An Assessment of Patient Position and Intravesical BCG Dwell Time
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Bacillus Calmette Guerin (BCG) dwell time
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
Treatment (BCG no restrictions, BCG lying down, BCG sitting)
Patients receive SOC BCG therapy 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.
干预措施: Accelerometry (Procedure)
Treatment (BCG no restrictions, BCG lying down, BCG sitting)
Patients receive SOC BCG therapy 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.
干预措施: BCG Solution (Biological)
Treatment (BCG no restrictions, BCG lying down, BCG sitting)
Patients receive SOC BCG therapy 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.
干预措施: Electronic Health Record Review (Other)
Treatment (BCG no restrictions, BCG lying down, BCG sitting)
Patients receive SOC BCG therapy 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.
干预措施: Patient Discharge (Behavioral)
Treatment (BCG no restrictions, BCG lying down, BCG sitting)
Patients receive SOC BCG therapy 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.
干预措施: Survey Administration (Other)
结局指标
主要结局
Bacillus Calmette Guerin (BCG) dwell time
时间窗: 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.
次要结局
- Probability of maintaining BCG for at least 1 hour(From the instillation of the drug up to 1 hour, assessed up to 5 weeks)
- Compliance with study instructions(Up to 5 weeks)
- Compliance to Fitbit tracking(From appointment arrival until first void, assessed up to 5 weeks)
- Fitbit and clinician obtained vitals(Up to 5 weeks)
研究者
Cheryl Lee
Principal Investigator
Ohio State University Comprehensive Cancer Center