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

Trial Summary

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 data supports the effectiveness of the treatment Education and Navigation Support Tool for bladder cancer?

Research shows that patient navigation, which includes educational and emotional support, can improve the quality of life and patient experience for people with various types of cancer. This suggests that similar support tools could be beneficial for bladder cancer patients as well. ^{1 2 3 4 5}

What makes the Support Tool for Bladder Cancer treatment unique?

The Support Tool for Bladder Cancer treatment is unique because it involves a tailored 'explanimation' video, which is an audio-visual tool designed to provide personalized information to patients before and during their treatment, enhancing their understanding and potentially improving their treatment experience. ^{6 7 8 9 10}

What is the purpose of this trial?

This clinical trial evaluates the impact of an education and navigation support tool (ENST) on patient and caregiver participation in care coordination for bladder cancer that has spread to nearby tissue or lymph nodes (locally advanced), to other places in the body (metastatic) or that cannot be removed by surgery (unresectable). Patients with advanced bladder cancer tend to be older, have multiple medical conditions and often have poor access to health care. An ENST may be an effective method to improve participation in treatment decision-making and care planning among patients with locally advanced, metastatic and unresectable bladder cancer and their caregivers.

Research Team

Saby George, MD

Principal Investigator

Roswell Park Cancer Institute

Eligibility Criteria

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.

I am not on any bladder cancer treatment due to my health or organ function.

Timeline

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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]

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]

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 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]

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 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]

References

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

Psychometric evaluation of the patient satisfaction with logistical aspects of navigation (PSN-L) scale using item response theory. [2021]

2. Brazil pubmed.ncbi.nlm.nih.gov

Clinical outcomes of patient navigation performed by nurses in the oncology setting: an integrative review. [2022]

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

Randomized controlled trial of patient navigation for newly diagnosed cancer patients: effects on quality of life. [2021]

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

Beneficial effects of a combined navigator/promotora approach for Hispanic women diagnosed with breast abnormalities. [2021]

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

Nurse navigators in early cancer care: a randomized, controlled trial. [2021]

6. 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]

7. England pubmed.ncbi.nlm.nih.gov

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

8. England 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. [2023]

9. France pubmed.ncbi.nlm.nih.gov

[Optimizing the management of bladder cancer in older patients]. [2020]

10. Canada pubmed.ncbi.nlm.nih.gov

Perioperative chemotherapy for bladder cancer: A qualitative study of physician knowledge, attitudes, and behaviour. [2022]