N/A
N=347
Communicating Health Information and Improving Coordination With Primary Care
Hypertension · Dyslipidemias · Diabetes · Childhood Cancer
Bottom Line
View on ClinicalTrials.gov: NCT03104543 ↗Enrolled (actual)
347
Serious AEs
0.0%
Results posted
Jan 2024
Primary outcome: 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%) — 49; 59; 43; 41 participants — p=.05
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Education (Behavioral); Test results only (Behavioral)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Fred Hutchinson Cancer Center
- Primary completion
- Dec 2022
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| 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%) |
49; 59; 43; 41; 48; 54 | .05 |
| SECONDARY Health Knowledge |
51; 49; 105; 113 | — |
| SECONDARY Self-efficacy |
49.5; 50.5 | — |
| SECONDARY Primary Care Provider Attitudes |
3.37; 3.46 | .05 |
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.
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.
Data sourced from ClinicalTrials.gov (NCT03104543). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.