NCT03801954

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).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
15

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Jun 2018

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 28, 2018

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

August 2, 2018

Completed
6 months until next milestone

First Posted

Study publicly available on registry

January 14, 2019

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2021

Completed
Last Updated

May 15, 2023

Status Verified

May 1, 2023

Enrollment Period

3.5 years

First QC Date

August 2, 2018

Last Update Submit

May 11, 2023

Conditions

Keywords

NutritionDietRadical cystectomy

Outcome Measures

Primary Outcomes (5)

  • 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.

    Week 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.

    Week 2

  • 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.

    Week 2

  • Test feedback instrument with patients

    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

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

    Week 2

Study Arms (1)

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

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

RC Patients

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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.

You may qualify if:

  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Kansas Medical Center

Kansas City, Kansas, 66160, United States

Location

MeSH Terms

Conditions

Urinary Bladder Neoplasms

Condition Hierarchy (Ancestors)

Urologic NeoplasmsUrogenital NeoplasmsNeoplasms by SiteNeoplasmsFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesUrinary Bladder DiseasesUrologic DiseasesMale Urogenital Diseases

Study Officials

  • Eugene Lee, MD

    University of Kansas Medical Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 2, 2018

First Posted

January 14, 2019

Study Start

June 28, 2018

Primary Completion

December 31, 2021

Study Completion

December 31, 2021

Last Updated

May 15, 2023

Record last verified: 2023-05

Locations