Translating ECHOS2 Into an mHealth Platform

NCT05923242 | Completed

• 1 other identifier: 202305110
• Study Type: interventional
• Target: 73
• Locations: 1 country
• Sites: 1

Brief Summary

Childhood cancer survivors are at an increased risk of cardiac toxicity due to prior anti-cancer therapy. However, adherence to cardiac screening in this population remains low. This study aims to assess the feasibility of an mHealth motivational interviewing platform called Computerized Authoring Intervention Software (CIAS) in childhood cancer survivors. Participants will be recruited from the Childhood Cancer Survivorship Study.

Conditions

Childhood Cancer; Cardiac Toxicity; Pediatric Cancer

Keywords

Anthracyclines; cardiotoxic therapy; chest radiation; mHealth; childhood cancer survivor; motivational interviewing

Outcome Measures

Primary Outcomes (5)

• Change in health belief model (HBM) construct scale of knowledge about echocardiograms and the effects of their treatment on health

  Patients will be asked about their knowledge of echocardiograms and the effects of their treatment on health on a 3 point scale consisting of possible answers of yes, no, and "don't know", with "don't know" being scored as incorrect. The scoring will be the summary of correct responses.

  From baseline survey to post-test survey (expected to be about 1 week)

• Change in self-determination theory (SDT) construct scale of competence, defined by confidence in getting an echocardiogram

  Patients will be asked about their confidence in getting an echocardiogram on a Likert scale with multiple choice between 0 to 10 with 0 indicating not at all sure and 10 indicating extremely sure. Scores will range from 0 and 10 with a higher value indicating higher confidence.

  From baseline survey to post-test survey (expected to be about 1 week)

• Change in self-determination theory (SDT) construct scale of autonomy, defined by the perceived choice of getting an echocardiogram

  Patients will be asked about their perceived choice of getting an echocardiogram on a 5-point Likert scale with 1 indicating disagree strongly and 5 indicating agree strongly. Scores will range from 3 to 15 with a higher score indicating higher perceived choice.

  From baseline survey to post-test survey (expected to be about 1 week)

• Change in self-determination theory (SDT) construct scale of relatedness, as defined by the effect of social norms/influence on the patient's decision of getting echocardiogram

  Patients will be asked about the effects of social norms/influence on a 5-point Likert scale with 1 indicating disagree strongly and 5 indicating agree strongly. Scores will range from 6 to 30 with a higher score indicating more effect of social norms and influence on the patient's decision.

  From baseline survey to post-test survey (expected to be about 1 week)

• Change in movement toward screening

  Movement toward screening will consist of checking if patient made a plan to set an appointment with healthcare provider to discuss screening, made an appointment to discuss screening, had appointment to discuss screening, scheduled screening, or obtained screening, and if this plan changed between post-test survey and 1 month follow-up.

  From post-test survey to 1 month follow-up (expected to be about 1 month and 1 week)

Secondary Outcomes (12)

• Change in health belief model (HBM) construct scale of perceived risk of having heart problems

  From baseline survey to post-test survey (expected to be about 1 week)

• Change in health belief model (HBM) construct scale of perceived severity of having heart problems

  From baseline survey to post-test survey (expected to be about 1 week)

• Change in health belief model (HBM) construct scale of perceived barriers to getting echocardiogram

  From baseline survey to post-test survey (expected to be about 1 week)

• Change in health belief model (HBM) construct scale of perceived benefits of getting echocardiogram

  From baseline survey to post-test survey (expected to be about 1 week)

• Change in health belief model (HBM) construct scale of overall self-efficacy of getting echocardiogram

  From baseline survey to post-test survey (expected to be about 1 week)

Study Arms (1)

Computerized Intervention Authoring Software (CIAS)

EXPERIMENTAL

Participants will be provided with a link to begin the study following consent, and the link will direct the participants to a baseline survey. At the end of the survey, participants will be automatically redirected to Computerized Intervention Authoring Software (CIAS). Participants will be encouraged to complete 2 sessions in CIAS, approximately 1 week apart. After completing the second session, CIAS will automatically redirect the participants to a post-test survey. Approximately 30 days after completing the second session, participants will be invited to complete a 30 day follow-up survey.

Behavioral: Computerized Intervention Authoring Software (CIAS)

Interventions

Computerized Intervention Authoring Software (CIAS) BEHAVIORAL

CIAS is a web based intervention. The CIAS tool walks the participant through a Motivational Interviewing process whereby they think through the reasons for and against completing screening. CIAS makes use of an automated avatar (Emmi) who is programed to ask them questions and lead them through several topic areas related to screening. The CIAS pathways include options for participants to request a link of resources after they complete each session and for patients to request a list of the cancer treatments listed in their study records in order to confirm their understanding of their cancer history.

Computerized Intervention Authoring Software (CIAS)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• years of age or older
• Diagnosed with cancer at age 17 or younger
• or more years after completion of cancer therapy
• Receipt of cardiotoxic therapy (Any dose of anthracycline or 15 Gy chest radiation involving cardiac structures)
• No history of cardiomyopathy
• Have not received an echocardiogram in the past 5 years

Sponsors & Collaborators

• Washington University School of Medicine: lead
• St. Jude Children's Research Hospital: 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

Neoplasms; Cardiotoxicity

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Drug-Related Side Effects and Adverse Reactions; Chemically-Induced Disorders; Radiation Injuries; Wounds and Injuries

Study Officials

• Erika Waters, PhD, MPH

  Washington University School of Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 19, 2023
• First Posted: June 28, 2023
• Study Start: July 5, 2023
• Primary Completion: December 31, 2023
• Study Completion: December 31, 2023
• Last Updated: January 11, 2024

Record last verified: 2024-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)