Back to resultsTranslating ECHOS2 Into an mHealth Platform (ECHOS2)
Primary Purpose
Childhood Cancer, Cardiac Toxicity, Pediatric Cancer
Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Computerized Intervention Authoring Software (CIAS)
Sponsored by
About this trial
This is an interventional supportive care trial for Childhood Cancer focused on measuring Anthracyclines, cardiotoxic therapy, chest radiation, mHealth, childhood cancer survivor, motivational interviewing
Eligibility Criteria
Inclusion Criteria: 18 years of age or older Diagnosed with cancer at age 17 or younger 2 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
Sites / Locations
- Washington University School of MedicineRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Computerized Intervention Authoring Software (CIAS)
Arm Description
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.
Outcomes
Primary Outcome Measures
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.
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.
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.
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.
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.
Secondary Outcome Measures
Change in health belief model (HBM) construct scale of perceived risk of having heart problems
Patients will be asked about their perceived risk of having heart problems on a 5 point scale, with 1 indicating no likelihood of heart problems, and 5 indicating extremely likely. Scores will range from 1 to 5 with a higher score indicating more perceived risk.
Change in health belief model (HBM) construct scale of perceived severity of having heart problems
Patients will be asked about their perceived severity of heart problems on a 5 point scale, with 1 indicating not serious and 5 indicating extremely serious. Scores will range from 1 to 5 with a higher score indicating higher perceived severity.
Change in health belief model (HBM) construct scale of perceived barriers to getting echocardiogram
Patients will be asked about their perceived barriers to getting an echocardiogram 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 fewer perceived barriers.
Change in health belief model (HBM) construct scale of perceived benefits of getting echocardiogram
Patients will be asked about their perceived benefits of getting an echocardiogram 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 perceived benefits.
Change in health belief model (HBM) construct scale of overall self-efficacy of getting echocardiogram
Patients will be asked about their overall self-efficacy 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 overall self-efficacy.
Change in health belief model (HBM) construct scale of worry about having heart problems
Patients will be asked about their worry about having heart problems on a 5-point scale with 1 indicating not worried at all and 5 indicating extremely worried. Scores will range from 1 to 5 with a higher score indicating more worry.
Change in health belief model (HBM) construct scale intentions of getting echocardiogram
Patients will be asked about their intentions 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 a higher intention of getting an echocardiogram.
Change in self-determination theory (SDT) construct scale of intrinsic motivation, defined by the perceived importance of getting an echocardiogram
Patients will be asked about their perceived importance of getting an echocardiogram on both a Likert scale with multiple choice between 0 to 10 with 0 indicating not at all important and 10 indicating extremely important, and a 5-point Likert scale with 1 indicating disagree strongly and 5 indicating agree strongly. Scores will range from 8 to 50 with a higher value indicating higher perceived importance.
Change in self-determination theory (SDT) construct scale of intrinsic motivation, defined by decision-making readiness
Patients will be asked about their decision-making readiness in getting an echocardiogram on a Likert scale with multiple choice between 0 to 10 with 0 indicating not at all ready and 10 indicating extremely ready. Scores will range from 0 to 10 with a higher score indicating higher decision-making readiness.
Implementation process outcome of engagement with the app as measured by the time spent on the app
This will be defined as the total time spent on the app during session 1 and session 2.
Implementation process outcome of engagement with the app as measured by the number of modules started/completed
This will be defined as the total number of modules started and total number of modules completed on the app during session 1 and session 2.
Implementation process outcome of engagement with the app as measured by the number of sessions started/completed
This will be defined as the total number of sessions started and total number of sessions completed on the app during session 1 and session 2.
Full Information
NCT ID
NCT05923242
First Posted
June 19, 2023
Last Updated
July 6, 2023
Sponsor
Washington University School of Medicine
Collaborators
St. Jude Children's Research Hospital
1. Study Identification
Unique Protocol Identification Number
NCT05923242
Brief Title
Translating ECHOS2 Into an mHealth Platform
Acronym
ECHOS2
Official Title
Evaluation of Cardiovascular Health Outcomes Among Survivors 2 (ECHOS2) Pilot Intervention: Translating ECHOS Into an mHealth Platform
Study Type
Interventional
2. Study Status
Record Verification Date
July 2023
Overall Recruitment Status
Recruiting
Study Start Date
July 5, 2023 (Actual)
Primary Completion Date
January 7, 2024 (Anticipated)
Study Completion Date
January 7, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Washington University School of Medicine
Collaborators
St. Jude Children's Research Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Childhood Cancer, Cardiac Toxicity, Pediatric Cancer
Keywords
Anthracyclines, cardiotoxic therapy, chest radiation, mHealth, childhood cancer survivor, motivational interviewing
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
50 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Computerized Intervention Authoring Software (CIAS)
Arm Type
Experimental
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Computerized Intervention Authoring Software (CIAS)
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change in health belief model (HBM) construct scale of knowledge about echocardiograms and the effects of their treatment on health
Description
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.
Time Frame
From baseline survey to post-test survey (expected to be about 1 week)
Title
Change in self-determination theory (SDT) construct scale of competence, defined by confidence in getting an echocardiogram
Description
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.
Time Frame
From baseline survey to post-test survey (expected to be about 1 week)
Title
Change in self-determination theory (SDT) construct scale of autonomy, defined by the perceived choice of getting an echocardiogram
Description
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.
Time Frame
From baseline survey to post-test survey (expected to be about 1 week)
Title
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
Description
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.
Time Frame
From baseline survey to post-test survey (expected to be about 1 week)
Title
Change in movement toward screening
Description
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.
Time Frame
From post-test survey to 1 month follow-up (expected to be about 1 month and 1 week)
Secondary Outcome Measure Information:
Title
Change in health belief model (HBM) construct scale of perceived risk of having heart problems
Description
Patients will be asked about their perceived risk of having heart problems on a 5 point scale, with 1 indicating no likelihood of heart problems, and 5 indicating extremely likely. Scores will range from 1 to 5 with a higher score indicating more perceived risk.
Time Frame
From baseline survey to post-test survey (expected to be about 1 week)
Title
Change in health belief model (HBM) construct scale of perceived severity of having heart problems
Description
Patients will be asked about their perceived severity of heart problems on a 5 point scale, with 1 indicating not serious and 5 indicating extremely serious. Scores will range from 1 to 5 with a higher score indicating higher perceived severity.
Time Frame
From baseline survey to post-test survey (expected to be about 1 week)
Title
Change in health belief model (HBM) construct scale of perceived barriers to getting echocardiogram
Description
Patients will be asked about their perceived barriers to getting an echocardiogram 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 fewer perceived barriers.
Time Frame
From baseline survey to post-test survey (expected to be about 1 week)
Title
Change in health belief model (HBM) construct scale of perceived benefits of getting echocardiogram
Description
Patients will be asked about their perceived benefits of getting an echocardiogram 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 perceived benefits.
Time Frame
From baseline survey to post-test survey (expected to be about 1 week)
Title
Change in health belief model (HBM) construct scale of overall self-efficacy of getting echocardiogram
Description
Patients will be asked about their overall self-efficacy 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 overall self-efficacy.
Time Frame
From baseline survey to post-test survey (expected to be about 1 week)
Title
Change in health belief model (HBM) construct scale of worry about having heart problems
Description
Patients will be asked about their worry about having heart problems on a 5-point scale with 1 indicating not worried at all and 5 indicating extremely worried. Scores will range from 1 to 5 with a higher score indicating more worry.
Time Frame
From baseline survey to post-test survey (expected to be about 1 week)
Title
Change in health belief model (HBM) construct scale intentions of getting echocardiogram
Description
Patients will be asked about their intentions 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 a higher intention of getting an echocardiogram.
Time Frame
From baseline survey to post-test survey (expected to be about 1 week)
Title
Change in self-determination theory (SDT) construct scale of intrinsic motivation, defined by the perceived importance of getting an echocardiogram
Description
Patients will be asked about their perceived importance of getting an echocardiogram on both a Likert scale with multiple choice between 0 to 10 with 0 indicating not at all important and 10 indicating extremely important, and a 5-point Likert scale with 1 indicating disagree strongly and 5 indicating agree strongly. Scores will range from 8 to 50 with a higher value indicating higher perceived importance.
Time Frame
From baseline survey to post-test survey (expected to be about 1 week)
Title
Change in self-determination theory (SDT) construct scale of intrinsic motivation, defined by decision-making readiness
Description
Patients will be asked about their decision-making readiness in getting an echocardiogram on a Likert scale with multiple choice between 0 to 10 with 0 indicating not at all ready and 10 indicating extremely ready. Scores will range from 0 to 10 with a higher score indicating higher decision-making readiness.
Time Frame
From baseline survey to post-test survey (expected to be about 1 week)
Title
Implementation process outcome of engagement with the app as measured by the time spent on the app
Description
This will be defined as the total time spent on the app during session 1 and session 2.
Time Frame
Through the second CIAS session (expected to be about 1 week)
Title
Implementation process outcome of engagement with the app as measured by the number of modules started/completed
Description
This will be defined as the total number of modules started and total number of modules completed on the app during session 1 and session 2.
Time Frame
Through the second CIAS session (expected to be about 1 week)
Title
Implementation process outcome of engagement with the app as measured by the number of sessions started/completed
Description
This will be defined as the total number of sessions started and total number of sessions completed on the app during session 1 and session 2.
Time Frame
Through the second CIAS session (expected to be about 1 week)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
18 years of age or older
Diagnosed with cancer at age 17 or younger
2 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Erika Waters, PhD, MPH
Phone
314-747-5705
Email
waterse@wustl.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Julia Maki, PhD
Phone
314-286-2835
Email
jmaki@wustl.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Erika Waters, PhD, MPH
Organizational Affiliation
Washington University School of Medicine
Official's Role
Principal Investigator
Facility Information:
Facility Name
Washington University School of Medicine
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63110
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Erika Waters, PhD, MPH
Phone
314-747-5705
Email
waterse@wustl.edu
First Name & Middle Initial & Last Name & Degree
Erika Waters, PhD, MPH
First Name & Middle Initial & Last Name & Degree
Melissa Hudson, MD
First Name & Middle Initial & Last Name & Degree
Matt Ehrhardt, MD
12. IPD Sharing Statement
Plan to Share IPD
No
Links:
URL
http://www.siteman.wustl.edu
Description
Alvin J. Siteman Cancer Center at Barnes-Jewish Hospital and Washington University School of Medicine
Learn more about this trial
Translating ECHOS2 Into an mHealth Platform
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