Comparison of Intravesical Therapy and Surgery as Treatment Options for Bladder Cancer 2
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorUniversity of Washington
About this trial
Bladder cancer is the most common urinary tract cancer and the 6th most common cancer in the US. Yet bladder cancer research is underfunded relative to other common cancers. As a result, bladder cancer care is prone to evidence gaps that produce decision uncertainty for both patients and clinicians. The Comparison of Intravesical Therapy and Surgery as Treatment Options for Bladder Cancer Study 2 (CISTO2) has the potential to fill these critical evidence gaps, change care pathways for the management of NMIBC (non-muscle-invasive bladder cancer), and provide for personalized, patient-centered care. The purpose of CISTO2 is to conduct a large prospective study that directly compares the impact of bladder sparing therapies versus bladder removal in recurrent high-grade NMIBC patients on financial toxicity, clinical outcomes and patient and caregiver experience using standardized patient-reported outcomes (PROs).
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Adult 18 years of age or older; and
Pathology documentation from any hospital/clinic/medical center
More than 50% urothelial carcinoma component in the specimen; and
History of high-grade NMIBC established by anatomic pathology as tumor stage classification Tis, Ta, or T1; and
Disqualifiers
Any plasmacytoid or small cell (neuroendocrine) component in the pathology (past or current presentation);
Previous history of cystectomy or radiation therapy for bladder cancer;
Previous history of muscle-invasive bladder cancer or metastatic bladder cancer;
Untreated or current urinary tract urothelial carcinoma outside of the bladder (e.g. ureters, renal pelvis, penile urethra for males, urethra for females). Urinary tract cancer outside of the bladder treated more than 2 years ago is not an exclusion;
Trial population
Patients with a diagnosis of recurrent high-grade NMIBC who are considering their next treatment will be approached for participation in this observational study in addition to their caregivers.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Not listed
Trial groups
408 Participants
are grouped into 4 trial groupsGroup A: Patients who have selected radical cystectomy
Group B: Patients who have selected bladder-sparing therapy
Group C: Caregivers of patients who have selected radical cystectomy
Group D: Caregivers of patients who have selected bladder-sparing therapy
Trial outcomes
Primary outcomes
1
Patient-reported financial toxicity as measured by the COmprehensive Score for financial Toxicity (COST)
The primary outcome of patient-reported financial toxicity is measured by the COST measure. The questionnaire consists of 11 items, each scored on a 5-point Likert scale from zero to four. After reversing some items as indicated in the scoring manual (by reversing the sign on the original zero to four score and adding four), all item response scores are summed into a single financial toxicity score ranging from 0 to 44, with higher scores indicating less financial toxicity. Item nonresponse is accounted for by summing the items answered, multiplying by the total number of items in the scale, and then dividing by the number of items that were actually answered.
Time frame
12 months after enrollmentSecondary outcomes
1
Patient-reported financial toxicity as measured by the COmprehensive Score for financial Toxicity (COST)
Patient-reported financial toxicity is measured by the COST measure. The questionnaire consists of 11 items, each scored on a 5-point Likert scale from zero to four. After reversing some items as indicated in the scoring manual (by reversing the sign on the original zero to four score and adding four), all item response scores are summed into a single financial toxicity score ranging from 0 to 44, with higher scores indicating less financial toxicity. Item nonresponse is accounted for by summing the items answered, multiplying by the total number of items in the scale, and then dividing by the number of items that were actually answered.
Time frame
24 months after enrollment2
Caregiver self-reported financial distress as measured by the modified Comprehensive Score for Financial Toxicity (COST)
Caregiver-reported financial toxicity is measured by the COST measure. The questionnaire consists of 12 items, each scored on a 5-point Likert scale from zero to four. After reversing some items as indicated in the scoring manual (by reversing the sign on the original zero to four score and adding four), all item response scores are summed into a single financial toxicity score ranging from 0 to 44, with higher scores indicating less financial toxicity. Item nonresponse is accounted for by summing the items answered, multiplying by the total number of items in the scale, and then dividing by the number of items that were actually answered.
Time frame
12 months after enrollment3
Patient self-reported financial well-being as measured by the Consumer Financial Protection Bureau (CFPB) Financial Well-Being Scale
Patient-reported financial well-being is measured by the CFPB financial well-being scale. The scale consists of 10 items plus 2 questions to assist with scoring. Total response values are converted into an overall financial well-being score between 0 to 100, with higher scores indicating better financial wellness. The financial well-being scores vary based on age and how the questionnaire was administered.
Time frame
12 months after enrollment4
Caregiver self-reported financial well-being as measured by the Consumer Financial Protection Bureau (CFPB) Financial Well-Being Scale
Caregiver-reported financial well-being is measured by the CFPB financial well-being scale. The scale consists of 10 items plus 2 questions to assist with scoring. Total response values are converted into an overall financial well-being score between 0 to 100, with higher scores indicating better financial wellness. The financial well-being scores vary based on age and how the questionnaire was administered.
Time frame
12 months after enrollmentSponsors and contacts
Click on the lead sponsor to view all of their trials.
University of Washington
Lead sponsor
National Cancer Institute (NCI)
Collaborator
Source ClinicalTrials.gov