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

90 Participants Needed

Trial Summary

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 data supports the effectiveness of the STOMA Care treatment 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 such apps, which help them manage their care better. ^{1 2 3 4 5}

How is the STOMA Care App treatment different from other treatments for colorectal cancer ostomy support?

The STOMA Care App is unique because it uses a mobile application to help patients manage their stoma care at home, which can improve their self-efficacy (confidence in managing their own care) and potentially enhance their quality of life. Unlike traditional treatments that rely on in-person education and support, this app provides continuous, accessible support and education, helping patients adjust to life with a stoma more effectively. ^{1 2 4 5 6}

What is the purpose of this trial?

This trial tests the 'STOMA Care' app, which helps bladder and colorectal cancer patients and their caregivers learn stoma care. It targets those who need extra support. The app offers educational content, expert advice, and peer experiences to improve knowledge, skills, and emotional well-being.

Research Team

Nihal Mohamed, PhD

Principal Investigator

Icahn School of Medicine at Mount Sinai

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

References

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

Effects of a home care mobile app on the outcomes of discharged patients with a stoma: A randomised controlled trial. [2018]

2. England pubmed.ncbi.nlm.nih.gov

Patient satisfaction with stoma care and their expectations on mobile apps for supportive care. [2023]

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

Systematic Review of Ostomy Care Pathways. [2023]

4. Ireland pubmed.ncbi.nlm.nih.gov

Patient education interventions for colorectal cancer patients with stoma: A systematic review. [2018]

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

What do surgical oncology staff nurses know about colorectal cancer ostomy care? [2016]

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

The Quality of Life of Patients with Colorectal Cancer and a Stoma in China: A Quantitative Cross-sectional Study. [2021]