Mobile Ostomates Resources for Patients and Caregivers

NCT ID: NCT06157814

Last Updated: 2025-09-25

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 26 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-06-16
• Study Completion Date: 2024-03-07

Brief 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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: SINGLE

Study Groups

STOMA Care

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 Type: EXPERIMENTAL

STOMA Care web-based application

Intervention Type: OTHER

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.

Usual Care

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.

Group Type: ACTIVE_COMPARATOR

Usual Care

Intervention Type: OTHER

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

Interventions

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.

Intervention Type: OTHER

Usual Care

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

Intervention Type: OTHER

Other Intervention Names

STOMA Care

Eligibility Criteria

Inclusion Criteria

• Patients undergoing ostomy surgeries for bladder or colorectal cancer;
• Age 21 or older
• Physically and mentally able to consent and participate
• Access to a phone
• Able to speak/read/write English
• Has an informal/family caregiver (age 21 or greater) willing to participate in the study

Exclusion Criteria

• Patients with metastatic cancer, cancer recurrence, or presence of other cancers
• Not able to speak/read/write English

• Minimum Eligible Age: 21 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Washington

OTHER

Sponsor Role: collaborator

Icahn School of Medicine at Mount Sinai

OTHER

Sponsor Role: lead

Responsible Party

Nihal E Mohamed

Associate Professor of Urology, Director of Patient Education & Behavioral Research

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Nihal Mohamed, PhD

Role: PRINCIPAL_INVESTIGATOR

Icahn School of Medicine at Mount Sinai

Locations

Icahn School of Medicine at Mount Sinai

New York, New York, United States

Countries

United States

Other Identifiers

STUDY-22-00556

Identifier Type: -

Identifier Source: org_study_id