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

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.

Study Overview

• Status: Completed
• Conditions: Cardiovascular Disease; Young Adult Cancer Survivors
• Intervention / Treatment: Behavioral: PREVENT tool; Behavioral: Wait-List Control

• Study Type: Interventional
• Enrollment (Actual): 26
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Missouri
    • Saint Louis, Missouri, United States, 63110
      • Washington University School of Medicine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 39 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Providers; -All eligible providers will be sent questionnaires electronically to their email at baseline and follow-up. Providers will be invited to attend a training session to educate them on the PREVENT tool at baseline. The providers will be delivering the PREVENT tool.	Behavioral: 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.
Active Comparator: Patients - Wait-List Control; Complete questionnaires and accelerometry at baseline (administered electronically or by mail; accelerometers administered by mail). Following baseline measurement, patients will be randomized and attend their clinic visit. Follow-up measures will be administered 3-months and 6-months after the clinic visit electronically and by mail; A PREVENT action plan (behavior change prescription, community resources, and education) will be provided to the patient via email after the completion of the follow-up measurement.	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
Experimental: Patients - PREVENT Tool; Complete questionnaires and accelerometry at baseline (administered electronically or by mail; accelerometers administered by mail). Following baseline measurement, patients will be randomized and attend their clinic visit. Follow-up measures will be administered 3-months and 6-months after the clinic visit electronically and by mail; At the clinic visit, the provider will use PREVENT tool to discuss risk and deliver a tailored behavioral change plan inclusive of patient-centered community resources. PREVENT will calculate patient's overall risk for developing cardiovascular disease. Physical activity and food intake recommendations are tailored to current weight status and health behaviors using evidence-based recommendations.	Behavioral: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
Change in body mass index (BMI)	Collected from patient's medical record.	At baseline and 3-months
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
Change in patients' satisfaction of PREVENT tool: survey		Within 48 hours of clinic visit and at 3-months
Change on patient's average systolic and diastolic blood pressure	Collected from patient's medical record	At baseline and 3-months
Change in patient's cholesterol	Collected from patient's medical record	At baseline and 3-months
Change in patient's fasting blood glucose	Collected from patient's medical record	At baseline and 3-months
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
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

Collaborators and Investigators

• Sponsor: Washington University School of Medicine
• Collaborators: American Cancer Society, Inc.

Publications and helpful links

Helpful Links

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

Study record dates

Study Major Dates

• Study Start (Actual): June 23, 2021
• Primary Completion (Actual): March 25, 2022
• Study Completion (Actual): March 25, 2022

Study Registration Dates

• First Submitted: November 2, 2020
• First Submitted That Met QC Criteria: November 3, 2020
• First Posted (Actual): November 10, 2020

Study Record Updates

• Last Update Posted (Actual): August 25, 2022
• Last Update Submitted That Met QC Criteria: August 24, 2022
• Last Verified: August 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases
• Other Study ID Numbers: 202011075

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No