STOMA Care App for Colorectal Cancer Ostomy Support

(MORE Trial)

Overseen By Talia Korn

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Icahn School of Medicine at Mount Sinai

Disqualifiers: Metastatic cancer, Cancer recurrence, others

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

Compensation: Varies

Number of Visits: 3

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new web-based app called STOMA Care, designed to assist individuals about to undergo ostomy surgery due to bladder or colorectal cancer, along with their caregivers. The researchers aim to determine how this app can improve knowledge about stoma care, boost confidence in managing the stoma, and enhance overall quality of life. The trial will compare participants using the app with those receiving usual care without it. Ideal participants are those scheduled for ostomy surgery, who have a caregiver willing to join, and have access to a phone.

As an unphased trial, this study offers participants the chance to contribute to innovative research that could significantly improve stoma care education and support.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications.

What prior data suggests that the STOMA Care app is safe for patients and caregivers?

Research has shown that the STOMA Care app is generally safe for patients. Studies indicate that these apps can improve patient health without causing harm. Many patients report satisfaction and an improved quality of life when using them. One study found that telemedicine, such as the STOMA Care app, is as safe and effective as in-person doctor visits for people with colostomies. Overall, the app appears well-received, with no major safety issues reported so far. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the STOMA Care app because it offers a new way to support patients with colorectal cancer who have ostomies. Unlike the standard care, which relies on in-person clinic visits for ostomy support, this app provides a convenient, web-based option that patients and caregivers can access anytime. By using digital surveys and feedback tools, it aims to personalize care and potentially improve patients' quality of life more efficiently. This innovative approach could change how ostomy care is delivered, making it more accessible and tailored to individual needs.

What evidence suggests that the STOMA Care app is effective for colorectal cancer ostomy support?

This trial will compare the STOMA Care app with usual care for colorectal cancer ostomy support. Studies have shown that the STOMA Care app can greatly improve the quality of life for people with stomas. Specifically, one study found a 3.1-point improvement in stoma-related quality of life after using the app for just one month. Research also shows that mobile apps for stoma care help patients recover better after hospital discharge. The app boosts users' confidence and skills in managing their stoma at home. Overall, patients generally find the app useful and are satisfied with it. ^{1 2 3 6 7}

Who Is on the Research Team?

Nihal Mohamed, PhD

Principal Investigator

Icahn School of Medicine at Mount Sinai

Are You a Good Fit for This Trial?

This trial is for bladder or colorectal cancer patients aged 21+ who are about to have ostomy surgery and can use a phone. They must understand English and be mentally fit to consent. A family caregiver over 21 must also join the study. People with metastatic or recurrent cancer, other cancers, or those not fluent in English cannot participate.

Inclusion Criteria

I am having surgery for an ostomy due to bladder or colorectal cancer.

Access to a phone

I am 21 years old or older.

Exclusion Criteria

My cancer has spread, come back, or I have more than one type of cancer.

I cannot speak, read, or write in English.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Pre-Surgery Preparation

Participants and caregivers are introduced to the STOMA Care app and prepare for ostomy surgery

1 week

1 visit (in-person)

Post-Surgery Treatment

Participants and caregivers use the STOMA Care app to enhance knowledge, skills, and self-regulation post-surgery

4 weeks

2 visits (in-person), ongoing app usage

Follow-up

Participants are monitored for safety, effectiveness, and quality of life improvements after using the STOMA Care app

5 weeks

What Are the Treatments Tested in This Trial?

Interventions

• STOMA Care

Trial Overview The study tests a 'STOMA Care' web app against usual care for ostomy patients and their caregivers. It looks at how well the app works in improving knowledge, skills, confidence in stoma care, as well as emotional wellbeing and quality of life after surgery.

How Is the Trial Designed?

Group I: STOMA Care Experimental Treatment 1 Intervention

Patients and the caregivers accessing the full MORE program on the secured Website. The patients and caregivers will be instructed on how to complete the 1 week (or upon discharge) and 4 week surveys via REDCap or through the RC. This group has additional requirements in the 4-week survey to assess the helpfulness of the Stoma Care app.

Group II: Usual Care Active Control 1 Intervention

Patients and caregivers will NOT be given access to the web-based app and outpatient clinic will provide ostomy care if requested by all patients with ostomies per their regular care.

Who Is Running the Clinical Trial?

Icahn School of Medicine at Mount Sinai

Lead Sponsor

Trials

933

Recruited

579,000+

University of Washington

Collaborator

Trials

1,858

Recruited

2,023,000+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10881728/

Better stoma care using the Stoma App: does it help? A first ... After correction for confounding, the intervention group reported a significant 3.1-point improvement in stoma-related quality of life one month ...

2. withpower.com withpower.com/trial/phase-bladder-cancer-cancer-5-2023-a640a

STOMA Care App for Colorectal Cancer Ostomy Support ... Research shows that using a mobile app for stoma care can improve outcomes for patients after they leave the hospital, and patients are generally satisfied with ...

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10681488/

The effectiveness of multimedia education on self‐care and ... The results indicate that the multimedia education program enhanced home self‐care ability and quality of life among patients with enterostomy.

4. sciencedirect.com sciencedirect.com/science/article/pii/S1462388924001741

Assessing the impact of educational eHealth and mHealth ... This paper quantified the effectiveness of eHealth and mHealth interventions across multiple health outcomes for enterostomy patients.

5. onlinelibrary.wiley.com onlinelibrary.wiley.com/doi/10.1111/jocn.70037

Examining the Impact of Telehealth Stoma Care ... The results of this study demonstrate that telehealth for stoma care is effective in improving stoma adjustment and self-efficacy but has no ...

6. liebertpub.com liebertpub.com/doi/full/10.1089/tmr.2024.0026

The Safety and Effectiveness of Telemedicine for Cancer ... This study aimed to support that the safety and effectiveness of telemedicine in cancer-related colostomy care were not inferior to those of outpatient care.

7. journals.sagepub.com journals.sagepub.com/doi/10.1177/10468781241231050

Supporting stoma patients' self-efficacy with a mobile ... This study aims to gain a better understanding of the problems patients face in ostomy care and to determine how to improve these problems by an ...