Social Needs App for Oncology Patients Phase II

NCT06688513 | Enrolling By Invitation FDA Device

• 2 other identifiers: IRB00422975PD-S-0002-NIH-SBIR423
• Study Type: interventional
• Target: 722
• Locations: 1 country
• Sites: 3

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.

Conditions

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

Keywords

cancer; Social Support; Mobile Applications; Apps; Social Determinants of Health; SDH

Outcome Measures

Primary Outcomes (2)

• 30-day Readmission post-surgery

  30 Days

• Time to Social Determinants of Health Needs Addressed

  Time to event analysis of social determinants of health needs addressed from surgery

  90 Days

Study Arms (2)

Let's Talk: Sharing information about Family Cancer Risk

SHAM COMPARATOR

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

Carealth App

EXPERIMENTAL

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

Interventions

Carealth Phone App DEVICE

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.

Carealth App

Let's Talk: Sharing information about Family Cancer Risk BEHAVIORAL

An interactive tool that patients can use to learn about how to talk with their family members about the family member's cancer risk

Let's Talk: Sharing information about Family Cancer Risk

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• JHSPH Center for Clinical Trials: lead
• National Cancer Institute (NCI): collaborator

Study Sites (3)

Johns Hopkins University

Baltimore, Maryland, 21231, United States

Location

Northwell Health Cancer Institute

Lake Success, New York, 11042, United States

Location

The University of Tennessee Health Science Center

Memphis, Tennessee, 38163, United States

Location

MeSH Terms

Conditions

Neoplasms

Study Officials

• Lorraine Dean, ScD

  Johns Hopkins University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 18, 2024
• First Posted: November 14, 2024
• Study Start: October 1, 2024
• Primary Completion: July 1, 2025
• Study Completion: August 31, 2025
• Last Updated: November 14, 2024

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: Approximately 6 months after the end of the trial
• Access Criteria: Undecided

Locations

US (3)