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Mobile Ostomates Resources for Patients and Caregivers

NCT06157814 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 26

Last updated 2025-09-25

No results posted yet for this study

Summary

The scope of this research is to examine the acceptability and feasibility of a refined web-based intervention ("STOMA Care" app) by conducting a randomized pilot consisting of bladder and colorectal cancer patients scheduled for ostomy surgery at Mount Sinai Health System and their primary caregivers. This study aims to explore the impact of the app on stoma-related knowledge and beliefs, patient stoma-care skills and self-efficacy beliefs, and self-regulation and adaptation (e.g., distress and quality of life) among patients and their informal caregivers.

Conditions

Interventions

OTHER

STOMA Care web-based application

The STOMA Care App, with program software developed in collaboration with the Information Technology Department at Mount Sinai, is organized in a web-based app accessible on any smart-phone (e.g., Android and iOS), tablet, or computer device and consist of: 1) provision of information through text, and graphics; 2) videos of physicians and nurses answering questions; and 3) videos of patients describing their experiences and modelling competencies 4) mental health, support group, and ostomy supplier resources.

OTHER

Usual Care

Patients and caregivers NOT given access to the web-based application.

Sponsors & Collaborators

Principal Investigators

  • Nihal Mohamed, PhD · Icahn School of Medicine at Mount Sinai

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
21 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-06-16
Primary Completion
2024-03-07
Completion
2024-03-07

Countries

  • United States

Study Locations

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Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06157814 on ClinicalTrials.gov