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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 below

Select...

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)

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.

0 / 2Eligibility criteria met

Find a Location

Who is running the clinical trial?

Icahn School of Medicine at Mount SinaiLead Sponsor

862 Previous Clinical Trials

525,536 Total Patients Enrolled

University of WashingtonOTHER

1,741 Previous Clinical Trials

1,847,670 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

Recent research and studies

clinicaltrials.govStudy

Mobile Ostomates Resources for Patients and Caregivers

Nihal E Mohamed 2023. "Mobile Ostomates Resources for Patients and Caregivers". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06157814.