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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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up duration of study (5 weeks)
Awards & highlights
MORE Trial 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.
MORE Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am having surgery for an ostomy due to bladder or colorectal cancer.
Select...
I am 21 years old or older.
MORE Trial 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)
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 moreMORE 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.
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Who is running the clinical trial?
Icahn School of Medicine at Mount SinaiLead Sponsor
871 Previous Clinical Trials
527,161 Total Patients Enrolled
University of WashingtonOTHER
1,749 Previous Clinical Trials
1,838,554 Total Patients Enrolled
Nihal Mohamed, PhDPrincipal InvestigatorIcahn School of Medicine at Mount Sinai
2 Previous Clinical Trials
231 Total Patients Enrolled
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