Clinical trial NCT06688513: Social Needs App for Oncology Patients Phase II
Official title: Social Needs App for Oncology Patients Phase II
Study type: INTERVENTIONAL
Overall status: ENROLLING_BY_INVITATION
Phase: NA
Conditions: Cancer
Social Support (Formal and Informal)
Mobile Application
Keywords: cancer
Social Support
Mobile Applications
Apps
Social Determinants of Health
SDH
Lead sponsor: JHSPH Center for Clinical Trials
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2024-11-14
Enrollment: 722
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief 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.

Eligibility criteria: Inclusion Criteria:

* 18 years or older
* ECOG Performance Status11 score of 2 or less
* Diagnosed with cancer (e.g., head and neck; lung; breast; genitourinary; pancreatic; gastrointestinal; gynecological)
* Requires surgery, with an overnight stay in the hospital, as part of the treatment for their cancer.
* Surgery is considered low risk of major complication, as determined by the surgeon.
* Must be in one of the following categories: 1) have no evidence or suspicion of metastatic disease at time of consult, 2) metastatic in first-line treatment, or 3) metastatic with a 6-month or greater survival expectancy
* Not scheduled for surgery within 2 weeks
* Able to read and respond in English
* Have access to a smartphone, tablet, computer, or other device with an internet connection and web browser, ability and willingness to download the Carealth app
* Able to provide consent to the study

Exclusion Criteria:

* Diagnosis of cancers in the central nervous system, as these patients may experience cognitive function changes pre- or post-diagnosis that might influence their ability to use the app
* Diagnosis of cancers of the upper extremities, as they may experience limited physical function that may make it challenging to use a mobile app

Primary outcomes:
measure: 30-day Readmission post-surgery
timeFrame: 30 Days
measure: Time to Social Determinants of Health Needs Addressed
timeFrame: 90 Days
Secondary outcomes:
Other outcomes:
Locations:
city: Baltimore
country: United States
facility: Johns Hopkins University
state: Maryland
city: Lake Success
country: United States
facility: Northwell Health Cancer Institute
state: New York
city: Memphis
country: United States
facility: The University of Tennessee Health Science Center
state: Tennessee
Study officials:
affiliation: Johns Hopkins University
name: Lorraine Dean, ScD
role: PRINCIPAL_INVESTIGATOR
References: