Educational Videos and Questionnaires for Bladder Cancer

Overseen By Piyush K Agarwal, MD

Age: 65+

Sex: Any

Trial Phase: Academic

Sponsor: University of Chicago

Disqualifiers: Non-oncologic cystectomy, other cancers

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 3

85 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This study focuses on providing an educational program for people/participants with bladder cancer who plan to have a cystectomy (surgery) as part of their standard care. Participants in this study will watch videos designed to teach them strategies to help lower their risk of experiencing negative side effects (such as mobility problems, issues with taking medication, and poor quality of life) before and after they have surgery. They will also be asked to fill out questionnaires.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It focuses on educational videos and questionnaires for bladder cancer patients undergoing surgery.

Is the educational video program for bladder cancer patients safe?

The research does not provide specific safety data for the educational video program, but similar educational tools and programs for bladder cancer patients have been used to improve care and support without reported safety concerns. ^{1 2 3 4 5}

How does the educational video treatment for bladder cancer differ from other treatments?

This treatment is unique because it uses educational videos and questionnaires to help patients understand and manage their bladder cancer, focusing on improving their quality of life and self-management skills, unlike traditional treatments that primarily focus on medical interventions. ^{1 2 4 6 7}

What data supports the effectiveness of the treatment Educational Video Modules on Risk Prevention Before and After Cystectomy for bladder cancer patients?

Research shows that educational programs, including videos, can help bladder cancer patients better manage their condition and reduce complications after surgery. These programs provide important information and support, which can improve patients' ability to care for themselves and reduce hospital readmissions. ^{1 4 5 6 8}

Who Is on the Research Team?

Piyush Agarwal

Principal Investigator

University of Chicago

Are You a Good Fit for This Trial?

This trial is for individuals with bladder cancer who are scheduled to undergo a radical cystectomy. Participants should be willing to engage with educational materials and complete questionnaires as part of the study.

Inclusion Criteria

I am having a major bladder surgery for cancer at the University of Chicago.

I am 65 years old or older.

I am able to understand and agree to the study's requirements.

Exclusion Criteria

I had bladder removal surgery not for cancer reasons.

I am having or had a surgery to remove my bladder for cancer not originating from it.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Pre-Surgery Education

Participants attend educational sessions and watch videos on strategies to reduce mobility loss, improve medication management, and prevent delirium before surgery.

2 weeks

1 visit (in-person)

Surgery and Immediate Post-Surgery

Participants undergo radical cystectomy and receive immediate post-surgery care.

1 week

Post-Surgery Follow-up

Participants receive follow-up visits to reinforce strategies learned in the educational session and plan hospital discharge.

4 weeks

2 visits (in-person)

Long-term Follow-up

Participants are monitored for hospital readmission rates and complication rates up to 90 days post-surgery.

90 days

What Are the Treatments Tested in This Trial?

Interventions

• Educational Video Modules on Risk Prevention Before and After Cystectomy

Trial Overview The study tests an educational program consisting of video modules on risk prevention, aimed at reducing post-surgery complications like mobility issues and medication problems, along with geriatric service planning.

How Is the Trial Designed?

Group I: Participants Who Watch Educational Videos Before Surgery and Receive Geriatric Follow Up Services Experimental Treatment 3 Interventions

Participants in this group will also attend an educational session in a conference room that includes 4 learning modules on strategies to reduce mobility loss, improve medication management, prevent delirium, and to document what matters most before and after surgery (cystectomy). These learning modules will be in video format. Participants will watch videos to learn about pre/post surgical strategies and they will receive informational handouts after watching the videos. The study team will also ask participants to fill out questionnaires/surveys before surgery. In addition to attending the educational program (via video) and receiving informational handouts, participants in this group will also meet with the study doctor and/or members of the study team after surgery to help plan their hospital discharge and reinforce/use the strategies they learned in the educational session after surgery.

Group II: Participants Who Watch Educational Videos Before Surgery Experimental Treatment 2 Interventions

Participants in this group will attend an educational session in a conference room that includes 4 learning modules on strategies to reduce mobility loss, improve medication management, prevent delirium, and to document what matters most before and after surgery (cystectomy). These learning modules will be in video format. Participants will watch videos to learn about pre/post surgical strategies and they will receive informational handouts after watching the videos. The study team will also ask participants to fill out questionnaires/surveys before and after surgery.

Who Is Running the Clinical Trial?

University of Chicago

Lead Sponsor

Trials

1,086

Recruited

844,000+

Published Research Related to This Trial

A preoperative ostomy education program significantly helps bladder cancer patients and their caregivers by addressing their fears and knowledge gaps about ostomy surgery, motivating them to participate in their care.

The program's interactive curriculum, particularly the involvement of a patient advocate, was found to be effective in preparing participants for self-management and adapting to life post-ostomy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A qualitative evaluation of a nurse-led pre-operative stoma education program for bladder cancer patients. Wulff-Burchfield, EM., Potts, M., Glavin, K., et al.[2022]

A scoping review of 3,197 articles identified 42 relevant studies highlighting the need for cognitive, psychological, and functional support for urological patients undergoing surgeries like prostatectomy, cystectomy, and nephrectomy.

