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

August 24, 2022 updated by: Washington University School of Medicine
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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
26

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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.
At baseline and 3-months
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.
At baseline and 3-months
Change in body mass index (BMI)
Time Frame: At baseline and 3-months
Collected from patient's medical record.
At baseline and 3-months
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.
At baseline and 3-months

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
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-months
Change in patients' satisfaction of PREVENT tool: survey
Time Frame: Within 48 hours of clinic visit and at 3-months
Within 48 hours of clinic visit and at 3-months
Change on patient's average systolic and diastolic blood pressure
Time Frame: At baseline and 3-months
Collected from patient's medical record
At baseline and 3-months
Change in patient's cholesterol
Time Frame: At baseline and 3-months
Collected from patient's medical record
At baseline and 3-months
Change in patient's fasting blood glucose
Time Frame: At baseline and 3-months
Collected from patient's medical record
At baseline and 3-months
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.
3-months
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.
0-3 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Washington University School of Medicine

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
American Cancer Society, Inc.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
June 23, 2021

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
March 25, 2022

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
March 25, 2022

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
November 2, 2020

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 3, 2020

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
November 10, 2020

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
August 25, 2022

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 24, 2022

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
August 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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