Support Tool for Bladder Cancer

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Roswell Park Cancer Institute

Must be taking: Systemic therapy

Disqualifiers: Small cell histology, Pregnancy, others

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

Compensation: Varies

Number of Visits: 3

160 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores how an education and navigation support tool (ENST) can assist patients and their caregivers in managing advanced bladder cancer. The researchers aim to enhance patient and caregiver involvement in treatment decisions and care planning. Patients with bladder cancer that has spread or cannot be removed by surgery, and who are receiving treatment at Roswell Park Comprehensive Cancer Center, might find this trial suitable. Participants will have access to support group meetings and consultations to address psychological and nutritional needs. As an unphased trial, this study provides a unique opportunity to enhance the care experience through innovative support tools.

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 using a support tool for patients receiving systemic therapy for bladder cancer.

What prior data suggests that this education and navigation support tool is safe for patients with advanced bladder cancer?

Research has shown that education and support tools, like the one being studied, are generally safe and easy to use. These tools aim to enhance understanding and involvement in care, rather than directly affecting the body. Previous studies on similar software tools have demonstrated that they can help patients learn more about their condition and make healthier choices without causing harm.

Patient navigation programs, similar to this support tool, are designed to help manage care more effectively. These programs are considered safe and aim to simplify access to healthcare. No reports of negative side effects from using these types of tools suggest they are safe for participants. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Education and Navigation Support Tool (ENST) for bladder cancer because it takes a comprehensive approach that goes beyond traditional medical treatments like surgery, chemotherapy, and immunotherapy. Unlike standard treatments, ENST offers educational resources and psychological support specifically tailored for patients and caregivers, addressing emotional and nutritional needs. This holistic approach not only helps manage psychological distress but also provides a platform for virtual support group meetings, fostering a community and improving overall patient experience.

What evidence suggests that this education and navigation support tool is effective for bladder cancer?

Previous studies have shown that education and navigation support tools (ENSTs) help patients and caregivers actively manage their care. Research indicates that these tools improve decision-making and care planning, particularly for complex conditions like advanced bladder cancer. This trial will evaluate the effectiveness of the ENST for bladder cancer, aiming to empower patients and caregivers with clear guidance and information. This approach may lead to better management of the condition and improved quality of life. Although specific data for bladder cancer is limited, similar tools in other cancers have made patients feel more informed and supported. ^{1 2 6 7 8}

Who Is on the Research Team?

Saby George, MD

Principal Investigator

Roswell Park Cancer Institute

Are You a Good Fit for This Trial?

This trial is for patients with bladder cancer that's spread or can't be removed by surgery, and their caregivers. It aims to help those who are older, have multiple health issues, and struggle with healthcare access.

Inclusion Criteria

I am a caregiver and I am 18 years old or older.

Caregivers will be enrolled in the genitourinary (GU) clinic during the same time window as for patient enrollment (from initial visit to within 8 weeks of patients starting frontline therapy)

I was diagnosed with advanced bladder cancer recently or started treatment less than 8 weeks ago.

Exclusion Criteria

I am unable to make decisions or participate in surveys due to my condition.

I have difficulty making decisions due to cognitive impairment.

My cancer is mainly small cell type.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Implementation

Development and delivery of the Education and Navigation Support Tool (ENST) for patients and caregivers

6 months

Periodic virtual support group meetings

Follow-up

Participants are monitored for perceptions of care coordination and self-efficacy

6 months

Assessments at baseline, 3 months, and 6 months

What Are the Treatments Tested in This Trial?

Interventions

• Education and Navigation Support Tool

Trial Overview The study tests an education and navigation support tool (ENST) designed to boost patient and caregiver involvement in managing advanced bladder cancer treatment plans and decision-making.

How Is the Trial Designed?

Group I: Supportive Care (ENST) Experimental Treatment 5 Interventions

Patients and caregivers receive access to the bladder cancer ENST and patients undergo psychological distress and nutrition screenings and may attend social work, psychology, and/or nutrition consultations as appropriate throughout the study. Patients, caregivers, and providers also attend virtual support group meetings periodically on study.

Who Is Running the Clinical Trial?

Roswell Park Cancer Institute

Lead Sponsor

Trials

427

Recruited

40,500+

Published Research Related to This Trial

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]

The study aims to create a living systematic review and open-access evidence map for surgical therapies in bladder cancer, which will help healthcare providers and patients stay updated with the latest research findings.

This evidence map will facilitate better decision-making by identifying research gaps and avoiding redundant studies, ultimately improving the planning and execution of future clinical trials.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Framework for a living systematic review and meta-analysis for the surgical treatment of bladder cancer: introducing EVIglance to urology. Wieland, VLS., Uysal, D., Probst, P., et al.[2023]

A study involving 34 Canadian physicians identified key barriers to chemotherapy use for muscle-invasive bladder cancer, including skepticism about its benefits, poor multidisciplinary collaboration, and unclear referral processes.

Enablers for chemotherapy use included having advocates or 'champions' for its value, consistent referrals from urologists to medical oncologists, and system-level improvements like automatic multidisciplinary referrals.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Perioperative chemotherapy for bladder cancer: A qualitative study of physician knowledge, attitudes, and behaviour. Walker, M., Doiron, RC., French, SD., et al.[2022]

In a randomized controlled trial involving 319 patients with breast and colorectal cancer, patient navigation did not show a statistically significant effect on cancer-specific quality of life (QOL) compared to usual care.

While the emotional well-being of the patient navigation group showed a change that approached significance, overall QOL measures did not differ significantly, suggesting that patient navigation may not enhance QOL during cancer treatment in this study's context.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Randomized controlled trial of patient navigation for newly diagnosed cancer patients: effects on quality of life. Hendren, S., Griggs, JJ., Epstein, R., et al.[2021]

Patient navigation (PN) significantly reduced the time from definitive diagnosis to initiation of therapy for breast cancer, with an average of 57 days for the PN group compared to 74 days for the control group, indicating improved efficiency in cancer care.

Hispanic women who received PN were more likely to be diagnosed and start treatment within 60 days of abnormal screening tests, highlighting PN's potential to address health disparities in minority populations.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Beneficial effects of a combined navigator/promotora approach for Hispanic women diagnosed with breast abnormalities. Dudley, DJ., Drake, J., Quinlan, J., et al.[2021]

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]

The study developed and validated the Patient Satisfaction with Navigation, Logistical measure, which assesses patient navigation experiences in cancer treatment, using data from 1,873 diverse participants.

The measure demonstrated strong psychometric properties, providing reliable and precise scores for evaluating patient satisfaction with navigation services, which can help improve cancer care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Psychometric evaluation of the patient satisfaction with logistical aspects of navigation (PSN-L) scale using item response theory. Carle, AC., Jean-Pierre, P., Winters, P., et al.[2021]

Nurse navigation in cancer care has been associated with significant improvements in clinical outcomes, including reduced distress, anxiety, and depression among patients.

Patients receiving nurse navigation experienced better symptom management, improved physical conditioning, enhanced quality of life, and quicker initiation of treatment, highlighting the effectiveness of this approach in cancer care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Clinical outcomes of patient navigation performed by nurses in the oncology setting: an integrative review. Rodrigues, RL., Schneider, F., Kalinke, LP., et al.[2022]

The management principles for bladder cancer remain consistent across all age groups, meaning that older patients should receive the same treatment options as younger patients, regardless of their age.

For patients with muscle-invasive bladder cancer (MIBC), a geriatric multidisciplinary approach can improve prognosis, suggesting that individual assessments of older patients' health are crucial before deciding on treatments like chemotherapy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Optimizing the management of bladder cancer in older patients]. Neuzillet, Y., Geiss, R., Paillaud, E., et al.[2020]

A study involving 251 adults with newly diagnosed breast, colorectal, or lung cancer found that nurse navigator support significantly improved patient experience, particularly in psychosocial care and care coordination, compared to enhanced usual care.

While there were no significant differences in overall quality of life scores between the two groups, patients with lung cancer who received nurse navigator support had lower cumulative healthcare costs by $6,852.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Nurse navigators in early cancer care: a randomized, controlled trial. Wagner, EH., Ludman, EJ., Aiello Bowles, EJ., et al.[2021]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT06414317

Study Details | NCT06414317 | An Education and ... This clinical trial evaluates the impact of an education and navigation support tool (ENST) on patient and caregiver participation in care coordination for ...

2. withpower.com withpower.com/trial/phase-carcinoma-2024-4f153

Support Tool for Bladder Cancer This clinical trial evaluates the impact of an education and navigation support tool (ENST) on patient and caregiver participation in care coordination for ...

3. urotoday.com urotoday.com/center-of-excellence/bladder-cancer/from-the-editor/160594-beyond-survival-advancing-patient-centric-bladder-cancer-care.html

Advancing Patient-Centric Bladder Cancer Care Bladder cancer rates have risen in this population in recent decades, and these patients face unique challenges such as career disruption and ...

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10337367/

Cancer Resource and Information Support (CRIS) for ... The purpose of this manuscript is to report on the development and usability testing of the CRIS software.

5. onclive.com onclive.com/view/real-world-data-help-fill-the-gaps-left-by-clinical-trial-results-in-urothelial-carcinoma

Real-World Data Help Fill the Gaps Left by Clinical Trial ... David J. Benjamin, MD, discusses how he uses real-world data to supplement clinical trial results in urothelial carcinoma.

6. foxchase.org foxchase.org/discovery-kutikov-zibelman

INSITE Study Aims to Pinpoint Bladder Cancer Patients ... Kutikov and Zibelman acknowledge that no tool can offer 100 percent certainty that all cancer has been cleared from the bladder. But with data from this trial — ...

7. auajournals.org auajournals.org/doi/10.1097/JU.0000000000004296

A Single-Arm, Open-Label, Phase 3 Trial (ENVISION) Primary chemoablation with UGN-102 in patients with recurrent low-grade intermediate-risk nonmuscle-invasive bladder cancer resulted in an 80% CR rate.

8. onlinelibrary.wiley.com onlinelibrary.wiley.com/doi/10.1002/9781118674826.ch32

Patient navigation and cancer navigator programs This chapter describes the purpose and objective of patient navigation programs, reviews observed health disparities in bladder cancer care ...