Various educational strategies, such as informational brochures, preoperative counseling, and online content, can effectively help patients manage the negative effects of their conditions and treatments, empowering them to take charge of their disease management.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Empowerment-Based Education in Urological Patients: A Scoping Review. Villa, G., Galli, E., Azzimonti, V., et al.[2022]

Radical cystectomy, a surgery for bladder cancer, is often avoided due to its high complication rates, highlighting the need for improved perioperative care.

The seminar discusses effective interventions such as nutritional support, patient education, and technology use that can enhance the care of patients undergoing this procedure, making it more accessible and safer.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Perioperative optimization of the genitourinary oncology patient. Holzbeierlein, JM.[2022]

The internet-based mobile health tool for patients after cystectomy was found to be feasible and acceptable, with 90% of patients using it within the first week post-discharge, although engagement decreased to 50% over time due to technological issues.

Despite high patient satisfaction (over 90%), the use of the tool did not show a statistically significant association with reduced readmission rates, indicating that further research is needed to assess its effectiveness in improving patient outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Feasibility, Acceptability, and Outcomes of a Mobile Health Tool for Radical Cystectomy Recovery. Weiss, K., Abimbola, O., Mueller, D., et al.[2023]

A pilot study involving 20 participants undergoing radical cystectomy demonstrated that using a health care application for patient education and monitoring is feasible, with 15 participants completing the study.

The application led to timely interventions for 4 participants who required outpatient treatment, suggesting that enhanced monitoring could potentially reduce hospital readmissions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Feasibility of a Health Care Application in the Treatment of Patients Undergoing Radical Cystectomy. Metcalf, M., Glazyrine, V., Glavin, K., et al.[2019]

Post-operative education about bladder cancer and topical immunotherapy significantly impacts the psychological and social well-being of patients, as they experience intense distress upon diagnosis despite the cancer's curability.

Quality of life improves during maintenance therapy with bacille Calmette-Guérin (BCG), indicating that ongoing support and education from urologists are crucial for helping patients manage their condition and improve their overall health.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Quality of life in patients undergoing bacille Calmette-Guérin therapy for superficial bladder cancer. Mack, D., Frick, J.[2019]

Hospital acquired adverse events occurred in 11.3% of patients undergoing radical cystectomy, significantly increasing the risk of in-hospital mortality (8.07 times higher) and leading to longer hospital stays (41.3% longer) and higher costs ($54,242 compared to $26,306).

Postoperative sepsis was particularly dangerous, associated with the highest mortality risk (17.56 times higher), a predicted length of stay increase of 62.22%, and the highest total hospitalization costs ($79,613), highlighting the need for improved patient safety measures.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The implications of hospital acquired adverse events on mortality, length of stay and costs for patients undergoing radical cystectomy for bladder cancer. Kim, SP., Shah, ND., Karnes, RJ., et al.[2022]

A tailored 'explanimation' video (EV) was found to be user-friendly and effective in helping bladder cancer patients understand their treatment options and make informed decisions, based on interviews with 12 patients.

While the EV was generally well-received, patients noted a need for more practical information about 'life after treatment' and emphasized the importance of delivering the video at the right time during their treatment process.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Patients' experiences with an audio-visual intervention, the use of a tailored explanimation video in patients with bladder cancer. Wolters-Zwolle, M., de Jongh, MME., van Elst, MW., et al.[2023]

Citations

1. Germany pubmed.ncbi.nlm.nih.gov

A qualitative evaluation of a nurse-led pre-operative stoma education program for bladder cancer patients. [2022]

2. United States pubmed.ncbi.nlm.nih.gov

Empowerment-Based Education in Urological Patients: A Scoping Review. [2022]

3. United States pubmed.ncbi.nlm.nih.gov

Perioperative optimization of the genitourinary oncology patient. [2022]

4. United States pubmed.ncbi.nlm.nih.gov

Feasibility, Acceptability, and Outcomes of a Mobile Health Tool for Radical Cystectomy Recovery. [2023]

5. United States pubmed.ncbi.nlm.nih.gov

The Feasibility of a Health Care Application in the Treatment of Patients Undergoing Radical Cystectomy. [2019]

6. England pubmed.ncbi.nlm.nih.gov

Quality of life in patients undergoing bacille Calmette-Guérin therapy for superficial bladder cancer. [2019]

7. United States pubmed.ncbi.nlm.nih.gov

The implications of hospital acquired adverse events on mortality, length of stay and costs for patients undergoing radical cystectomy for bladder cancer. [2022]

8. Netherlands pubmed.ncbi.nlm.nih.gov

Patients' experiences with an audio-visual intervention, the use of a tailored explanimation video in patients with bladder cancer. [2023]