Heart and Blood Diseases

All Conditions

Nutritional and Metabolic Diseases

Gland and Hormone Related Diseases

Hypertension

Diabetes Mellitus

Dyslipidemias

Metabolic Diseases

Lipid Metabolism Disorders

Test results only; with delayed access to the experimental materials

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

Education

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 only

Eric Chow, MD, MPH

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.

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.

Randomized clinical trial of an educational intervention

Communicating Health Information and Improving Coordination With Primary Care

Communicating Health Information and Improving Coordination With Primary Care - an Ancillary Study of the Childhood Cancer Survivor Study

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.

Assess the overall probability of having any undertreated condition based on home visit measurements and blood testing

Childhood cancer survivors' self-reported health knowledge (measured by questionnaire)

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.

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).

National Cancer Institute (NCI)

St. Jude Children's Research Hospital

Fred Hutchinson Cancer Center

Professor

Educational materials

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

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

Test Results

Total

Age, Continuous

Sex: Female, Male

White non-Hispanic

Other race/ethnicity

Race/Ethnicity, Customized

Undertreated hypertension

Undertreated dyslipidemia

Undertreated diabetes

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).

Dr. Eric Chow

Number of participants with undertreated hypertension at follow-up

Number of participants with undertreated dyslipidemia at follow-up

Number of participants with undertreated prediabeties / diabetes at follow-up

Analysis population includes only those with 12 month follow-up data

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 participants who recalled prior anthracycline exposure correctly at follow-up

Number participants who recalled prior radiotherapy exposure correctly at follow-up

Health Knowledge

Self-efficacy

Primary Care Provider Attitudes

Overall Study

Neoplasms

Rare Diseases

Carcinoma

Thyroid Neoplasms

Thyroid Diseases

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Endocrine System Diseases

Endocrine Gland Neoplasms

Head and Neck Neoplasms

Chronic Graft Versus Host Disease

Alexandru Irimie, PhD

The continuous increase of the incidence of the thyroid cancer in the last years has taken this neoplasia among the first 4 frequent cancers in the cancer registry of the Institute of Oncology "Prof.Ion Chiricuţă" from Cluj-Napoca (IOCN), with a total number of over 470 new cases per year, added to the other 3700 cases already being in the evidence of the Institute.

The radical treatment brings for a long term a compensated chronic drug induces mYxoedema with it's important side effects. Among these one can find the dislipidemia and the change of the high sensitive C reactive protein (hsCRP) serological value. In the last years, many epidemiological studies have confirmed the fact that the patients with a high serological value of the hsCRP present a higher risk for the coronary disease and heart attack.

Prospective studies developed in european countries and in USA have provided results that are related to the predictive value of the hsCRP determinations over the cardiovascular risk. Thus, hsCRP is an indirect risk factor for the coronary disease. The risk for cardiovascular disease is 2 to 7 times higher at the people with a high level of hsCRP comparing to ones with low levels; the increase of the hsCRP serological value can be determined several years before the clinical debut of the coronary disease.

The screening for this population group with a high risk can introduce in use the prevention of the cardiac pathology and change the approach to the monitoring of the patients with thyroid cancer. A selection protocol will be elaborated for the patients that will withdraw the hormone treatment by using recombinant thyroid stimulating hormone (TSH) or will have personalised monitoring algorithm, with a shortening of the hormone treatment withdrawal.

Although considered a rare type of cancer with an incidence under 6 cases for 100 000 persons, the thyroid carcinoma is the most frequent endocrine tumor. The incidence of this malignant disease has exponentially increased in the last decade, so that many specially centers in the world have focused on a better strategy of diagnosis, of treatment and of monitoring. By applying a suitable multimodal treatment, the prognosis of this disease is excellent, offering the patients a survival rate of over 90% at 10 years. During the monitoring of the disease, the patients are periodically supposed to withdraw the hormone treatment; because of this hormone imbalance, there will be important changes of the metabolism, especially the lipid one. This is the reason why we are preoccupied to increase the quality of life of the patients addicted to a chronic thyroid hormone therapy. The aim of this study is to demonstrate the way in which the lipid profile is influenced and to quantify the cardiovascular risk for the patients radically treated of thyroid cancer, by total thyroidectomy, metabolic irradiation and undergoing a chronic thyroid hormone treatment. Nowadays, Romania is one of the countries in which these patients are supposed to be kept in a iatrogenous myxoedema, the alternative being the recombinant thyroid stimulating hormone. For the patients with the mentioned diagnosis, the lipid profile will be determined and will consist of the following: total serologic cholesterol, cholesterol fractions, triglycerides and C reactive protein highly sensitive (hsCRP). A score for the cardiovascular accident risk will be elaborated. The attempt of classifying in cardiovascular risk groups the patients through the present study, would facilitate the selection of the patients and their access to therapies and modern monitoring strategies.

Lipid Metabolic Status in Thyroid Carcinoma

"Evaluation of Lipid Metabolic Status and of Cardiovascular Risk at Patients With Thyroid Carcinoma, Radically Treated and With Chronic Thyroid Hormonal Substitution"

hsCRP in thyroid hormone withdrwal for patients with thyroid carcinoma radically treated

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Communicating Health Information and Improving Coordination With Primary Care	NCT03104543	Hypertension Dyslipidemias Diabetes Childhood Cance...	Education Test results on...	18 Years -	Fred Hutchinson Cancer Center
Communicating Health Information and Improving Coordination With Primary Care	NCT03104543	Hypertension Dyslipidemias Diabetes Childhood Cance...	Education Test results on...	18 Years -	Fred Hutchinson Cancer Center
Lipid Metabolic Status in Thyroid Carcinoma	NCT01487057	Thyroid Carcino... Dyslipidemias Risk Reduction ... Hormone Replace...		18 Years - 80 Years	Prof. Dr. I. Chiricuta Institute of Oncology

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