ClinicalTrials.gg
Not yet recruitingNCT07912034Updated Nov 3, 2026

EHR Integrated Remote Patient Monitoring to Reduce Readmission for Patients With Bladder Cancer Undergoing Cystectomy

An interventional study of Best Practice and Communication Intervention in Bladder Carcinoma, sponsored by University of Michigan Rogel Cancer Center. Not yet recruiting at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-11-03.

Sponsored by University of Michigan Rogel Cancer Center · Not applicable, Interventional, and Health services research

Updated Nov 3, 2026Newly registeredGo to Updates ↓
Phase
Not applicable
Study type
Interventional
Enrollment
50
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study 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. 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.

02

Conditions studied

  • Bladder Carcinoma
03

In context

Urinary Bladder Neoplasms

1,798 studies on the registry are indexed under Urinary Bladder Neoplasms; 445 are open to participants now.

This study's planned enrollment of 50 is below the median of 60 across 1,296 interventional studies indexed under Urinary Bladder Neoplasms.

Browse Urinary Bladder Neoplasms studies →

Lead sponsor

University of Michigan Rogel Cancer Center is the lead sponsor of 323 studies on the registry; 47 are open to participants now.

Of its 46 completed or terminated interventional studies of FDA-regulated products, 31 (67%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Eligibility criteria

Inclusion Criteria:

  • 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
05

Study design

Phase
Not applicable
Primary purpose
Health services research
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
50 participants (estimated)

Study arms

  • Experimental
    Arm I (EHR integrated remote monitoring app)

    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.

    Other: Communication Intervention · Other: Interview · Behavioral: Smartphone Application-based Intervention · Other: Supportive Care · Other: Survey Administration

  • Experimental
    Arm II (Standard care)

    Patients receive access to the MyUofMHealth App and undergo standard post-operative care.

    Other: Best Practice · Other: Interview · Behavioral: Smartphone Application-based Intervention · Other: Survey Administration

Interventions

  • OtherBest Practice

    Undergo standard post-operative care

    Also known as: standard of care, standard therapy

  • OtherCommunication Intervention

    Communicate with care team

  • OtherInterview

    Ancillary studies

  • BehavioralSmartphone Application-based Intervention

    Receive access to the MyUofMHealth App

    Also known as: Smartphone App-based Intervention, Smartphone Intervention, Smartphone-based Intervention

  • BehavioralSmartphone Application-based Intervention

    Receive notifications

    Also known as: Smartphone App-based Intervention, Smartphone Intervention, Smartphone-based Intervention

  • OtherSupportive Care

    Complete assessments

    Also known as: Supportive Therapy, Symptom Management, Therapy, Supportive

  • OtherSurvey Administration

    Ancillary studies

06

What researchers measure

Primary outcomes

  1. Trial randomization meeting goal of 50 patients (feasibility)

    Will be reported as number of participants accrued and randomized.

    Time frame: Up to 6 months

Secondary outcomes

  1. Intervention deployment in > 90% of patients randomized to intervention arm (feasibility)

    Will be reported as proportions with the associated 95% binomial confidence intervals.

    Time frame: Up to 6 months

  2. Trial enrollment of ≥ 50% of eligible patients (acceptability)

    Will be reported as proportions with the associated 95% binomial confidence intervals.

    Time frame: Up to 6 months

  3. 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.

    Time frame: Up to 90 days from discharge

07

Study locations

1 site
08

References and documents

Individual participant data

Plan to share: 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.

Supporting information: Study protocol, Clinical study report, Analytic code

Time frame: for up to 10 years

Access criteria: For interested researchers

No publications or documents are linked to this record.

09

Timeline

1 registry update since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Start is estimated for Dec 2026; primary completion for Jun 2028, 18 months later.

Of 235 non-industry interventional studies with no phase under Urinary Bladder Neoplasms, half reached primary completion within 40 months of starting (the median), counting those still running; a quarter within 21 and three quarters within 70. This study's planned 18 months is below that.

Counting every sponsor, half of 244 studies reached it within 39 months; a quarter within 20 and three quarters within 69.

How these figures are worked out, and which studies are left out of them.

Registered
Oct 27, 2026
First posted
Nov 3, 2026
StartEst.
Dec 1, 2026
Primary completionEst.
Jun 1, 2028
CompletionEst.
Jun 1, 2028
Last update
Nov 3, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
Registered
First appeared on the registry. No changes since
Nov 3, 2026
Show all 1 update
  1. Nov 3, 2026
    First appeared on the registry

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

10

Registry details

Key details

Study ID
NCT07912034
Responsible party
Sponsor
First posted
Nov 3, 2026
Start date
Dec 1, 2026 (estimated)
Primary completion
Jun 1, 2028 (estimated)
Completion
Jun 1, 2028 (estimated)
Last update
Nov 3, 2026

Study contacts

Tudor Borza
principal investigator · University of Michigan Rogel Cancer Center

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Oct 2026. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion