CancerSNAP-On IINCT06688513
Social Needs App for Oncology Patients Phase II
A study testing Carealth Phone App and Let's Talk: Sharing information about Family Cancer Risk in people with Cancer and Social Support (Formal and Informal), run by JHSPH Center for Clinical Trials at 3 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cancer, Social Support (Formal and Informal), Mobile Application
- What is being tested?
- Carealth Phone App and Let's Talk: Sharing information about Family Cancer Risk
- Type of treatment
- Medical device, Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 722 participants
- Where
- 3 sitesUnited States
- Study dates
- 1 Oct 2024to 31 Aug 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Show all 10Show fewer
- 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
Who cannot join
- 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
Trial locations and contacts
3 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States3 sites
Johns Hopkins University
Baltimore, Maryland, 21231
Northwell Health Cancer Institute
Lake Success, New York, 11042
The University of Tennessee Health Science Center
Memphis, Tennessee, 38163
About this study
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.
Read the 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.
- Being tested
- Carealth Phone App, Let's Talk: Sharing information about Family Cancer Risk
- Keywords
- cancer, Social Support, Mobile Applications, Apps, Social Determinants of Health, SDH
- Medical subject headings
- Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Carealth Phone AppDevice
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.
Let's Talk: Sharing information about Family Cancer RiskBehavioural
An interactive tool that patients can use to learn about how to talk with their family members about the family member's cancer risk
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Device: Carealth Phone App |
What is being measured
The primary outcome is the main question the study is designed to answer.
30-day Readmission post-surgery
Measured: 30 Days
Time to Social Determinants of Health Needs Addressed
Time to event analysis of social determinants of health needs addressed from surgery
Measured: 90 Days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Nov 2024
- Study start1 Oct 2024
- Primary completionJul 2025 (estimated)
- Study completion31 Aug 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 722 participants (estimated)
Sponsor and investigators
- Lead sponsor
- JHSPH Center for Clinical Trials
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Lorraine Dean, ScD, Principal investigator, Johns Hopkins University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06688513
- Sponsor's protocol ID
- IRB00422975
- Other IDs
- PD-S-0002-NIH-SBIR423
- Acronym
- SNAP-On II
- Status last verified
- Nov 2024
- First submitted
- 18 Oct 2024
- Last updated
- 14 Nov 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- 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.
Study at a glance
From the registry record, last updated by the sponsor on 14 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Social Needs App for Oncology Patients Phase II
- ClinicalTrials.gov ID
- NCT06688513
- Acronym / sponsor ID
- SNAP-On II / IRB00422975
- Keywords
- cancer, Social Support, Mobile Applications, Apps, Social Determinants of Health, SDH
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 722 participants (estimated)
- Lead sponsor
- JHSPH Center for Clinical TrialsUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- 1 Oct 2024 (actual)
- Primary completion
- Jul 2025 (estimated)
- Study completion
- 31 Aug 2025 (estimated)
- First posted
- 14 Nov 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Let's Talk: Sharing information about Family Cancer Risk | Sham comparator | Behavioral: Let's Talk: Sharing information about Family Cancer RiskParticipants 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. |
| Carealth App | Experimental | Device: Carealth Phone AppParticipants 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- 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.
Key exclusion criteria (2 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Carealth Phone AppThe 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. | Device | Carealth App |
| Let's Talk: Sharing information about Family Cancer RiskAn interactive tool that patients can use to learn about how to talk with their family members about the family member's cancer risk | Behavioural | Let's Talk: Sharing information about Family Cancer Risk |
Primary outcome
30-day Readmission post-surgery
Time frame: 30 Days
Time to Social Determinants of Health Needs Addressed
Time frame: 90 Days
Time to event analysis of social determinants of health needs addressed from surgery
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Nov 2024.
- Individual participant dataSharing planned: 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Lorraine Dean, ScD principal investigator
Johns Hopkins University
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Carealth Phone App and Let's Talk: Sharing information about Family Cancer Risk in people with Cancer and Social Support (Formal and Informal), run by JHSPH Center for Clinical Trials at 3 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: enrolling by invitation, as of the sponsor's last update on 14 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
30-day Readmission post-surgery (time frame: 30 Days). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Nov 2024.