An interventional study of Carealth Phone App and Let's Talk: Sharing information about Family Cancer Risk in Cancer, Social Support (Formal and Informal) and Mobile Application, sponsored by JHSPH Center for Clinical Trials. Enrolling by invitation at 3 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-11-14.
Sponsored by JHSPH Center for Clinical Trials · Not applicable, Interventional, and Prevention
SNAP ON II is a two-arm, parallel-group, multi-center, randomized trial for patients diagnosed with cancer who are planning to undergo expected uncomplicated surgical intervention for their cancer. The study seeks to test whether a mobile app (developed by PistevoDecision) that identifies and connects patients to resources to meet their basic needs (e.g., housing, food, transportation, etc) ccan improve patient outcomes. Prior to their scheduled surgery, patients will download a mobile/web app that asks about their social needs. Then, the treatment group will be connected to community-based resources through FindHelp and the control group will receive access to the Centers for Disease Control tool called Lets Talk: Sharing Info About Your Family Cancer Risk.
The goal for this study is to assess Carealth app's ability to connect patients to resources to meet patient's identified Social Determinant of Health (SDH) needs, with the end goal of assessing reduction in 30-day readmission and missed visits by connecting patients to resources to meet their social needs in a way that enables them to receive care earlier or avoid complications. Additionally, we will integrating the collection of SDH data with Electronic Health Record (EHR) data, per the initiatives from the Centers for Medicare and Medicaid Services (CMS), the US Office of the National Coordinator for Health Information Technology, and private EHR organizations.
The central hypothesis is that the access to resources in the Carealth app is associated with reduced 30-day readmission when compared to access to the sham app. To test this hypothesis, we will conduct a randomized clinical trial at multiple clinical sites. Our primary aim is to determine the proportion of 30-day readmission in the Carealth app group versus the sham app group. Further, we hypothesize that the time to SDH needs being met, time from oncologic consultation to surgery, and likelihood of missed/rescheduled appointments in the first 90-days post surgery will be reduced in the Carealth app group compared to the sham app. Thus, our secondary aim is to compare these outcomes between groups.
JHSPH Center for Clinical Trials is the lead sponsor of 13 studies on the registry; 3 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Participants in the control group will complete questions about their SDH needs in the Carealth mobile app but will not have any helpful resources attached to it that meet these needs. Instead, as an attention control, control group participants will be sent to an interactive tool created and validated by the Centers for Disease Control called Let's Talk: Sharing Info About Your Family Cancer Risk. This is an interactive tool that patients can use to learn about how to talk with their family members about the family member's cancer risk.
Behavioral: Let's Talk: Sharing information about Family Cancer Risk
Participants in the treatment group will complete questions about their SDH needs in the Carealth app. Those with SDH needs will be referred to resources to meet those needs through Findhelp embedded into the app. Participants in the treatment group will complete this information pre-surgery, which will be considered a baseline measurement at the start of their participation in the trial. Participants in the treatment group will also receive reminders based on the post-surgery discharge instructions.
Device: Carealth Phone App
The goal for this study is to assess Carealth app's ability to connect patients to resources to meet patient's identified SDH needs, with the end goal of assessing reduction in 30-day readmission and missed visits by connecting patients to resources to meet their social needs in a way that enables them to receive care earlier or avoid complications.
An interactive tool that patients can use to learn about how to talk with their family members about the family member's cancer risk
30-day Readmission post-surgery
Time frame: 30 Days
Time to Social Determinants of Health Needs Addressed
Time to event analysis of social determinants of health needs addressed from surgery
Time frame: 90 Days
Plan to share: Yes — * Presentations at national scientific meetings: This will include scientific meetings where the content centers on SDHs. It will also include national meetings where content interest relates to cancer care and delivery care processes including the annual meetings of the American Society of Clinical Oncology. * Presentations at local conferences at Johns Hopkins University and other hospital partner sites: These will include departmental grand rounds and presentations at lecture series. * Presentations to local community groups focused on cancer patient needs, including patient advocacy groups associated with each partnering hospital. * We will also develop a tutorial session for presentation via webinars illustrating the technology and intended use, and final webinar presentations to the NCI Evaluation Panel.
Supporting information: Study protocol, Sap
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JHSPH Center for Clinical Trials