Childhood CancerECHOS2NCT05923242
Translating ECHOS2 Into an mHealth Platform
A study testing Computerized Intervention Authoring Software (CIAS) in people with Childhood Cancer and Cardiac Toxicity, run by Washington University School of Medicine at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Childhood Cancer, Cardiac Toxicity, Pediatric Cancer
- What is being tested?
- Computerized Intervention Authoring Software (CIAS)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 73 participants
- Where
- 1 siteUnited States
- Study dates
- 5 Jul 2023to 31 Dec 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
United States1 site
Washington University School of Medicine
St Louis, Missouri, 63110
About this study
Official title: Evaluation of Cardiovascular Health Outcomes Among Survivors 2 (ECHOS2) Pilot Intervention: Translating ECHOS Into an mHealth Platform
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
- Being tested
- Computerized Intervention Authoring Software (CIAS)
- Keywords
- Anthracyclines, cardiotoxic therapy, chest radiation, mHealth, childhood cancer survivor, motivational interviewing
- Medical subject headings
- Neoplasms, Cardiotoxicity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Computerized Intervention Authoring Software (CIAS)Behavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: Computerized Intervention Authoring Software (CIAS) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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
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.
Measured: 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
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.
Measured: 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
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.
Measured: 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
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.
Measured: 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
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.
Measured: From baseline survey to post-test survey (expected to be about 1 week)
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.
Measured: From baseline survey to post-test survey (expected to be about 1 week)
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.
Measured: From baseline survey to post-test survey (expected to be about 1 week)
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.
Measured: From baseline survey to post-test survey (expected to be about 1 week)
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.
Measured: From baseline survey to post-test survey (expected to be about 1 week)
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.
Measured: Through the second CIAS session (expected to be about 1 week)
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.
Measured: Through the second CIAS session (expected to be about 1 week)
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.
Measured: Through the second CIAS session (expected to be about 1 week)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jun 2023
- Study start5 Jul 2023
- Primary completion31 Dec 2023
- Study completion31 Dec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Childhood CancerStudies of the same condition, open and under way.
- More trials run by Washington University School of MedicineThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 73 participants (actual)
Sponsor and investigators
- Lead sponsor
- Washington University School of Medicine
- Sponsor type
- University, hospital or other
- Collaborators
- St. Jude Children's Research Hospital
- Responsible party
- Sponsor
- Investigators
- Erika Waters, PhD, MPH, Principal investigator, Washington University School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05923242
- Sponsor's protocol ID
- 202305110
- Acronym
- ECHOS2
- Status last verified
- Jan 2024
- First submitted
- 19 Jun 2023
- Last updated
- 11 Jan 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Cardiovascular Health Outcomes Among Survivors 2 (ECHOS2) Pilot Intervention: Translating ECHOS Into an mHealth Platform
- ClinicalTrials.gov ID
- NCT05923242
- Acronym / sponsor ID
- ECHOS2 / 202305110
- Conditions
- Childhood Cancer, Cardiac Toxicity, Pediatric Cancer
- Keywords
- Anthracyclines, cardiotoxic therapy, chest radiation, mHealth, childhood cancer survivor, motivational interviewing
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 73 participants (actual)
- Lead sponsor
- Washington University School of MedicineUniversity, hospital or other
- Collaborators
- St. Jude Children's Research Hospital
- Study start
- 5 Jul 2023 (actual)
- Primary completion
- 31 Dec 2023 (actual)
- Study completion
- 31 Dec 2023 (actual)
- First posted
- 28 Jun 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Computerized Intervention Authoring Software (CIAS) | Experimental | Behavioral: Computerized Intervention Authoring Software (CIAS)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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Computerized Intervention Authoring Software (CIAS)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. | Behavioural | Computerized Intervention Authoring Software (CIAS) |
Primary outcome
Change in health belief model (HBM) construct scale of knowledge about echocardiograms and the effects of their treatment on health
Time frame: From baseline survey to post-test survey (expected to be about 1 week)
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
Time frame: From baseline survey to post-test survey (expected to be about 1 week)
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
Time frame: From baseline survey to post-test survey (expected to be about 1 week)
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
Time frame: From baseline survey to post-test survey (expected to be about 1 week)
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
Time frame: From post-test survey to 1 month follow-up (expected to be about 1 month and 1 week)
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.
12 secondary outcomes
Change in health belief model (HBM) construct scale of perceived risk of having heart problems
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: From baseline survey to post-test survey (expected to be about 1 week)
Change in health belief model (HBM) construct scale of worry about having heart problems
Time frame: From baseline survey to post-test survey (expected to be about 1 week)
Change in health belief model (HBM) construct scale intentions of getting echocardiogram
Time frame: From baseline survey to post-test survey (expected to be about 1 week)
Change in self-determination theory (SDT) construct scale of intrinsic motivation, defined by the perceived importance of getting an echocardiogram
Time frame: From baseline survey to post-test survey (expected to be about 1 week)
Change in self-determination theory (SDT) construct scale of intrinsic motivation, defined by decision-making readiness
Time frame: From baseline survey to post-test survey (expected to be about 1 week)
Implementation process outcome of engagement with the app as measured by the time spent on the app
Time frame: Through the second CIAS session (expected to be about 1 week)
Implementation process outcome of engagement with the app as measured by the number of modules started/completed
Time frame: Through the second CIAS session (expected to be about 1 week)
Implementation process outcome of engagement with the app as measured by the number of sessions started/completed
Time frame: Through the second CIAS session (expected to be about 1 week)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jan 2024.
- Alvin J. Siteman Cancer Center at Barnes-Jewish Hospital and Washington University School of MedicineLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Erika Waters, PhD, MPH principal investigator
Washington University School of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Computerized Intervention Authoring Software (CIAS) in people with Childhood Cancer and Cardiac Toxicity, run by Washington University School of Medicine at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Jan 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in health belief model (HBM) construct scale of knowledge about echocardiograms and the effects of their treatment on health (time frame: From baseline survey to post-test survey (expected to be about 1 week)). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Jan 2024.