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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04623190
Enrollment
26
Registered
2020-11-10
Start date
2021-06-23
Completion date
2022-03-25
Last updated
2022-08-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cardiovascular Disease, Young Adult Cancer Survivors

Brief 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.

Interventions

BEHAVIORALWait-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

BEHAVIORALPREVENT 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.

Sponsors

American Cancer Society, Inc.
CollaboratorOTHER
Washington University School of Medicine
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
20 Years to 39 Years
Healthy volunteers
No

Inclusion criteria

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.

Design outcomes

Primary

MeasureTime frameDescription
Change in minutes of physical activityAt baseline and 3-monthsPhysical 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.
Change in food intake behaviorsAt baseline and 3-monthsPatient-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.
Change in body mass index (BMI)At baseline and 3-monthsCollected from patient's medical record.
Change on patient's attitudes toward behavior changeAt baseline and 3-monthsA 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.

Secondary

MeasureTime frameDescription
Change in patient's fasting blood glucoseAt baseline and 3-monthsCollected from patient's medical record
Change in patients' satisfaction of PREVENT tool: surveyWithin 48 hours of clinic visit and at 3-months
Fidelity of PREVENT tool implementation0-3 months-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.
Provider's motivation for sustained use of PREVENT tool3-months-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.
Provider's satisfaction of PREVENT tool: survey3-monthsA 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
Change on patient's average systolic and diastolic blood pressureAt baseline and 3-monthsCollected from patient's medical record
Change in patient's cholesterolAt baseline and 3-monthsCollected from patient's medical record

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 7, 2026