NCT06688513

Social Needs App for Oncology Patients Phase II

• Status: Enrolling By Invitation
• Phase: N/A
• Study type: Interventional
• Enrollment: 722 (estimated)
• Sponsor: JHSPH Center for Clinical Trials · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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.

Conditions

• Cancer
• Social Support (Formal and Informal)
• Mobile Application

Interventions

Type	Name	Description
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.
BEHAVIORAL	Let's Talk: Sharing information about Family Cancer Risk	An interactive tool that patients can use to learn about how to talk with their family members about the family member's cancer risk

Timeline

• Start date: 2024-10-01
• Primary completion: 2025-07-01
• Completion: 2025-08-31
• First posted: 2024-11-14
• Last updated: 2024-11-14

Locations

3 sites across 1 country: United States

Regulatory

• FDA-regulated device study