Social Needs App for Cancer

(SNAP-On II Trial)

Recruiting at 2 trial locations

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: JHSPH Center for Clinical Trials

Disqualifiers: CNS cancers, Upper extremity cancers

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 1

722 Participants Needed

Trial Summary

What is the purpose of this trial?

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.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It seems focused on using a mobile app to connect you with social resources, so it's unlikely to require changes to your medication.

What data supports the effectiveness of the Social Needs App treatment for cancer patients?

Research shows that addressing psychosocial needs and providing supportive care interventions can improve anxiety, depression, and quality of life in cancer patients. This suggests that tools like the Social Needs App, which aim to assess and address these needs, could be beneficial. ^{1 2 3 4 5}

Is the Social Needs App generally safe for use in humans?

The studies suggest that smartphone apps used in cancer treatment, like the Social Needs App, are designed to help manage symptoms and improve patient safety by allowing early detection and treatment of side effects. These apps have been tested in clinical settings and are considered safe for use in managing cancer treatment-related symptoms. ^{6 7 8 9 10}

How does the Social Needs App treatment differ from other treatments for cancer?

The Social Needs App is unique because it focuses on addressing the social support needs of cancer patients, particularly young adults, by facilitating peer-to-peer connections and communication with loved ones. Unlike traditional cancer treatments that target the disease itself, this app aims to improve emotional well-being and social interaction, which are often unmet needs in cancer care. ^{8 11 12 13 14}

Research Team

Lorraine Dean, ScD

Principal Investigator

Johns Hopkins University

Eligibility Criteria

This trial is for cancer patients over 18, who need surgery with an overnight hospital stay and have a low risk of complications. They must read English, access the internet on a device, and be willing to use the Carealth app. Excluded are those with upper extremity or central nervous system cancers that could hinder app usage.

Inclusion Criteria

I do not have any surgeries planned within the next 2 weeks.

I either have no signs of cancer spread, am in my first round of treatment for spread cancer, or expected to live 6 months or more.

I have been diagnosed with a specific type of cancer.

Exclusion Criteria

I have cancer in my upper body that makes it hard to use my phone or apps.

I have been diagnosed with a brain or spinal cord cancer.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Pre-surgery Assessment

Participants complete questions about their social needs in the Carealth app and are connected to resources if in the treatment group

Up to surgery date

1 visit (virtual)

Post-surgery Monitoring

Participants are monitored for 30-day readmission and missed visits, with reminders based on discharge instructions

90 days

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

• Social Needs App

Trial Overview The SNAP ON II study compares two groups: one uses the Carealth Phone App to connect with resources like housing and food support before surgery; the other group gets information about family cancer risks from a CDC tool.

Participant Groups

Group I: Carealth App Experimental Treatment 1 Intervention

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.

Group II: Let's Talk: Sharing information about Family Cancer Risk Placebo Group 1 Intervention

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.

Who Is Running the Clinical Trial?

JHSPH Center for Clinical Trials

Lead Sponsor

Trials

14

Recruited

11,200+

National Cancer Institute (NCI)

Collaborator

Trials

14,080

Recruited

41,180,000+

Findings from Research

In a study involving 356 cancer patients, the telephone caseworker (TCW) model showed a significant improvement in physical functioning at 3 months compared to usual care, suggesting potential benefits of this intervention.

Participants in the TCW model reported better communication with their healthcare team and were more likely to have their needs addressed, indicating that this model may help in managing psychosocial needs, although no overall intervention effect was observed.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Impact of two supportive care interventions on anxiety, depression, quality of life, and unmet needs in patients with nonlocalized breast and colorectal cancers. Girgis, A., Breen, S., Stacey, F., et al.[2022]

The BPSS app, designed to support breast cancer patients during chemotherapy, did not show significant improvements in anxiety, depression, or health literacy compared to patients who did not use the app, based on a study of 102 patients.

