count of Participants | Participants |
|
| Undertreated dyslipidemia | Count of Participants | Participants |
|
| Undertreated diabetes | Count of Participants | Participants |
|
|
|
|
| Secondary | Health Knowledge | Childhood cancer survivors' self-reported health knowledge (measured by questionnaire) | Analysis population includes only those with 12 month follow-up data | Posted | Count of Participants | Participants | 1 year |
|
|
|
| Secondary | 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. | Analysis population includes only those with 12 month follow-up data | Posted | Mean | Standard Deviation | T-score | 1 year |
|
|
|
| Secondary | 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). | Number of primary care providers | Posted | Mean | Standard Deviation | units on a scale | 1 year |
|
|
|
|
| 5 |
| 175 |
| 0 |
| 175 |
| 0 |
| 175 |
| EG001 | Test Results | Test results only; with delayed access to the experimental materials 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 | 0 | 172 | 0 | 172 | 0 | 172 |
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| D009750 | Nutritional and Metabolic Diseases |
| D044882 | Glucose Metabolism Disorders |
| D004700 | Endocrine System Diseases |