Bladder CancerMORENCT06157814
Mobile Ostomates Resources for Patients and Caregivers
A study testing STOMA Care web-based application in people with Bladder Cancer and Colorectal Cancer, run by Icahn School of Medicine at Mount Sinai at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 21 years and older
- Conditions the study is for
- Bladder Cancer, Colorectal Cancer
- What is being tested?
- STOMA Care web-based application
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 26 participants
- Where
- 1 siteUnited States
- Study dates
- 16 Jun 2023to 7 Mar 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Patients with metastatic cancer, cancer recurrence, or presence of other cancers
- Not able to speak/read/write English
Trial locations and contacts
1 site in 1 country.
United States1 site
Icahn School of Medicine at Mount Sinai
New York, New York, 10029
About this study
Official title: Mobile Ostomates Resources Intervention for Patients and Caregivers
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.
Read the 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
- Being tested
- STOMA Care web-based application, Usual Care
- Medical subject headings
- Urinary Bladder Neoplasms, Colorectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
STOMA Care web-based applicationOther
Also called STOMA Care
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 CareOther
Patients and caregivers NOT given access to the web-based application.
| Study group | Role | What they receive |
|---|---|---|
| STOMA Care | Experimental | 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. Receives: Other: STOMA Care web-based application |
| Usual Care | Active comparator | 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. Receives: Other: Usual Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants recruited
Feasibility will be evaluated based on the research team's ability to recruit participants.
Measured: Duration of study (5 weeks)
Number of participants retained for entirety of the study
Feasibility will be evaluated based on the research team's ability to recruit participants 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.
Measured: Duration of study (5 weeks)
Secondary outcomes (11)
Stoma/Ostomy Knowledge Questionnaire
This questionnaire assesses respondents' knowledge of standard ostomy care procedures (reaction to stoma, removing the stoma appliance, measuring the stoma diameter, adjusting the size of the stoma diameter in a new stoma appliance, skin care, fitting a new stoma appliance, and emptying procedure). Minimum score = 0, Maximum score = 21. A higher score indicates higher skill in ostomy care with less dependence on an ostomy nurse.
Measured: Duration of study (5 weeks)
Illness Perception Questionnaire (IPQ)
This questionnaire assesses five cognitive illnesses. Responses to the items can be grouped into categories such as stress, lifestyle, etc. to measure respondents' perception of illness. Subscale scores range from 1-10. Minimum score= 0, Maximum score= 80; higher scores indicate worse illness perception.
Eight items in addition to a causal scale graded on a five-point Likert scale.
Measured: Duration of study (5 weeks)
The General Self-Efficacy Scale
This scale assesses a general sense of perceived self-efficacy, predicting respondents' ability to cope with daily hassles and adaptation after stressful life events. Minimum score = 10, Maximum score = 40; higher scores indicate higher self-efficacy.
Measured: Duration of study (5 weeks)
Adapted Quality of Life Questionnaire for Patients with an Ostomy
Questions adopted from the Quality-of-Life Scale, respondents will elaborate on their difficulties in stoma care, surgery and treatment-related goals, then indicate whether they have achieved their goals and how satisfied they are with their achievement. For each item, 0 = worst outcome/negative QOL and 10 = best outcome/positive QOL. A total QOL score is obtained by adding the scores on all 10-point items and dividing by the total number of items (43). Minimum score = 0, Maximum score = 10. Higher scores indicate a general better quality of life among ostomates.
Measured: Duration of study (5 weeks)
Number of nurse home visits
Measured: Duration of study (5 weeks)
Number of visits to emergency room
Measured: Duration of study (5 weeks)
Brief Symptoms Inventory (BSI-18) Score
Brief Symptoms Inventory (BSI-18) will measure respondents' distress symptoms. The assessment contains three six-item scales for measuring somatization, depression, anxiety, and the Global Severity Index (GSI). Respondents rate items on a scale from "Not at all," indicating low psychological distress, to "Extremely," indicating high psychological distress in that area. Thus, higher responses of "Extremely" across the scales signify greater distress in that area being measured. Subscale scores range from 1-5. Minimum score = 0, Maximum score = 90; higher scores indicate more distress.
Measured: Duration of study (5 weeks)
Quality of Life Questionnaire for Patients with an Ostomy
This 43-item scale assesses the psychological, social, and spiritual wellbeing of respondents, graded on a 0-10 scale in which 0 reflects very poor quality in that area and 10 is the best. Total quality of life (QOL) is calculated by adding the scores on all of the 10-point items. Minimum score = 0, maximum = 430. Higher scores indicate a better quality of life.
Measured: Duration of study (5 weeks)
Unmet Needs
This measure assesses respondents' needs including psychological, physical, informational, daily living, patient care, and sexuality needs. Respondents may choose one of five possible responses to all 33 questions ranging from "No need" to High need". Minimum score = 1, Maximum score = 165. Higher need answers indicate greater unmet needs.
Measured: Duration of study (5 weeks)
Satisfaction with Care/Communication
This measure assesses satisfaction with care and communication between cancer in patients with hospital-based care and their care team, caretakers, and significant others. Respondent's report how much each of 11 statements apply to them within the past month using the five responses ranging from "Not much" to "Very much". Minimum score = 1, Maximum score = 55. Higher responses of "very much" indicate low satisfaction.