Despite the lack of improvement in psychological outcomes, the app effectively recorded a high number of side effects, revealing that medical staff often underestimated the severity of patients' symptoms, suggesting the app could enhance communication and care between patients and healthcare providers.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effectiveness of a Smartphone Application as a Support Tool for Patients Undergoing Breast Cancer Chemotherapy: A Randomized Controlled Trial. Handa, S., Okuyama, H., Yamamoto, H., et al.[2021]

The study aims to evaluate a smartphone application designed for real-time reporting of adverse events in cancer treatments, which could enhance early detection and management of side effects, ultimately improving patient safety and treatment outcomes.

The trial will involve 66 patients over six months, assessing the feasibility of the app and comparing the quality of life and therapy doses between those using the app and those receiving standard care, highlighting the importance of patient-reported symptoms in cancer treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Digitalization of adverse event management in oncology to improve treatment outcome-A prospective study protocol. Kestler, AMR., Kühlwein, SD., Kraus, JM., et al.[2021]

A scoping review of 10 studies involving cancer patients identified various predictors of adherence to mHealth apps, but no definitive predictor for increased app usage was established.

The review highlights the need for further research into usage patterns to enhance the design and effectiveness of mHealth interventions in cancer care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Predictors of Adherence to Cancer-Related mHealth Apps in Cancer Patients Undergoing Oncological or Follow-Up Treatment-A Scoping Review. Armbruster, C., Knaub, M., Farin-Glattacker, E., et al.[2023]

References

1. England pubmed.ncbi.nlm.nih.gov

Holistic needs assessment in brain cancer patients: A systematic review of available tools. [2019]

2. United States pubmed.ncbi.nlm.nih.gov

Impact of two supportive care interventions on anxiety, depression, quality of life, and unmet needs in patients with nonlocalized breast and colorectal cancers. [2022]

3. United States pubmed.ncbi.nlm.nih.gov

Randomized trial of coordinated psychosocial interventions based on patient self-assessments versus standard care to improve the psychosocial functioning of patients with cancer. [2022]

4. Australia pubmed.ncbi.nlm.nih.gov

Psychosocial concerns of cancer patients in Singapore. [2018]

5. United States pubmed.ncbi.nlm.nih.gov

Evaluation of psychometric properties of needs assessment tools in cancer patients: A systematic literature review. [2022]

6. United States pubmed.ncbi.nlm.nih.gov

Effectiveness of a Smartphone Application as a Support Tool for Patients Undergoing Breast Cancer Chemotherapy: A Randomized Controlled Trial. [2021]

7. United States pubmed.ncbi.nlm.nih.gov

Digitalization of adverse event management in oncology to improve treatment outcome-A prospective study protocol. [2021]

8. England pubmed.ncbi.nlm.nih.gov

Design of the functional requirements of a smartphone app for patients receiving oral antineoplastic agents: The e-OncoSalud® app. [2020]

9. United States pubmed.ncbi.nlm.nih.gov

Randomized Trial of a Smartphone Mobile App to Improve Symptoms and Adherence to Oral Therapy for Cancer. [2021]

10. Brazil pubmed.ncbi.nlm.nih.gov

Data collection instrument for hematological diseases in na outpatient setting: a validation study. [2021]

11. Switzerland pubmed.ncbi.nlm.nih.gov

'Let Me Know If There's Anything I Can Do for You', the Development of a Mobile Application for Adolescents and Young Adults (AYAs) with Cancer and Their Loved Ones to Reconnect after Diagnosis. [2022]

12. United States pubmed.ncbi.nlm.nih.gov

Integrating social care into gynecologic oncology: Identifying and addressing patient's social needs. [2023]

13. England pubmed.ncbi.nlm.nih.gov

Peer-to-peer connections: Perceptions of a social support app designed for young adults with cancer. [2020]

14. Switzerland pubmed.ncbi.nlm.nih.gov

Predictors of Adherence to Cancer-Related mHealth Apps in Cancer Patients Undergoing Oncological or Follow-Up Treatment-A Scoping Review. [2023]