Bladder CarcinomaNCT07912034
EHR Integrated Remote Patient Monitoring to Reduce Readmission for Patients With Bladder Cancer Undergoing Cystectomy
A study testing Best Practice, Communication Intervention and Interview in people with Bladder Carcinoma, run by University of Michigan Rogel Cancer Center at 1 site in United States.
Trial summary
This clinical trial tests the feasibility of an electronic health record (EHR) integrated remote patient monitoring intervention to reduce readmission for patients with bladder cancer undergoing cystectomy. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Bladder Carcinoma
- What is being tested?
- Best Practice, Communication Intervention and Interview
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Dec 2026to 1 Jun 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adults age 18 and older
- English speaking
- Patient currently inpatient at the University of Michigan (Michigan Medicine) who has undergone a radical cystectomy with reconstruction for bladder cancer
- Personal access or access via a caregiver to a compatible device where notifications from the Michigan Medicine MyUofMHealth account can be enabled
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site
University of Michigan Rogel Cancer Center
Ann Arbor, Michigan, 48109
Tudor Borza, 734-936-7030, tborza@med.umich.edu
Tudor Borza
About this study
Official title: CLEAR Cystectomy: A Pilot Randomized Trial Assessing Remote Patient Monitoring in Bladder Cancer Patients
This clinical trial tests the feasibility of an electronic health record (EHR) integrated remote patient monitoring intervention to reduce readmission for patients with bladder cancer undergoing cystectomy. Cystectomy is the preferred treatment for locally advanced bladder cancer and involves removal of the bladder, prostate or uterus and part of vagina, and pelvic lymph nodes along with reconstruction of the urinary tract using a segment of bowel. Hospital readmission rates following cystectomy exceed 25% and are among the highest of any surgery. A significant barrier to identifying complications early arises from our inability to monitor patients once they are discharged from the hospital. The EHR integrated remove patient monitoring intervention helps with monitoring of symptoms after a patient's discharge from a cystectomy procedure and provides a direct line of communication between patients and their care team when concerning symptoms arise. This may reduce readmission rate for patients with bladder cancer undergoing cystectomy.
- Conditions
- Bladder Carcinoma
- Being tested
- Best Practice, Communication Intervention, Interview, Smartphone Application-based Intervention, Supportive Care
- Medical subject headings
- Urinary Bladder Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Best PracticeOther
Also called standard of care, standard therapy
Undergo standard post-operative care
Communication InterventionOther
Communicate with care team
InterviewOther
Ancillary studies
Smartphone Application-based InterventionBehavioural
Also called Smartphone App-based Intervention, Smartphone Intervention, Smartphone-based Intervention
Receive access to the MyUofMHealth App
Smartphone Application-based InterventionBehavioural
Also called Smartphone App-based Intervention, Smartphone Intervention, Smartphone-based Intervention
Receive notifications
Supportive CareOther
Also called Supportive Therapy, Symptom Management, Therapy, Supportive
Complete assessments
Survey AdministrationOther
Ancillary studies
| Study group | Role | What they receive |
|---|---|---|
| Arm I (EHR integrated remote monitoring app) | Experimental | Patients receive access to the MyUofMHealth App and, starting at discharge, receive notifications, up to 3 times per day with frequency decreasing to daily, then less frequently over time, prompting them to complete medication and pain assessments, record food and fluid intake and exercise and triage/symptom tracking, and provide a direct line of communication to their care team if concerning symptoms arise, up to day 35 post discharge. Receives: Other: Communication Intervention; Other: Interview; Behavioral: Smartphone Application-based Intervention; Other: Supportive Care; Other: Survey Administration |
| Arm II (Standard care) | Experimental | Patients receive access to the MyUofMHealth App and undergo standard post-operative care. Receives: Other: Best Practice; Other: Interview; Behavioral: Smartphone Application-based Intervention; Other: Survey Administration |
What is being measured
The primary outcome is the main question the study is designed to answer.
Trial randomization meeting goal of 50 patients (feasibility)
Will be reported as number of participants accrued and randomized.
Measured: Up to 6 months
Secondary outcomes (3)
Intervention deployment in > 90% of patients randomized to intervention arm (feasibility)
Will be reported as proportions with the associated 95% binomial confidence intervals.
Measured: Up to 6 months
Trial enrollment of ≥ 50% of eligible patients (acceptability)
Will be reported as proportions with the associated 95% binomial confidence intervals.
Measured: Up to 6 months
Hospital free days
A hospital day will be a day that includes an emergency department visit or acute care hospital or hospitalization within 90 days from discharge. A hospital-free day will be any day that is not a hospital day and when a patient is alive. Will be reported by arm using a median or mean, and effect sizes will be calculated and their associated confidence intervals.
Measured: Up to 90 days from discharge
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Nov 2026
- Study start1 Dec 2026 (estimated)
- Primary completion1 Jun 2028 (estimated)
- Study completion1 Jun 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bladder CarcinomaStudies of the same condition, open and under way.
- More trials run by University of Michigan Rogel Cancer CenterThe 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
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomization will be performed in a 1:1 fashion using the REDCap randomization module with permuted blocks of variable size (2 and 4)
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Michigan Rogel Cancer Center
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Tudor Borza, Principal investigator, University of Michigan Rogel Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07912034
- Sponsor's protocol ID
- UMCC 2026.050
- Other IDs
- NCI-2026-07233, UMCC 2026.050, R34CA297281
- Status last verified
- Oct 2026
- First submitted
- 27 Oct 2026
- Last updated
- 3 Nov 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: we will share a de-identified version of the quantitative data, including the data output from the application (e.g., frequency of patient engagement, patient symptoms, pain medications, etc.) and the responses to both the PROMIS and satisfaction questionnaires.
