Communicating Health Information and Improving Coordination With Primary Care

NCT03104543 | Completed Results DMC

• 5 other identifiers: 8543R01CA204378P30CA015704RG1001538NCI-2018-02637
• Study Type: interventional
• Target: 347
• Locations: 1 country
• Sites: 1

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. 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. 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. 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

Hypertension; Dyslipidemias; Diabetes; Childhood Cancer

Keywords

survivor; undertreatment; adherence; self-efficacy

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (3)

• Health Knowledge

  1 year

• Self-efficacy

  1 year

• Primary Care Provider Attitudes

  1 year

Study Arms (2)

Education

EXPERIMENTAL

Educational materials

Behavioral: Education

Test results

ACTIVE COMPARATOR

Test results only; with delayed access to the experimental materials

Behavioral: Test results only

Interventions

Education BEHAVIORAL

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

Education

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

Test results

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Fred Hutchinson Cancer Center: lead
• National Cancer Institute (NCI): collaborator
• St. Jude Children's Research Hospital: collaborator

Study Sites (1)

Fred Hutchinson Cancer Research Center

Seattle, Washington, 98109, United States

Location

Related Publications (1)

• 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.

  PMID: 35674343 DERIVED

MeSH Terms

Conditions

Hypertension; Dyslipidemias; Diabetes Mellitus; Neoplasms

Interventions

Educational Status

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases; Lipid Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Glucose Metabolism Disorders; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Socioeconomic Factors; Population Characteristics

Limitations and Caveats

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).

Results Point of Contact

• Title: Dr. Eric Chow
• Organization: Fred Hutchinson Cancer Center

ericchow@uw.edu

206-667-7724

Study Officials

• Eric Chow, MD, MPH

  Fred Hutchinson Cancer Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: Randomized clinical trial of an educational intervention

Study Record Dates

• First Submitted: March 23, 2017
• First Posted: April 7, 2017
• Study Start: March 1, 2017
• Primary Completion: December 1, 2022
• Study Completion: December 1, 2022
• Last Updated: March 6, 2024
• Results First Posted: January 22, 2024

Record last verified: 2024-02

Data Sharing

• IPD Sharing: Will share

Locations

US (1)