Evaluation of Cardiovascular Health Outcomes Among Survivors 2 (ECHOS2) Pilot Intervention: Translating ECHOS Into an mHealth Platform
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Enrollment
- 73
- Locations
- 1
- Primary Endpoint
- Change in health belief model (HBM) construct scale of knowledge about echocardiograms and the effects of their treatment on health
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Supportive Care
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Exclusion Criteria
- Not provided
Arms & Interventions
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.
Intervention: Computerized Intervention Authoring Software (CIAS) (Behavioral)
Outcomes
Primary Outcomes
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 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.
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.
Secondary Outcomes
- 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))
- Change in health belief model (HBM) construct scale intentions 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 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 worry about having heart problems(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(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(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(Through the second CIAS session (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 self-determination theory (SDT) construct scale of intrinsic motivation, defined by the perceived importance of getting an echocardiogram(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 number of sessions started/completed(Through the second CIAS session (expected to be about 1 week))