Implementation of Nutrition Education Videos for Patients Undergoing Radical Cystectomy

Sponsor
University of Kansas Medical Center (Other)
Overall Status
Recruiting
CT.gov ID
NCT03801954
Collaborator
(none)
15
1
42.1
0.4

Study Details

Study Description

Brief 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).

Condition or Disease Intervention/Treatment Phase
  • Behavioral: Educational Videos

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 Design

Study Type:
Observational
Anticipated Enrollment :
15 participants
Observational Model:
Cohort
Time Perspective:
Prospective
Official Title:
Implementation of Nutrition Education Videos for Patients Undergoing Radical Cystectomy
Actual Study Start Date :
Jun 28, 2018
Anticipated Primary Completion Date :
Dec 31, 2021
Anticipated Study Completion Date :
Dec 31, 2021

Arms and Interventions

Arm 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.

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

Outcome Measures

Primary Outcome Measures

  1. Evaluate content of three educational video series [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.

  2. Patient Feedback Regarding Videos [Week 2]

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

  3. Patient Attention During Videos [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.

  4. Test feedback instrument with patients [Week 2]

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

  5. Assess implantation of video series [Week 2]

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

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 University of Kansas Medical Center Kansas City Kansas United States 66160

Sponsors and Collaborators

  • University of Kansas Medical Center

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
University of Kansas Medical Center
ClinicalTrials.gov Identifier:
NCT03801954
Other Study ID Numbers:
  • STUDY00142651
First Posted:
Jan 14, 2019
Last Update Posted:
Apr 19, 2021
Last Verified:
Apr 1, 2021
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by University of Kansas Medical Center
Additional relevant MeSH terms:

Study Results

No Results Posted as of Apr 19, 2021