Bladder CancerNCT03801954
Implementation of Nutrition Education Videos for Patients Undergoing Radical Cystectomy
An observational study of Bladder Cancer, run by University of Kansas Medical Center at 1 site in United States.
Trial 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 more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Bladder Cancer
- What is being tested?
- Educational Videos
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 15 participants
- Where
- 1 siteUnited States
- Study dates
- 28 Jun 2018to 31 Dec 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients who present to the University of Kansas Urology clinic for bladder cancer will be screened for participation in the study.
Who may be able to join
- 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
Who cannot join
- 1. Patients who are under 18 years old are not allowed to participate
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Kansas Medical Center
Kansas City, Kansas, 66160
About this study
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.
- Conditions
- Bladder Cancer
- Being tested
- Educational Videos
- Keywords
- Nutrition, Diet, Radical cystectomy
- Medical subject headings
- Urinary Bladder Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Educational VideosBehavioural
15 videos that are about 3 minutes long each and cover nutritional advice for patients with bladder cancer undergoing RC and/or chemotherapy.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: Educational Videos |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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
Measured: 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
Measured: Week 2
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jan 2019
- Study start28 Jun 2018
- Primary completion31 Dec 2021
- Study completion31 Dec 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bladder CancerStudies of the same condition, open and under way.
- More trials run by University of Kansas Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Kansas Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Eugene Lee, MD, Principal investigator, University of Kansas Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03801954
- Sponsor's protocol ID
- STUDY00142651
- Status last verified
- May 2023
- First submitted
- 2 Aug 2018
- Last updated
- 15 May 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Implementation of Nutrition Education Videos for Patients Undergoing Radical Cystectomy
- ClinicalTrials.gov ID
- NCT03801954
- Acronym / sponsor ID
- STUDY00142651
- Conditions
- Bladder Cancer
- Keywords
- Nutrition, Diet, Radical cystectomy
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 15 participants (actual)
- Lead sponsor
- University of Kansas Medical CenterUniversity, hospital or other
- Study start
- 28 Jun 2018 (actual)
- Primary completion
- 31 Dec 2021 (actual)
- Study completion
- 31 Dec 2021 (actual)
- First posted
- 14 Jan 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
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
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| RC Patients | – | Behavioral: Educational VideosPatients 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients who present to the University of Kansas Urology clinic for bladder cancer will be screened for participation in the study.
Key inclusion criteria (1 listed)
- 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
Key exclusion criteria (1 listed)
- 1. Patients who are under 18 years old are not allowed to participate
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Educational Videos15 videos that are about 3 minutes long each and cover nutritional advice for patients with bladder cancer undergoing RC and/or chemotherapy. | Behavioural | RC Patients |
Primary outcome
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.
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.
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.
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
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 May 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Eugene Lee, MD principal investigator
University of Kansas Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Bladder Cancer, run by University of Kansas Medical Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 May 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Evaluate content of three educational video series (time frame: Week 2). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 May 2023.