Measured: Duration of study (5 weeks)
Symptom Measures
Symptoms of pain, fatigue, anxiety, and depression will be reported as a composite score, measured using five questions with scales ranging from 0 (none) to 10 (the worst imaginable) as well as the impact that these symptoms have on respondents' quality of life measured using three questions with scales ranging from 1(none) to 5 (very great impact. Full composite score from 5 to 40 A higher score indicates more adverse physical and psychological symptoms experienced and poorer quality of life as a result of the symptoms.
Measured: Duration of study (5 weeks)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Dec 2023
- Study start16 Jun 2023
- Primary completion7 Mar 2024
- Study completion7 Mar 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bladder CancerStudies of the same condition, open and under way.
- More trials run by Icahn School of Medicine at Mount SinaiThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 26 participants (actual)
Sponsor and investigators
- Lead sponsor
- Icahn School of Medicine at Mount Sinai
- Sponsor type
- University, hospital or other
- Collaborators
- University of Washington
- Responsible party
- Principal investigator, Nihal E Mohamed, Icahn School of Medicine at Mount Sinai
- Investigators
- Nihal Mohamed, PhD, Principal investigator, Icahn School of Medicine at Mount Sinai
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06157814
- Sponsor's protocol ID
- STUDY-22-00556
- Acronym
- MORE
- Status last verified
- Jul 2025
- First submitted
- 8 Aug 2023
- Last updated
- 25 Sep 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: In addition to being used to complete this research study, personal information (such as, name, address, date of birth, social security number), study data, may also be used and shared for additional (future) research. Before anything is shared, identifying personal information will be removed and it will be replaced with a code. Researchers are not planning on giving you the details of any of this future research nor the results. If patients do not want any future research to be done with your data and/or samples, even with identity removed, they will not be included in this study.
Study at a glance
From the registry record, last updated by the sponsor on 25 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Mobile Ostomates Resources Intervention for Patients and Caregivers
- ClinicalTrials.gov ID
- NCT06157814
- Acronym / sponsor ID
- MORE / STUDY-22-00556
- Conditions
- Bladder Cancer, Colorectal Cancer
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 26 participants (actual)
- Lead sponsor
- Icahn School of Medicine at Mount SinaiUniversity, hospital or other
- Collaborators
- University of Washington
- Study start
- 16 Jun 2023 (actual)
- Primary completion
- 7 Mar 2024 (actual)
- Study completion
- 7 Mar 2024 (actual)
- First posted
- 6 Dec 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| STOMA Care | Experimental | Other: STOMA Care web-based applicationPatients 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. |
| Usual Care | Active comparator | Other: Usual CarePatients 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. |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (2 listed)
- Patients with metastatic cancer, cancer recurrence, or presence of other cancers
- Not able to speak/read/write English
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| STOMA Care web-based applicationAlso: STOMA CareThe 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 | STOMA Care |
| Usual CarePatients and caregivers NOT given access to the web-based application. | Other | Usual Care |
Primary outcome
Number of participants recruited
Time frame: Duration of study (5 weeks)
Feasibility will be evaluated based on the research team's ability to recruit participants.
Number of participants retained for entirety of the study
Time frame: Duration of study (5 weeks)
Feasibility will be evaluated based on the research team's ability to recruit participants 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.
11 secondary outcomes
Stoma/Ostomy Knowledge Questionnaire
Time frame: Duration of study (5 weeks)
Illness Perception Questionnaire (IPQ)
Time frame: Duration of study (5 weeks)
The General Self-Efficacy Scale
Time frame: Duration of study (5 weeks)
Adapted Quality of Life Questionnaire for Patients with an Ostomy
Time frame: Duration of study (5 weeks)
Number of nurse home visits
Time frame: Duration of study (5 weeks)
Number of visits to emergency room
Time frame: Duration of study (5 weeks)
Brief Symptoms Inventory (BSI-18) Score
Time frame: Duration of study (5 weeks)
Quality of Life Questionnaire for Patients with an Ostomy
Time frame: Duration of study (5 weeks)
Unmet Needs
Time frame: Duration of study (5 weeks)
Satisfaction with Care/Communication
Time frame: Duration of study (5 weeks)
Symptom Measures
Time frame: Duration of study (5 weeks)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Sep 2025.
- Individual participant dataSharing planned: Yes. In addition to being used to complete this research study, personal information (such as, name, address, date of birth, social security number), study data, may also be used and shared for additional (future) research. Before anything is shared, identifying personal information will be removed and it will be replaced with a code. Researchers are not planning on giving you the details of any of this future research nor the results. If patients do not want any future research to be done with your data and/or samples, even with identity removed, they will not be included in this study.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Nihal Mohamed, PhD principal investigator
Icahn School of Medicine at Mount Sinai
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing STOMA Care web-based application in people with Bladder Cancer and Colorectal Cancer, run by Icahn School of Medicine at Mount Sinai at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of participants recruited (time frame: Duration of study (5 weeks)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Sep 2025.