Brief Title: Mobile Ostomates Resources for Patients and Caregivers

INTRODUCTION

• Org Study ID: STUDY-22-00556
• Secondary ID: N/A
• NCT ID: NCT06157814
• Sponsor: Icahn School of Medicine at Mount Sinai

DESCRIPTION

At Mount Sinai Hospital in New York City, we are doing a research study called “Mobile Ostomates REsources” or “MORE” to help people who are considering or have had urostomy surgery because of bladder cancer. We want to better understand the needs of patients and their caregivers to improve a website called STOMA CARE. This website aims to help patients/caregivers learn more about surgery options, how to care for a stoma, and how to feel better physically and emotionally.

You may be eligible to participate in MORE if:
✓ You have been diagnosed with bladder cancer
✓ You are considering, scheduled for, or have had a urostomy surgery
OR
✓ You are a caregiver (spouse, sibling, child, etc.) for someone who has been diagnosed with bladder cancer and is considering, scheduled for, or has had a urostomy surgery

During the study, participants will answer three short online surveys over four weeks. This can be done on your phone/computer from home. 

If you or your caregiver are interested in this study and would like to learn more, you can contact Isabella Johnson at Isabella.Johnson@mountsinai.org or call (207) 314-7164.

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.

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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.

• Overall Status
  Recruiting
• Start Date
  June 16, 2023
• Phase
  Not Applicable
• Study Type
  Interventional