Clinical trial NCT05923242: Translating ECHOS2 Into an mHealth Platform
Official title: Evaluation of Cardiovascular Health Outcomes Among Survivors 2 (ECHOS2) Pilot Intervention: Translating ECHOS Into an mHealth Platform
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Childhood Cancer
Cardiac Toxicity
Pediatric Cancer
Keywords: Anthracyclines
cardiotoxic therapy
chest radiation
mHealth
childhood cancer survivor
motivational interviewing
Lead sponsor: Washington University School of Medicine
Sponsor class: OTHER
Collaborators: name: St. Jude Children's Research Hospital
First posted: 2023-06-28
Enrollment: 73
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

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.


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

Primary outcomes:
measure: Change in health belief model (HBM) construct scale of knowledge about echocardiograms and the effects of their treatment on health
timeFrame: From baseline survey to post-test survey (expected to be about 1 week)
measure: Change in self-determination theory (SDT) construct scale of competence, defined by confidence in getting an echocardiogram
timeFrame: From baseline survey to post-test survey (expected to be about 1 week)
measure: Change in self-determination theory (SDT) construct scale of autonomy, defined by the perceived choice of getting an echocardiogram
timeFrame: From baseline survey to post-test survey (expected to be about 1 week)
measure: 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
timeFrame: From baseline survey to post-test survey (expected to be about 1 week)
measure: Change in movement toward screening
timeFrame: From post-test survey to 1 month follow-up (expected to be about 1 month and 1 week)
Secondary outcomes:
measure: Change in health belief model (HBM) construct scale of perceived risk of having heart problems
timeFrame: From baseline survey to post-test survey (expected to be about 1 week)
measure: Change in health belief model (HBM) construct scale of perceived severity of having heart problems
timeFrame: From baseline survey to post-test survey (expected to be about 1 week)
measure: Change in health belief model (HBM) construct scale of perceived barriers to getting echocardiogram
timeFrame: From baseline survey to post-test survey (expected to be about 1 week)
measure: Change in health belief model (HBM) construct scale of perceived benefits of getting echocardiogram
timeFrame: From baseline survey to post-test survey (expected to be about 1 week)
measure: Change in health belief model (HBM) construct scale of overall self-efficacy of getting echocardiogram
timeFrame: From baseline survey to post-test survey (expected to be about 1 week)
measure: Change in health belief model (HBM) construct scale of worry about having heart problems
timeFrame: From baseline survey to post-test survey (expected to be about 1 week)
measure: Change in health belief model (HBM) construct scale intentions of getting echocardiogram
timeFrame: From baseline survey to post-test survey (expected to be about 1 week)
measure: Change in self-determination theory (SDT) construct scale of intrinsic motivation, defined by the perceived importance of getting an echocardiogram
timeFrame: From baseline survey to post-test survey (expected to be about 1 week)
measure: Change in self-determination theory (SDT) construct scale of intrinsic motivation, defined by decision-making readiness
timeFrame: From baseline survey to post-test survey (expected to be about 1 week)
measure: Implementation process outcome of engagement with the app as measured by the time spent on the app
timeFrame: Through the second CIAS session (expected to be about 1 week)
measure: Implementation process outcome of engagement with the app as measured by the number of modules started/completed
timeFrame: Through the second CIAS session (expected to be about 1 week)
measure: Implementation process outcome of engagement with the app as measured by the number of sessions started/completed
timeFrame: Through the second CIAS session (expected to be about 1 week)
Other outcomes:
Locations:
city: Saint Louis
country: United States
facility: Washington University School of Medicine
state: Missouri
Study officials:
affiliation: Washington University School of Medicine
name: Erika Waters, PhD, MPH
role: PRINCIPAL_INVESTIGATOR
References: