NCT06157814

Mobile Ostomates Resources for Patients and Caregivers

Mobile Ostomates Resources Intervention for Patients and Caregivers

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 26 (actual)
• Sponsor: Icahn School of Medicine at Mount Sinai · Academic / Other
• Sex: All
• Age: 21 Years
• Healthy volunteers: Not accepted

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.

Detailed description

The MORE study was designed guided by the Individual and Family Self-Management Theory to facilitate adaptation to stoma care within three key patient and caregiver unmet need domains: 1) enhancement of knowledge and beliefs (e.g., outcome expectations), 2) enhancement of ostomy-care competencies (e.g., learning skills and building confidence), and 3) enhancement of self-regulation (e.g., stress management). Content for these domains is organized in a web-based app (STOMA Care) 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 modeling competencies. Program software was developed in collaboration with the Information Technology Department at Mount Sinai. A usability testing with 11 patients, caregivers, and nurses showed high acceptability and usability of MORE and led to refinements of the program software. In this proposed pilot study, the research team plan to examine the acceptability and feasibility of the refined MORE in bladder and colorectal cancer patients with new ostomies and their family caregivers. Results from this pilot study will inform a large randomized clinical trial (RCT) of MORE with ostomy patients and their caregivers. Here researchers aim to: Aim 1: Examine the acceptability and feasibility of the refined MORE: The research team will conduct a pilot, randomized, feasibility study with 45 bladder and colorectal cancer patients scheduled for ostomies at Mount Sinai Health System and their family caregivers. The primary outcomes of interest will be measures of feasibility and acceptability of MORE. Feasibility will be evaluated based on the ability to recruit and randomize participants (patient/caregiver dyads) to the two treatment arms (MORE vs. usual care), retain participants for the entire duration of the study period, apply appropriate methods for assessment and implement the program in a diverse, urban ostomy patient population and their family caregivers. Pre- and post-surgical secondary outcomes measured by standardized scales (1 week before surgery; day of discharge, and 4 weeks post-discharge) for the following variables will be used to estimate effect size for powering a larger future RCT: 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). The research team hypothesize that MORE will be acceptable and feasible, will improve patient and caregiver knowledge, stoma-care skills, and quality of life, and will reduce their emotional distress.

Conditions

• Bladder Cancer
• Colorectal Cancer

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2023-06-16
• Primary completion: 2024-03-07
• Completion: 2024-03-07
• First posted: 2023-12-06
• Last updated: 2025-09-25

Locations

1 site across 1 country: United States