Using Health Information Technology to Improve Health Behaviors and Promote Cardiovascular Health Among Adolescent and Young Adult Cancer Survivors

Cardiovascular Disease Clinical Trial

Official title:

Using Health Information Technology to Improve Health Behaviors and Promote Cardiovascular Health Among Adolescent and Young Adult Cancer Survivors

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04623190
• Other study ID #: 202011075
• Status: Completed
• Phase: N/A
• Start date: June 23, 2021
• Est. completion date: March 25, 2022

Study information

• Verified date: August 2022
• Source: Washington University School of Medicine
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Health information technology (HIT) has the potential to improve the quality, efficiency, consistency, and availability of cancer survivor care. PREVENT is a novel HIT tool designed by our team for adolescents (12-19 years). PREVENT aggregates and displays the American Heart Association's (AHA) Life Simple 7 cardiovascular health (CVH) risk factors and provides tailored, evidence-based, behavior change recommendations inclusive of community resources that are delivered to overweight/obese adolescents at the point-of-care to improve CVH. The investigators seek to expand this tool for patients beyond 19 years of age to increase this tool's reach to the entire adolescent and young adult (AYA) age range and then evaluate its effectiveness among AYA cancer survivors.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 26
• Est. completion date: March 25, 2022
• Est. primary completion date: March 25, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 39 Years

Eligibility

Patient eligibility criteria

• Aged 20-39 years

• Prior diagnosis of pediatric cancer (diagnosed <21 years of age).

• Not receiving active therapy for their cancer

• Receiving care from the Pediatric Hematology/Oncology staff and physicians at St. Louis Children's Hospital, the St. Louis Children's Specialty Care Center, Siteman Cancer Center's Lifelong Outcomes Clinic at Siteman South County

• At risk for poor CVH (BMI = 25 kg/m^2)

• Ability to understand and willingness to sign an IRB approved written informed consent document (or that of legally authorized representative, if applicable).

Provider eligibility criteria.

-All providers and clinic staff (physicians, nurses, clinic staff, clinic research associates) in the Pediatric Hematology/Oncology program at St. Louis Children's Hospital and the CSCC or in the Siteman Cancer Center's Lifelong Outcomes Clinic at Siteman South County are eligible to participate.

Related Conditions & MeSH terms

• Cardiovascular Disease
• Cardiovascular Diseases
• Young Adult Cancer Survivors

Intervention

Behavioral:
• Wait-List Control
-Will receive routine clinical care. After completion of follow-up measures, control participants will receive a behavior change prescription via the PREVENT tool
• PREVENT tool
-PREVENT is a novel Health Information Technology tool designed to promote physical activity and healthy food intake among overweight/obese patients at the point of care. PREVENT automates the delivery of personalized, evidence-based behavior change recommendations and provides an interactive map of community resources to help providers link patients to resources in their community.

Locations

Country	Name	City	State
United States	Washington University School of Medicine	Saint Louis	Missouri

Sponsors (2)

Lead Sponsor	Collaborator
Washington University School of Medicine	American Cancer Society, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in minutes of physical activity	Physical activity will be measured using a triaxial accelerometer (Actigraph GT3X+, Actigraph of Ft. Walton Beach, FL). The participant will be instructed to wear the accelerometer on an elasticized belt, on the left mid-axillary line. The Actigraph is one of the most common accelerometers used for scientific purposes. Participants will be encouraged to wear the accelerometer 24-hours per day for at least 7-days, including 2 weekend days.	At baseline and 3-months
Primary	Change in food intake behaviors	Patient-reported food intake behaviors (fruit and vegetable intake, whole grains, sugar-sweetened beverages and snacking behaviors) are collected using a brief Health Behavior & Attitudes Survey.	At baseline and 3-months
Primary	Change in body mass index (BMI)	Collected from patient's medical record.	At baseline and 3-months
Primary	Change on patient's attitudes toward behavior change	A survey (6-question) administered to patients will assess attitudes toward and readiness for behavior change. Questions are asked using a 5-point Likert scale (range: 0-30) with a higher score indicating more positive attitudes.	At baseline and 3-months
Secondary	Change in patients' satisfaction of PREVENT tool: survey		Within 48 hours of clinic visit and at 3-months
Secondary	Provider's satisfaction of PREVENT tool: survey	A survey (15-questions) will assess provider's satisfaction with five aspects of health information technology: content, accuracy, format, ease of use and timeliness. Questions are asked on a 5-point Likert scale (range: 15-75) with a higher score indicating greater satisfaction	3-months
Secondary	Change on patient's average systolic and diastolic blood pressure	Collected from patient's medical record	At baseline and 3-months
Secondary	Change in patient's cholesterol	Collected from patient's medical record	At baseline and 3-months
Secondary	Change in patient's fasting blood glucose	Collected from patient's medical record	At baseline and 3-months
Secondary	Provider's motivation for sustained use of PREVENT tool	-A survey (12-questions) will assess provider's intent to change their behavior and continue using PREVENT were adapted from Legare's CPD Reaction Questionnaire. Questions are asked using a 7-point Likert scale (range: 12-84) with a higher score indicating greater motivation for sustained use.	3-months
Secondary	Fidelity of PREVENT tool implementation	-Fidelity will be measured using direct observation of patient-provider interactions while using the PREVENT tool. A direct observation checklist will be used by the observer to determine the number of interactions with the PREVENT tool that were implemented as intended.	0-3 months

External Links

•   Alvin J. Siteman Cancer Center at Barnes-Jewish Hospital and Washington University School of Medicine