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Carotid Ultrasound: Irradiated and non-irradiated sides of the neck in long-term survivors of pediatric cancers who received unilateral radiation therapy involving the carotid artery as part of their treatment

Bilateral carotid ultrasound measurements: A test that uses sound waves to look at the blood vessels in the neck.

Carotid Ultrasound

Winston Huh, MD

The goal of this clinical research study is to find out if long-term survivors of childhood head or neck cancer, who received radiation therapy as part of the overall treatment plan, are at increased risk of thickening or blockage of the carotid arteries (the major blood vessels in the neck).

Researchers also want to find out if other medical conditions, such as high blood sugar, high blood cholesterol, or history of tobacco use may contribute to the thickening or blockage of the carotid arteries.

Some research shows that survivors of adult head or neck cancer, who received radiation therapy, are at increased risk for thickening or blockage of the carotid arteries, which may increase the risk for other medical conditions, such as stroke. Researchers want to learn about the possible risks of thickening or blockage of the carotid arteries in survivors of childhood head or neck cancer.

If you agree to take part in this study, researchers will see if there are any possible effects (thickening or blockage) of radiation therapy on your carotid arteries. This will be done by examining the test results from routine testing (mentioned below) that is normally done for your standard long-term follow-up care of the disease. These routine tests would be performed even if you were not in this research study.

During your long-term follow-up clinic appointment, you will have a physical exam and an ultrasound test (performed at the Cardiology Clinic) of the carotid arteries. A carotid ultrasound is a test that uses sound waves to look at the blood vessels in the neck. Blood will be drawn (about 2-3 teaspoons) for laboratory tests, including blood sugar level, blood cholesterol level, blood triglyceride level, thyroid hormone level, and blood levels of certain proteins (C-reactive protein and brain natriuretic peptide).

If any of the tests show any thickening or blockage of the carotid arteries or other medical problems, such as high blood sugar, your study doctor will discuss the test results, treatment options, and/or a follow-up plan with you.

This is an investigational study. Up to 60 patients will take part in this study. All will be enrolled at M. D. Anderson.

Carotid Artery Disease in Childhood Cancer Survivors

Carotid Artery Disease in Long-Term Survivors of Childhood Cancer

M.D. Anderson Cancer Center

I-Chan Huang, PhD

Survivors of childhood cancer often suffer treatment-related toxicities, including chronic health conditions, high symptom burden and emotional distress, and decremented functional status and quality of life. Although some patient-reported outcome (PRO) tools are available for survivors of childhood cancer younger than 18 years old, very few studies have been designed to evaluate longitudinal measurement properties of these PRO tools. In this study the investigators propose to recruit participants from a cohort of diverse childhood cancer survivors who were treated at St. Jude Children's Research Hospital (St. Jude) to improve assessment tools for PROs and health-related quality of life (HRQOL).

The purpose of this study is to measure the link between Patient Reported Outcome Measurement Information System (PROMIS) and clinical assessments of childhood cancer survivors over time. PROMIS is a questionnaire that measures patient-reported outcomes in adults and children.

The study plans to enroll 300 children. Surveys will be completed by the children and their parents/legal guardians (a total of 600 surveys).

PRIMARY OBJECTIVES:

1. To evaluate the longitudinal construct validity of the PROMIS Pediatric measures for childhood cancer survivors by testing the association of change in PROMIS PRO scores and the change in health status measured by objective clinical assessment. Age at baseline and sex will be included in the analysis.
2. To establish clinically meaningful classifications of the PROMIS Pediatric measures for childhood cancer survivors by referring PROMIS PRO scores to health status measured by clinical assessment. Age at baseline and sex will be included in the analysis.
3. To estimate the minimally important differences (MIDs) of the PROMIS Pediatric measures by referring to the change of health status evaluated by anchor-based anchors and patient-based anchors for childhood cancer survivors. Age at baseline and sex will be included in the analysis.

