Clinical trial NCT06157814: Mobile Ostomates Resources for Patients and Caregivers
Official title: Mobile Ostomates Resources Intervention for Patients and Caregivers
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Bladder Cancer
Colorectal Cancer
Lead sponsor: Icahn School of Medicine at Mount Sinai
Sponsor class: OTHER
Collaborators: name: University of Washington
First posted: 2023-12-06
Enrollment: 90
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: All patients recruited, aside from their caregivers, will have already received OR are scheduled for ostomy surgery. Patient and caregivers will be randomized 1:1 to the control and intervention group. The intervention group of patents and caregivers will be given access to the STOMA Care app while the control group of patents and caregivers will NOT be given access to the STOMA Care app during the course of the study.
Primary purpose: OTHER

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.

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

Primary outcomes:
measure: Number of participants recruited
timeFrame: Duration of study (5 weeks)
measure: Number of participants retained for entirety of the study
timeFrame: Duration of study (5 weeks)
Secondary outcomes:
measure: Stoma/Ostomy Knowledge Questionnaire
timeFrame: Duration of study (5 weeks)
measure: Illness Perception Questionnaire (IPQ)
timeFrame: Duration of study (5 weeks)
measure: The General Self-Efficacy Scale
timeFrame: Duration of study (5 weeks)
measure: Adapted Quality of Life Questionnaire for Patients with an Ostomy
timeFrame: Duration of study (5 weeks)
measure: Number of nurse home visits
timeFrame: Duration of study (5 weeks)
measure: Number of visits to emergency room
timeFrame: Duration of study (5 weeks)
measure: Brief Symptoms Inventory (BSI-18) Score
timeFrame: Duration of study (5 weeks)
measure: Quality of Life Questionnaire for Patients with an Ostomy
timeFrame: Duration of study (5 weeks)
measure: Unmet Needs
timeFrame: Duration of study (5 weeks)
measure: Satisfaction with Care/Communication
timeFrame: Duration of study (5 weeks)
measure: Symptom Measures
timeFrame: Duration of study (5 weeks)
Other outcomes:
Locations:
city: New York
country: United States
facility: Icahn School of Medicine at Mount Sinai
state: New York
Study officials:
affiliation: Icahn School of Medicine at Mount Sinai
name: Nihal Mohamed, PhD
role: PRINCIPAL_INVESTIGATOR
References: