Bladder Cancer
Conditions
Brief summary
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
OTHERBCG 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.
Sponsors
Abramson Cancer Center at Penn Medicine
Blue Cross Blue Shield
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
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Rate of adherence to BCG therapy at 3 months after study initiation | 3 months after study initiation | The primary outcome will be the rate of adherence to AUA guidelines for BCG therapy as measured by successful treatments of BCG compared to expected treatments. For each participant, adherence will be calculated both as the percentage of adherent doses, evaluable for study participants |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| • Self efficacy as measured by the validated General Self efficacy scale, a 10-item scale, measured at 3 months after study initiation | 3 months after study initiation | The secondary outcomes will include self-efficacy and symptom management. |
Countries
United States
Contacts
CONTACTDaniel Lee, PI, MD
Outcome results
None listed