Study at a glance
From the registry record, last updated by the sponsor on 3 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- CLEAR Cystectomy: A Pilot Randomized Trial Assessing Remote Patient Monitoring in Bladder Cancer Patients
- ClinicalTrials.gov ID
- NCT07912034
- Acronym / sponsor ID
- UMCC 2026.050
- Conditions
- Bladder Carcinoma
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- University of Michigan Rogel Cancer CenterUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- 1 Dec 2026 (estimated)
- Primary completion
- 1 Jun 2028 (estimated)
- Study completion
- 1 Jun 2028 (estimated)
- First posted
- 3 Nov 2026 (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.
This clinical trial tests the feasibility of an electronic health record (EHR) integrated remote patient monitoring intervention to reduce readmission for patients with bladder cancer undergoing cystectomy. Cystectomy is the preferred treatment for locally advanced bladder cancer and involves removal of the bladder, prostate or uterus and part of vagina, and pelvic lymph nodes along with reconstruction of the urinary tract using a segment of bowel. Hospital readmission rates following cystectomy exceed 25% and are among the highest of any surgery. A significant barrier to identifying complications early arises from our inability to monitor patients once they are discharged from the hospital. The EHR integrated remove patient monitoring intervention helps with monitoring of symptoms after a patient's discharge from a cystectomy procedure and provides a direct line of communication between patients and their care team when concerning symptoms arise. This may reduce readmission rate for patients with bladder cancer undergoing cystectomy.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Randomization will be performed in a 1:1 fashion using the REDCap randomization module with permuted blocks of variable size (2 and 4)
| Arm | Type | Receives |
|---|---|---|
| Arm I (EHR integrated remote monitoring app) | Experimental | Other: Communication Intervention, Other: Interview, Behavioral: Smartphone Application-based Intervention, Other: Supportive Care, Other: Survey AdministrationPatients receive access to the MyUofMHealth App and, starting at discharge, receive notifications, up to 3 times per day with frequency decreasing to daily, then less frequently over time, prompting them to complete medication and pain assessments, record food and fluid intake and exercise and triage/symptom tracking, and provide a direct line of communication to their care team if concerning symptoms arise, up to day 35 post discharge. |
| Arm II (Standard care) | Experimental | Other: Best Practice, Other: Interview, Behavioral: Smartphone Application-based Intervention, Other: Survey AdministrationPatients receive access to the MyUofMHealth App and undergo standard post-operative care. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Adults age 18 and older
- English speaking
- Patient currently inpatient at the University of Michigan (Michigan Medicine) who has undergone a radical cystectomy with reconstruction for bladder cancer
- Personal access or access via a caregiver to a compatible device where notifications from the Michigan Medicine MyUofMHealth account can be enabled
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| Best PracticeAlso: standard of care, standard therapyUndergo standard post-operative care | Other | Arm II (Standard care) |
| Communication InterventionCommunicate with care team | Other | Arm I (EHR integrated remote monitoring app) |
| InterviewAncillary studies | Other | Arm I (EHR integrated remote monitoring app), Arm II (Standard care) |
| Smartphone Application-based InterventionAlso: Smartphone App-based Intervention, Smartphone Intervention, Smartphone-based InterventionReceive access to the MyUofMHealth App | Behavioural | Arm I (EHR integrated remote monitoring app), Arm II (Standard care) |
| Smartphone Application-based InterventionAlso: Smartphone App-based Intervention, Smartphone Intervention, Smartphone-based InterventionReceive notifications | Behavioural | Arm I (EHR integrated remote monitoring app) |
| Supportive CareAlso: Supportive Therapy, Symptom Management, Therapy, SupportiveComplete assessments | Other | Arm I (EHR integrated remote monitoring app) |
| Survey AdministrationAncillary studies | Other | Arm I (EHR integrated remote monitoring app), Arm II (Standard care) |
Primary outcome
Trial randomization meeting goal of 50 patients (feasibility)
Time frame: Up to 6 months
Will be reported as number of participants accrued and randomized.
3 secondary outcomes
Intervention deployment in > 90% of patients randomized to intervention arm (feasibility)
Time frame: Up to 6 months
Trial enrollment of ≥ 50% of eligible patients (acceptability)
Time frame: Up to 6 months
Hospital free days
Time frame: Up to 90 days from discharge
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Nov 2026.
- Individual participant dataSharing planned: Yes. we will share a de-identified version of the quantitative data, including the data output from the application (e.g., frequency of patient engagement, patient symptoms, pain medications, etc.) and the responses to both the PROMIS and satisfaction questionnaires.
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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.
Tudor Borza principal investigator
University of Michigan Rogel Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Best Practice, Communication Intervention and Interview in people with Bladder Carcinoma, run by University of Michigan Rogel Cancer Center 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 4 inclusion and 0 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: opening soon, as of the sponsor's last update on 3 Nov 2026. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Trial randomization meeting goal of 50 patients (feasibility) (time frame: Up to 6 months). 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 3 Nov 2026.