A longitudinal framework was designed to collect data from childhood cancer survivors (8-18.9 years of age) and parents of participating cancer survivors (i.e., dyads) when they visit the After Completion of Therapy (ACT) clinic at St. Jude in three consecutive years (approximately 1 year apart; T1, T2, and T3).

Participants will complete pediatric patient-reported outcomes (PRO) survey/questionnaires, a neurocognitive assessment and physical performance evaluation will be completed, and parental surveys will be conducted. In addition, any data collected as part of the SJLIFE protocol may also be used as part of this study.

1. The Pediatric PRO survey/questionnaires collection information on PROs. They include questions about general health, pain interference, fatigue, psychological stress experiences, stigma, sleep disturbance, sleep-related impairment, positive affect, meaning and purpose, depressive symptoms, anxiety, and physical function-mobility. Each cancer survivor will complete these during annual follow-up visits at three time points: years 1, 2 and 3. This process takes approximately 30-40 minutes.
2. Neurocognitive evaluation is done by tests given by a licensed or certified psychological examiner to evaluate how the participant processes information. The tests evaluate how problems are solved, how well information is remembered, how well the participant pays attention, how quickly they understand information, and their assessment of quality of life. The tests are commonly used standardized tests that take about 2 hours to complete.
3. Physical performance evaluation will measure heart and lung fitness, flexibility, mobility, muscle strength, endurance, balance and physical mobility. Testing takes about 2 hours to complete and includes six-minute walk test, walking speed test, muscle strength and flexibility, and balance.
4. The parental survey is a parent-report form (PRF) to be completed by parents/legal guardians of participants. Information collected on the PRF includes demographic information, parental quality of life, social support, family dynamics, parenting behaviors, and the child's health care utilization data. The child and parent data will be compared. Parental questionnaires will be completed at one time point, year 1, 2, or 3, and will take approximately 40 minutes to complete.

Validation Study of Pediatric Patient-Reported Outcomes

Pediatric Patient-Reported Outcomes (PEPR) for Childhood Cancer Survivors: Clinical Validity Study

The change of patient-reported outcome (PRO) between time points will be calculated.

National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)

Children's Hospital of Philadelphia

St. Jude Children's Research Hospital

Complete a self-report survey once over the telephone or by mail. The questions are about your health beliefs and behaviors, your current health, and your mood. It should not take longer than 45 minutes to complete. About 15 of these people will participate in an additional, short audiotaped interview about sun protection.

Questionnaire or Interview

Marie Barnett, PhD

The purpose of this study is to examine the health behaviors of young adults who have been treated for cancer, leukemia, or similar illnesses. We will also ask you some questions about your family members' and friends' health behaviors. We plan to use the findings from this study to design new programs to help teenage cancer survivors resist doing things that might harm their health.

This study proposes to explore cancer-risk behaviors and future behavioral intentions among adolescent cancer survivors (i.e., 14-19 years old) and compare them to their "healthy" peers using population-based normative data. Additionally, it seeks to determine the significant theory-driven covariates related to adolescent survivors' health behaviors, which will aid in the design of future behavioral interventions.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Carotid Artery Disease in Childhood Cancer Survivors	NCT00591539	Pediatric Cance...	Carotid Ultraso...	- 21 Years	M.D. Anderson Cancer Center
Carotid Artery Disease in Childhood Cancer Survivors	NCT00591539	Pediatric Cance...	Carotid Ultraso...	- 21 Years	M.D. Anderson Cancer Center
Validation Study of Pediatric Patient-Reported Outcomes	NCT03229837	Tumor Malignancy		8 Years - 18 Years	St. Jude Children's Research Hospital
Adolescent Survivors of Cancer or Similar Illnesses	NCT00579631	Adolescent Canc... Pediatric Cance...	Questionnaire o...	14 Years - 19 Years	Memorial Sloan Kettering Cancer Center
Carotid Artery Disease in Childhood Cancer Survivors	NCT00591539	Pediatric Cance...	Carotid Ultraso...	- 21 Years	M.D. Anderson Cancer Center

Spots Global Cancer Trial Database for pediatric cancer survivors