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

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
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 below
I am having surgery for an ostomy due to bladder or colorectal cancer.
I am 21 years old or older.
I am mentally and physically capable of giving consent and participating.
I have a caregiver aged 21 or older willing to be part of the study.

MORE Trial Timeline

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

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.

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Who is running the clinical trial?

Icahn School of Medicine at Mount SinaiLead Sponsor
858 Previous Clinical Trials
524,201 Total Patients Enrolled
University of WashingtonOTHER
1,737 Previous Clinical Trials
1,843,371 Total Patients Enrolled
Nihal Mohamed, PhDPrincipal InvestigatorIcahn School of Medicine at Mount Sinai
1 Previous Clinical Trials
21 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there any vacancies remaining for participants in this clinical experiment?

"According to the data present on clinicaltrials.gov, this medical trial is currently in the process of recruiting participants. The study was initially posted online on June 16th 2023 and its most recent update occurred on November 27th 2023."

Answered by AI

How many participants have signed up to take part in this clinical investigation?

"Affirmative, the trial is still recruiting candidates according to clinicaltrials.gov records. This research was made public on June 16th 2023 and its most recent update occured on November 27th of the same year. 90 participants need to be enrolled in 1 medical centre for this study's completion."

Answered by AI
~16 spots leftby Jun 2024