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OpenTrials
Completed

NCT Number: NCT04623190

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.

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Key information

Conditions

Cardiovascular Disease Cardiovascular Diseases Young Adult Cancer Survivors

Age range

20 year–39 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Washington University School of Medicine

St Louis, Missouri, 63110, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Wait-list control

Behavioral

-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

Behavioral

-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.

Primary outcomes

  1. Change in minutes of physical activity

    Time frame: At baseline and 3-months

    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.

  2. Change in food intake behaviors

    Time frame: At baseline and 3-months

    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.

  3. Change in body mass index (BMI)

    Time frame: At baseline and 3-months

    Collected from patient's medical record.

  4. Change on patient's attitudes toward behavior change

    Time frame: At baseline and 3-months

    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.

Secondary outcomes

  1. Change in patients' satisfaction of PREVENT tool: survey

    Time frame: Within 48 hours of clinic visit and at 3-months

  2. Provider's satisfaction of PREVENT tool: survey

    Time frame: 3-months

    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. Change on patient's average systolic and diastolic blood pressure

    Time frame: At baseline and 3-months

    Collected from patient's medical record

  4. Change in patient's cholesterol

    Time frame: At baseline and 3-months

    Collected from patient's medical record

  5. Change in patient's fasting blood glucose

    Time frame: At baseline and 3-months

    Collected from patient's medical record

  6. Provider's motivation for sustained use of PREVENT tool

    Time frame: 3-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.

  7. Fidelity of PREVENT tool implementation

    Time frame: 0-3 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.

Sponsors and collaborators

Lead sponsor

Washington University School of Medicine

Other

Collaborators

  • American Cancer Society, Inc.

Registry information

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Nov 10, 2020
Registry last updated
Aug 25, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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