Childhood Cancer, Diabetes, Dyslipidemias, Hypertension
Conditions
Keywords
survivor, undertreatment, adherence, self-efficacy
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.
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.
Interventions
BEHAVIORALEducation
30 minute education session; 15 minute booster session at 4 months
BEHAVIORALTest 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
Sponsors
National Cancer Institute (NCI)
St. Jude Children's Research Hospital
Fred Hutchinson Cancer Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Intervention model description
Randomized clinical trial of an educational intervention
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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%) | 1 year | Assess the overall probability of having any undertreated condition based on home visit measurements and blood testing |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Health Knowledge | 1 year | Childhood cancer survivors' self-reported health knowledge (measured by questionnaire) |
| Self-efficacy | 1 year | 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. |
| Primary Care Provider Attitudes | 1 year | 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). |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Education Educational materials
Education: 30 minute education session; 15 minute booster session at 4 months | 175 |
| 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 | 172 |
| Total | 347 |
Baseline characteristics
| Characteristic | Education | Test Results | Total |
|---|---|---|---|
| Age, Continuous | 41.3 years STANDARD_DEVIATION 9.9 | 39.4 years STANDARD_DEVIATION 8.9 | 40.3 years STANDARD_DEVIATION 9.4 |
| Race/Ethnicity, Customized Other race/ethnicity | 29 Participants | 25 Participants | 54 Participants |
| Race/Ethnicity, Customized White non-Hispanic | 146 Participants | 147 Participants | 293 Participants |
| Sex: Female, Male Female | 89 Participants | 93 Participants | 182 Participants |
| Sex: Female, Male Male | 86 Participants | 79 Participants | 165 Participants |
| Undertreated diabetes | 22 Participants | 19 Participants | 41 Participants |
| Undertreated dyslipidemia | 79 Participants | 80 Participants | 159 Participants |
| Undertreated hypertension | 68 Participants | 55 Participants | 123 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 5 / 175 | 0 / 172 |
| other Total, other adverse events | 0 / 175 | 0 / 172 |
| serious Total, serious adverse events | 0 / 175 | 0 / 172 |
Outcome results
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
Time frame: 1 year
Population: Analysis population includes only those with 12 month follow-up data
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Education | 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%) | Number of participants with undertreated hypertension at follow-up | 49 participants |
| Education | 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%) | Number of participants with undertreated dyslipidemia at follow-up | 43 participants |
| Education | 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%) | Number of participants with undertreated prediabeties / diabetes at follow-up | 48 participants |
| Test Results | 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%) | Number of participants with undertreated hypertension at follow-up | 59 participants |
| Test Results | 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%) | Number of participants with undertreated dyslipidemia at follow-up | 41 participants |
| Test Results | 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%) | Number of participants with undertreated prediabeties / diabetes at follow-up | 54 participants |
p-value: 0.0595% CI: [0.67, 1.45]Generalized estimating equation
Secondary
Health Knowledge
Childhood cancer survivors' self-reported health knowledge (measured by questionnaire)
Time frame: 1 year
Population: Analysis population includes only those with 12 month follow-up data
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Education | Health Knowledge | Number participants who recalled prior anthracycline exposure correctly at follow-up | 51 Participants |
| Education | Health Knowledge | Number participants who recalled prior radiotherapy exposure correctly at follow-up | 105 Participants |
| Test Results | Health Knowledge | Number participants who recalled prior anthracycline exposure correctly at follow-up | 49 Participants |
| Test Results | Health Knowledge | Number participants who recalled prior radiotherapy exposure correctly at follow-up | 113 Participants |
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).
Time frame: 1 year
Population: Number of primary care providers
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Education | Primary Care Provider Attitudes | 3.37 units on a scale | Standard Deviation 1.23 |
| Test Results | Primary Care Provider Attitudes | 3.46 units on a scale | Standard Deviation 1.13 |
p-value: 0.0595% CI: [-0.47, 0.28]t-test, 2 sided
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.
Time frame: 1 year
Population: Analysis population includes only those with 12 month follow-up data
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Education | Self-efficacy | 49.5 T-score | Standard Deviation 11.8 |
| Test Results | Self-efficacy | 50.5 T-score | Standard Deviation 11.3 |