Implementation of Nutrition Education Videos for Patients Undergoing Radical Cystectomy

May 11, 2023 updated by: University of Kansas Medical Center
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).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Observational

Enrollment (Actual)

15

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

    • Kansas
      • Kansas City, Kansas, United States, 66160
        • University of Kansas Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

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.

Description

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:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Evaluate content of three educational video series
Time Frame: Week 2
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.
Week 2
Patient Feedback Regarding Videos
Time Frame: Week 2
After viewing the videos semi-structure interviews of participants will be conducted to obtain feedback regarding the videos content and design.
Week 2
Patient Attention During Videos
Time Frame: Week 2
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.
Week 2
Test feedback instrument with patients
Time Frame: Week 2
Use a pretest developed instrument measuring nutrition knowledge to test participants knowledge before and after watching the videos
Week 2
Assess implantation of video series
Time Frame: Week 2
Online survey of viewers will be used to gain feedback on how the videos were received by those who watched them
Week 2

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Eugene Lee, MD, University of Kansas Medical Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 28, 2018

Primary Completion (Actual)

December 31, 2021

Study Completion (Actual)

December 31, 2021

Study Registration Dates

First Submitted

August 2, 2018

First Submitted That Met QC Criteria

January 9, 2019

First Posted (Actual)

January 14, 2019

Study Record Updates

Last Update Posted (Actual)

May 15, 2023

Last Update Submitted That Met QC Criteria

May 11, 2023

Last Verified

May 1, 2023

More Information

Terms related to this study

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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