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Communicating Health Information and Improving Coordination With Primary Care

NCT03104543 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 347

Last updated 2024-03-06

Study results available
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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.

Conditions

Interventions

BEHAVIORAL

Education

30 minute education session; 15 minute booster session at 4 months

BEHAVIORAL

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

Sponsors & Collaborators

Principal Investigators

  • Eric Chow, MD, MPH · Fred Hutchinson Cancer Center

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-03-01
Primary Completion
2022-12-01
Completion
2022-12-01

Countries

  • United States

Study Locations

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Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03104543 on ClinicalTrials.gov