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CompletedNCT03801954Updated May 15, 2023

Implementation of Nutrition Education Videos for Patients Undergoing Radical Cystectomy

An observational study in Bladder Cancer, sponsored by University of Kansas Medical Center. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2023-05-15.

Sponsored by University of Kansas Medical Center · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
15
Ages
18 Years and older
Sex
All
01

Study summary

By doing this study the investigators hope to learn if educational videos focusing on nutrition for bladder cancer patients are a good and effective way to help people improve their nutrition and recovery after radical cystectomy (RC).

Read the detailed description

Bladder Cancer is the fifth most common cancer in the USA. The primary treatment for invasive bladder cancer is chemotherapy followed by RC. Patients undergoing this surgery are at risk for complications. Being malnourished can increase the risk of mortality by three times. The patients also suffer from taste alterations after chemotherapy and gastrointestinal disturbances such as diarrhea and constipation. These can lead to poor nutritional intake and malabsorption of nutrients.

This study is being done to develop an educational video series for patients undergoing RC and assess their impact. The videos are created to address the nutritional needs of these patients and improve their outcomes after surgery.

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Conditions studied

  • Bladder Cancer

Keywords

  • Nutrition
  • Diet
  • Radical cystectomy
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In context

Urinary Bladder Neoplasms

1,649 studies on the registry are indexed under Urinary Bladder Neoplasms; 427 are open to participants now.

This study's enrollment of 15 is below the median of 179 across 385 observational studies indexed under Urinary Bladder Neoplasms.

Browse Urinary Bladder Neoplasms studies →

Lead sponsor

University of Kansas Medical Center is the lead sponsor of 492 studies on the registry; 113 are open to participants now.

Of its 38 completed or terminated interventional studies of FDA-regulated products, 24 (63%) have results posted.

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

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Patients who present to the University of Kansas Urology clinic for bladder cancer will be screened for participation in the study.

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Diagnosed with bladder cancer and scheduled to undergo a radical cystectomy or has undergone a radical cystectomy OR be the caregiver of a patient diagnosed with bladder cancer who is scheduled to undergo a radical cystectomy or has undergone a radical cystectomy

Exclusion criteria

Exclusion Criteria:

  • 1. Patients who are under 18 years old are not allowed to participate
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Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
15 participants (actual)
Patient registry
No

Groups and cohorts

  • RC Patients

    Patients at the University of Kansas Medical Center who have not yet had their radical cystectomy, after their radical cystectomy, or between the completion of chemotherapy and the radical cystectomy.

    Behavioral: Educational Videos

Interventions

  • BehavioralEducational Videos

    15 videos that are about 3 minutes long each and cover nutritional advice for patients with bladder cancer undergoing RC and/or chemotherapy.

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What researchers measure

Primary outcomes

  1. Evaluate content of three educational video series

    Evaluate the content of three video series focusing on practical solutions to nutritional problems common to patients undergoing a radical cystectomy through iterative process using Center for Disease Control's Clear Communication Index. The Center for Disease Control's Clear Communication Index uses 4 questions and 20 scored items to asses how materials enhance and aid people's understanding of information in seven areas - main message and call to action, language, information design, state of the science, behavioral recommendations, numbers, and risk. The range of scores is 0 to 100 with a score of 90 or higher considered a passing score.

    Time frame: Week 2

  2. Patient Feedback Regarding Videos

    After viewing the videos semi-structure interviews of participants will be conducted to obtain feedback regarding the videos content and design.

    Time frame: Week 2

  3. Patient Attention During Videos

    Eye tracking of participants will be used to assess attention of participants during the videos in order to best understand how participants are viewing the videos and responding to them.

    Time frame: Week 2

  4. Test feedback instrument with patients

    Use a pretest developed instrument measuring nutrition knowledge to test participants knowledge before and after watching the videos

    Time frame: Week 2

  5. Assess implantation of video series

    Online survey of viewers will be used to gain feedback on how the videos were received by those who watched them

    Time frame: Week 2

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Study locations

1 site
  • University of Kansas Medical Center
    Kansas City, Kansas 66160, United States
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Timeline

Tracking 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

Ran from Jun 2018 to primary completion in Dec 2021, 42 months.

Of 159 non-industry observational studies under Urinary Bladder Neoplasms, half reached primary completion within 66 months of starting (the median), counting those still running; a quarter within 34. This study's 42 months is below that.

Counting every sponsor, half of 192 studies reached it within 58 months; a quarter within 34.

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

Registered
Aug 2, 2018
First posted
Jan 14, 2019
StartActual
Jun 28, 2018
Primary completionActual
Dec 31, 2021
CompletionActual
Dec 31, 2021
Last update
May 15, 2023
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.
No changes since tracking began. The registry record was last updated on May 15, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT03801954
Responsible party
Sponsor
First posted
Jan 14, 2019
Start date
Jun 28, 2018
Primary completion
Dec 31, 2021
Completion
Dec 31, 2021
Last update
May 15, 2023

Study contacts

Eugene Lee, MD
principal investigator · University of Kansas Medical Center

Oversight

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

Not currently enrolling

This study is completed, as verified in May 2023. You cannot join it, but the record below documents what was studied.

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