Project Summary  

PCORI has identified the need for large studies that look at real-life questions facing diverse patients, caregivers, and clinicians. In 2014, PCORI launched the Pragmatic Clinical Studies initiative to support large-scale comparative effectiveness studies focusing on everyday care for a wide range of patients. The Pragmatic Clinical Studies initiative funded this research project and others.

This research project is in progress. PCORI will post the research findings on this page within 90 days after the results are final.

What is the research about?

In 2017, more than 58,000 Americans were diagnosed with a type of bladder cancer called non-muscle invasive bladder cancer, or NMIBC. This cancer is limited to the inner layers of the bladder. To treat NMIBC, doctors first remove the tumor, leaving the bladder in place. Then they inject medicine into the bladder.

But NMIBC can come back or get worse. If the cancer comes back or worsens, patients have two treatment options:

• Surgery to remove the bladder. This surgery usually cures the cancer, but it can have side effects like problems with sexual function, and patients may have decreased quality of life.
• Medical management. Taking medicine to destroy cancer cells allows patients to keep their bladders and avoid the side effects of surgery. But this treatment doesn’t work as well as surgery to cure cancer. In some patients, the cancer gets worse and spreads outside the bladder.

In this study, the research team is comparing patients with NMIBC who get surgery to those who choose medical management. The team is asking patients and their caregivers about their experiences and outcomes following treatment.

Who can this research help?

Results may help doctors, patients, and caregivers considering treatment options for recurrent NMIBC.

What is the research team doing?

The research team is enrolling patients with recurrent NMIBC and their caregivers. Patients have chosen either surgery or medical management to treat their cancer.

Patients and caregivers are filling out a survey at the start of the study, several times in the first year, and then yearly for up to three years. The survey asks patients and caregivers about their quality of life and also about financial distress and how they feel about their treatment decision. Patients are answering questions about sexual and bladder function, hospital and urology clinic visits, and if they were able to return to work and normal activities. Caregivers are answering questions about the burden of taking care of the patient. The team is looking at patients’ medical records to see if the cancer came back or got worse, and if patients survived.

The research team is interviewing 50 patients and 25 caregivers to learn more about their experience with treatment and how they chose surgery or medical management.

Patients, caregivers, advocacy organization representatives, guideline developers, and health insurers are helping design the study and choose outcomes important to patients.

Research methods at a glance

Design Elements	Description
Design	Observational: cohort study
Population	900 adults with recurrent high-grade NMIBC that failed first-line treatment with Bacillus Calmette-Guerin and their caregivers
Interventions/ Comparators	Radical cystectomy Medical management
Outcomes	Primary: cancer-related quality of life at 1 year Secondary: Patient: cancer-related quality of life at 4 years, urinary function, sexual function, quality of life, decisional regret, financial distress, healthcare utilization, return to work/normal activities, disease-free survival, metastasis-free survival, progression to muscle-invasive bladder cancer, bladder cancer-specific survival Caregiver: decisional regret, health-related quality of life, caregiver burden, financial distress
Timeframe	1-year follow-up for primary outcomes

More on this Project  

PCORI Stories

Engagement Awards Teams Ride Momentum to Research Projects
Read a feature story that highlights how three Eugene Washington PCORI Engagement Awards teams clinched additional PCORI funding to channel the lessons and successes of their work into three new research projects -- which includes this study -- that answer patient-centered research questions.

Project Details

Principal Investigator

John Gore, MD, MS

Project Status

In progress; Recruiting

Project Title

CISTO: Comparison of Intravesical Therapy and Surgery as Treatment Options for Bladder Cancer

Board Approval Date

August 2018

Project End Date

February 2025

Organization

University of Washington Office of Sponsored Programs, Department of Urology

Year Awarded

2018

State

Washington

Project Type

Research Project

Health Conditions  

Cancer

Bladder Cancer

Multiple/Comorbid Chronic Conditions

Intervention Strategies

Drug Interventions
Other Clinical Interventions

Populations

Racial/Ethnic Minorities
Older Adults
Women
Individuals with Multiple Chronic/co-morbid Conditions

Funding Announcement

Pragmatic Clinical Studies to Evaluate Patient-Centered Outcomes

Project Budget

$8,541,087

Study Registration Information

HSRP20193320

NCT03933826