This phase Ib/II trial compares the safety, tolerability and acceptability of intravesical chemotherapy given at home to in-clinic administration in patients with non-muscle invasive bladder cancer. Chemotherapy drugs, such as bacillus Calmette-Guerin (BCG), gemcitabine, docetaxel, and mitomycin C, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Standard of care chemotherapy for non-invasive bladder cancer is usually given directly into the bladder through a catheter (intravesical). This process requires numerous visits and can be disruptive to the lives of patients and caregivers. Bringing cancer care to the patients with in-home intravesical therapy may help reduce the disruption to daily lives. In-home intravesical chemotherapy may be safe and tolerable and may also be preferable to in-clinic administration in patients with non-muscle invasive bladder cancer.
PHASE IB AND PHASE II: Female or male patients with histologically confirmed non-muscle invasive bladder cancer (stage Ta, Tis, or T1) who are currently receiving induction therapy with one of the following eligible intravesical treatment regimens
Gemcitabine
Sequential gemcitabine/docetaxel
Bacillus Calmette-Guerin
Receiving any other investigational or standard of care agent which would be considered as a treatment for non-muscle invasive bladder cancer and is not part of the eligible treatment regimens
Actively receiving any other treatment for cancer (except hormone therapy for breast or prostate cancer, or treatment for non-invasive skin cancer)
Requiring 24/7 assistance with activities of daily living (ADLs)
Current inpatient hospitalization (excluding admission to the Advanced Care at Home program)
Single group
BCG Solution
Biological/VaccineGiven intravesically
Cystoscopy
Procedure/SurgeryUndergo cystoscopy
Docetaxel
DrugGiven intravesically
Gemcitabine
DrugGiven intravesically
Home Health Encounter
Other interventionReceive access to CCBW home health visits
Mitomycin
DrugGiven intravesically
Questionnaire Administration
Other interventionAncillary studies
Incidence and severity of adverse events (AEs)
The incidence, type, and severity of AEs experienced will be reported. The maximum grade for each type of AE will be summarized using Common Terminology Criteria for Adverse Events (CTCAE) version 5.0.
Feasibility of in-home intravesical therapy
Feasibility will be indicated by the proportion of patients who receive at least 4 of 5 planned doses of induction therapy in the home within 12 weeks of the first dose of intravesical therapy (received in the outpatient clinic).
Patient-preferred treatment location
The frequency and proportion of patients who indicate a preference for in-home intravesical therapy versus a traditional setting will be assessed using the Patient Satisfaction and Feedback Questionnaire. The questionnaire consists of 4 questions related to receipt of care \[answered on a 5-point scale (e.g., Excellent/Very Good/Good/Fair/Poor or Very Effective/Capable and Effective/Neutral/Somewhat Effective/Needs Development)\]; 1 question related to preference for treatment location; 3 questions answered with yes, no, or uncertain; 1 question related to experience (better than expected, same as expected, worse than expected); and 1 opened ended for feedback as to what could have improved the experience.
Patient-reported likelihood to recommend at home therapy
Will be assessed using the Patient Satisfaction and Feedback Questionnaire. The frequency and proportion of patients who would recommend in-home intravesical therapy to other patients will be reported. The questionnaire consists of 4 questions related to receipt of care \[answered on a 5-point scale (e.g., Excellent/Very Good/Good/Fair/Poor or Very Effective/Capable and Effective/Neutral/Somewhat Effective/Needs Development)\]; 1 question related to preference for treatment location; 3 questions related to acceptability and likely recommendation answered with yes, no, or uncertain; 1 question related to experience (better than expected, same as expected, worse than expected); and 1 opened ended for feedback as to what could have improved the experience.
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Mayo Clinic
Lead sponsor
National Center for Advancing Translational Sciences (NCATS)
Collaborator
