Intravesical Treatment of Bladder Cancer at Home, Multi-modal Treatment Support
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: BCG delivery at home.
- Who it may be relevant to
- Registry conditions: Bladder Cancer. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
The proposed project will have two separate cohorts. The first will be to perform a more in-depth qualitative assessment of the barriers and facilitators for treatment compliance for non-muscle invasive bladder cancer. The second arm will be to create and test a BCG at home program. Participants in the second cohort will be enrolled in a conversational agent to measure patient symptoms and quality of life and improve self-efficacy.
Detailed description
The proposed project will have two separate cohorts. The first will be to perform a more in-depth qualitative assessment of the barriers and facilitators for treatment compliance for non-muscle invasive bladder cancer. The second arm will be to create and test a BCG at home program. Participants in the second cohort will be enrolled in a conversational agent to measure patient symptoms and quality of life and improve self-efficacy.
Interventions
- Other BCG delivery at home
The BCG at home project will be a single-arm prospective pilot, to evaluate the feasibility, scalability and effectiveness of home treatment, and utilize the BB-Bot (chatbot) for PRO and adverse event measurement.
Primary outcome measures
- Rate of adherence to BCG therapy at 3 months after study initiation [Time frame: 3 months after study initiation]
Secondary outcome measures (1)
- • Self efficacy as measured by the validated General Self efficacy scale, a 10-item scale, measured at 3 months after study initiation [Time frame: 3 months after study initiation]
Eligibility criteria
Inclusion criteria
Inclusion criteria for patients in Cohort 1
- Age 18 years or older;
- completed intravesical treatment for non-muscle invasive bladder cancer within the past year Cohort 1 inclusion criteria for key stakeholders
- Age 18 years or older;
- experience with the delivery of BCG delivery for more than 2 years
Cohort 2 inclusion criteria
- Age 18 years or older;
- diagnosed with non-muscle invasive bladder cancer and prescribed BCG for initial therapy
Exclusion criteria
Cohort 1 exclusion criteria
- inability to provide informed consent
Cohort 2 exclusion criteria
- inability to provide informed consent
- inability to undergo catheterization (i.e. - history of urethral stricture)
- inability to receive BCG therapy (i.e. - previous reaction with BCG)
- no access to mobile phone
- inability to respond to written conversations in English
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
United States · 1 center
- Abramson Cancer Center — Philadelphia
Identifiers
NCT: NCT07048496 · UPCC 04823 · IRB number 23-0460