- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03801954
Implementation of Nutrition Education Videos for Patients Undergoing Radical Cystectomy
Study Overview
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
Enrollment (Actual)
Contacts and Locations
Study Contact
- Name: Katie Glavin
- Phone Number: 913-588-8721
- Email: kglavin@kumc.edu
Study Locations
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Kansas
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Kansas City, Kansas, United States, 66160
- University of Kansas Medical Center
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Sampling Method
Study Population
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
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.
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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 is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Evaluate content of three educational video series
Time Frame: Week 2
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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.
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Week 2
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Patient Feedback Regarding Videos
Time Frame: Week 2
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After viewing the videos semi-structure interviews of participants will be conducted to obtain feedback regarding the videos content and design.
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Week 2
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Patient Attention During Videos
Time Frame: Week 2
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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.
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Week 2
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Test feedback instrument with patients
Time Frame: Week 2
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Use a pretest developed instrument measuring nutrition knowledge to test participants knowledge before and after watching the videos
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Week 2
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Assess implantation of video series
Time Frame: Week 2
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Online survey of viewers will be used to gain feedback on how the videos were received by those who watched them
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Week 2
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Collaborators and Investigators
Investigators
- Principal Investigator: Eugene Lee, MD, University of Kansas Medical Center
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- STUDY00142651
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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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