Non-Muscle Invasive Bladder Carcinoma
Conditions
Brief summary
This phase IV trial studies whether there is a relationship between how a patient is positioned while receiving bacillus Calmette Guerin (BCG) within the bladder (intravesical) and how long BCG stays in the bladder (dwell time) to improve the treatment of non-muscle invasive bladder cancer. For the past 40 years, intravesical BCG has been used for the treatment of non-muscle invasive bladder cancer. An important factor for BCG treatment is the dwell time, which is the period of time a patient can hold the BCG medication in the bladder after it has been given. Normally, patients are instructed during intravesical BCG treatment to avoid emptying the bladder for 2 hours after the BCG is given. However, this may be difficult for some patients who may have limited bladder capacity, restricted movement, or severe urinary symptoms. There have been studies outlining the relationship with increased dwell time and how well the treatment works, but studies on the potential impact of patient positioning or activity on the patient's ability to retain the drug are limited. Researchers hope by studying whether there is a relationship between patient positioning during intravesical BCG treatment and dwell time, they may be able to improve how BCG treatment for non-muscle invasive bladder cancer is given, especially for patients with limited bladder capacity, restricted movement, or severe urinary symptoms.
Detailed description
PRIMARY OBJECTIVES: I. To assess the relationship between bacillus Calmette Guerin (BCG) dwell time and patient position in subjects with intermediate risk (IR) and high risk (HR) non-muscle-invasive bladder cancer (NMIBC). II. To assess the feasibility of a fitness tracker for remote capture of patient vitals and mobility during intravesical BCG treatment. OUTLINE: Patients receive standard of care (SOC) BCG therapy once a week (QW) and post-treatment activity guidance for the first three weekly BCG installations in the absence of disease progression or unacceptable toxicity. FIRST TREATMENT: Patients receive SOC BCG intravesically and instructions to avoid urination for two hours with no activity restrictions and immediate clinic discharge. SECOND TREATMENT: Patients receive SOC BCG intravesically and remain in a lying down position for as long as able to hold treatment in for up to 2 hours. THIRD TREATMENT: Patients receive SOC BCG intravesically and remain in a sitting position for as long as able to hold treatment in for up to 2 hours. Additionally, patients receive and wear a Fitbit activity tracker throughout the study.
Interventions
PROCEDUREAccelerometry
Receive and wear Fitbit
BIOLOGICALBCG Solution
Given intravesically with no activity restrictions
OTHERElectronic Health Record Review
Ancillary studies
BEHAVIORALPatient Discharge
Receive immediate clinic discharge
OTHERSurvey Administration
Ancillary studies
Sponsors
Ohio State University Comprehensive Cancer Center
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Patient with intermediate or high risk NMIBC opting for intravesical induction BCG * Has not initiated induction therapy * Able to remain in supine position for two hours. (Head may be raised on up to two pillows) * Able to remain in a sitting position for two hours * Willingness to utilize a wearable fitness tracker for at least five days during the study * Able to perform a remote video or telephone encounter * Able to provide informed consent
Exclusion criteria
* Receipt of intravesical BCG within the past 1 year * Known inability to retain BCG * History of urinary incontinence with a score of 3 or more on the Overactive Bladder Survey (OAB) urgency, urgency incontinence, or incontinence questions * Refusal to wear a fitness tracker during a 24-hour baseline, during treatment, and/or for 2 hours post treatment
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Bacillus Calmette Guerin (BCG) dwell time | From the instillation of the drug to the void time or 2 hours, whichever is earlier, assessed up to 5 weeks | Will be measured on the same participant under three test positions (ad lib, supine, and seated). A generalize linear mixed model for correlated data will be used to compare the three test conditions. Dwell time will be modeled as a function of test condition and any other covariates (i.e. patient characteristics and/or environmental aspects) thought to be related to dwell time. Interaction effects with test condition will be considered. If a majority of participants (\> 75%; n = 10) have dwell times of 2 hours, the statistical method used to compare the 3 test conditions will be changed. To determine factors that impact the ability to maintain the BCG for two hour, a generalized estimating equation (GEE) model will be used. The outcome of interest will be a binomial indicator of dwell time equal to (coded as 1) or less than (coded as 0) 2 hours. Covariates will include all patient characteristics, and any environmental aspects suspected of influencing dwell time. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Probability of maintaining BCG for at least 1 hour | From the instillation of the drug up to 1 hour, assessed up to 5 weeks | The probability of maintaining the BCG for at least 1 hour for each test position will be compared using a GEE model. Any patient or environmental characteristics felt to impact on dwell time will be included as covariates in the GEE model. |
| Compliance with study instructions | Up to 5 weeks | Compliance with study instructions (supine and seated positions only) will be measured using the Fitbit's count of number of steps taken and nursing staff observation. Compliance will be defined as zero or \> zero steps (i.e. a binomial variable) during the test session. A GEE model will be constructed to compare each positions probability of remaining compliant. |
| Compliance to Fitbit tracking | From appointment arrival until first void, assessed up to 5 weeks | Compliance to Fitbit tracking will be characterized as the time worn from appointment arrival until first void. Distribution of this variable is likely to be correlated with dwell time thus a GEE model will be used. Any patient or environmental characteristics felt to impact Fitbit tracking compliance will be included as covariates in the GEE model. |
| Fitbit and clinician obtained vitals | Up to 5 weeks | The difference between Fitbit and clinician (i.e. the bias) will be computed and compared to zero (i.e. no difference between methods). Additionally, the difference (y-axis) will be plotted as a function of clinician determined vital sign (x-axis). Bland and Altmann suggest using the gold standard (clinician determined values of vital signs) on the horizontal axis when comparing new methods to a commonly used technique. In the absence of any pattern in the plot, the 95% limits of agreement will be calculated. This interval describes the range of expected differences in 95% of patients, thus, describing the potential accuracy of the Fitbit. The mean absolute percent error for both step count and heart rate will be calculated so that the results may be compared to those reported in other medical journals. |
Countries
United States
Contacts
CONTACTThe Ohio State University Comprehensive Cancer Center
PRINCIPAL_INVESTIGATORCheryl T Lee, MD
Ohio State University Comprehensive Cancer Center
Outcome results
None listed