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

NCT04623190 | Completed DMC

• 1 other identifier: 202011075
• Study Type: interventional
• Target: 26
• Locations: 1 country
• Sites: 1

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.

Conditions

Cardiovascular Disease; Young Adult Cancer Survivors

Outcome Measures

Primary Outcomes (4)

• 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 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 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 Outcomes (7)

• Change in patients' satisfaction of PREVENT tool: survey

  Within 48 hours of clinic visit and at 3-months

• Provider's satisfaction of PREVENT tool: survey

  3-months

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

  At baseline and 3-months

• Change in patient's cholesterol

  At baseline and 3-months

• Change in patient's fasting blood glucose

  At baseline and 3-months

Study Arms (3)

Providers

EXPERIMENTAL

-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

Patients - Wait-List Control

ACTIVE COMPARATOR

* 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

Patients - PREVENT Tool

EXPERIMENTAL

* 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

Interventions

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

Patients - Wait-List Control

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.

Patients - PREVENT Tool; Providers

Eligibility Criteria

• Age: 20 Years - 39 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

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.

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• Washington University School of Medicine: lead
• American Cancer Society, Inc.: collaborator

Study Sites (1)

Washington University School of Medicine

St Louis, Missouri, 63110, United States

Location

Related Links

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

MeSH Terms

Conditions

Cardiovascular Diseases

Study Officials

• Maura Kepper, Ph.D.

  Washington University School of Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 2, 2020
• First Posted: November 10, 2020
• Study Start: June 23, 2021
• Primary Completion: March 25, 2022
• Study Completion: March 25, 2022
• Last Updated: August 25, 2022

Record last verified: 2022-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)