What is the mechanism of action of this treatment?

Bladder cancer treatments primarily include surgery, chemotherapy, and radiation therapy. Surgery, such as cystectomy, involves the removal of the bladder to eliminate cancerous tissues. Chemotherapy uses drugs to kill cancer cells or stop them from growing, often administered before or after surgery to reduce recurrence. Radiation therapy uses high-energy rays to target and destroy cancer cells. These treatments are crucial for bladder cancer patients as they directly address the cancer, but they can also lead to significant physical and psychological challenges. Educational and supportive resources, like the STOMA Care app, are essential as they help patients manage stoma care, improve self-efficacy, and adapt to life changes, ultimately enhancing their quality of life and treatment outcomes.

What side effects are associated with this type of intervention?

Common treatments for bladder cancer, such as cystectomy and urinary diversion, can lead to significant side effects including infections, bowel obstruction, and issues related to the stoma such as skin irritation and leakage. Chemotherapy, often used in conjunction with surgery, can cause nausea, vomiting, hair loss, and increased risk of infections due to lowered blood cell counts. Radiation therapy may result in gastrointestinal symptoms like diarrhea and urinary symptoms such as frequency and urgency. These treatments can also have profound psychological impacts, necessitating supportive care to manage emotional and mental health.

What prior FDA approvals exist?

FDA-approved treatments for bladder cancer include a range of chemotherapies, immunotherapies, and targeted therapies. Notable drugs include cisplatin-based chemotherapy regimens, which are often used in neoadjuvant and adjuvant settings. Immunotherapies such as Atezolizumab and Pembrolizumab have been approved for advanced or metastatic urothelial carcinoma. Enfortumab Vedotin, an antibody-drug conjugate, has also been approved for patients who have previously received platinum-containing chemotherapy and a PD-1 or PD-L1 inhibitor. These treatments are relevant to patients undergoing radical cystectomy, which may necessitate stoma care, aligning with the focus of the STOMA Care app on improving stoma-related outcomes.

What other types of research exist?

Promising alternatives to the STOMA Care app for bladder cancer patients include: 1) Mobile health applications that provide real-time monitoring and notifications for stoma care, such as those integrating AI for personalized care recommendations. 2) Digital platforms offering virtual support groups and telehealth consultations with stoma care specialists. 3) Comprehensive patient decision aids that facilitate shared decision-making and provide detailed information on stoma management options. 4) Enhanced digital communication tools that allow for early detection of postoperative complications and continuous patient support.

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STOMA Care App for Colorectal Cancer Ostomy Support (MORE Trial)

N/A

Recruiting

Led By Nihal Mohamed, PhD

Research Sponsored by Icahn School of Medicine at Mount Sinai

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Patients undergoing ostomy surgeries for bladder or colorectal cancer

Age 21 or older

Must not have

Patients with metastatic cancer, cancer recurrence, or presence of other cancers

Not able to speak/read/write English

Timeline

Screening 3 weeks

Treatment Varies

Follow Up duration of study (5 weeks)

Awards & highlights

Summary

This trial explores the impact of an app on stoma-related knowledge and skills, self-efficacy beliefs, and self-regulation among cancer patients and their caregivers before and after ostomy surgery.

Who is the study for?

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.Check my eligibility

What is being tested?

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.See study design

What are the potential side effects?

Since this trial involves a web-based application rather than medication, traditional side effects are not applicable. However, users may experience discomfort if they find the technology challenging or if it fails to meet their expectations.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

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

Select...

I am 21 years old or older.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

Select...

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

Select...

I cannot speak, read, or write in English.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ duration of study (5 weeks)

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~duration of study (5 weeks)

This trial's timeline: 3 weeks for screening, Varies for treatment, and duration of study (5 weeks) for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Number of participants recruited

Number of participants retained for entirety of the study

Secondary outcome measures

Adapted Quality of Life Questionnaire for Patients with an Ostomy

Brief Symptoms Inventory (BSI-18) Score

Illness Perception Questionnaire (IPQ)

+8 more

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: STOMA CareExperimental Treatment1 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 CareActive Control1 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.

0 / 4Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Bladder cancer treatments primarily include surgery, chemotherapy, and radiation therapy. Surgery, such as cystectomy, involves the removal of the bladder to eliminate cancerous tissues. Chemotherapy uses drugs to kill cancer cells or stop them from growing, often administered before or after surgery to reduce recurrence. Radiation therapy uses high-energy rays to target and destroy cancer cells. These treatments are crucial for bladder cancer patients as they directly address the cancer, but they can also lead to significant physical and psychological challenges. Educational and supportive resources, like the STOMA Care app, are essential as they help patients manage stoma care, improve self-efficacy, and adapt to life changes, ultimately enhancing their quality of life and treatment outcomes.

Chemoradiation for organ preservation in the treatment of muscle-invasive bladder cancer.

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Who is running the clinical trial?

Icahn School of Medicine at Mount SinaiLead Sponsor

871 Previous Clinical Trials

527,182 Total Patients Enrolled

University of WashingtonOTHER

1,762 Previous Clinical Trials

1,876,392 Total Patients Enrolled

Nihal Mohamed, PhDPrincipal InvestigatorIcahn School of Medicine at Mount Sinai

2 Previous Clinical Trials

231 Total Patients Enrolled

~43 spots leftby Jul 2025

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