Intravesical Treatment of Bladder Cancer at Home, Multi-modal Treatment Support
ConditionBladder Cancer
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorAbramson Cancer Center at Penn Medicine
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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
Trial design
Design model
Single group
Treatments tested in this trial
BCG delivery at home
Other interventionThe 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.
Treatment groups
No treatment groups listed
Trial outcomes
Primary outcomes
1
Rate of adherence to BCG therapy at 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
Time frame
3 months after study initiationSecondary outcomes
1
• Self efficacy as measured by the validated General Self efficacy scale, a 10-item scale, measured at 3 months after study initiation
The secondary outcomes will include self-efficacy and symptom management.
Time frame
3 months after study initiationSponsors and contacts
Click on the lead sponsor to view all of their trials.
Abramson Cancer Center at Penn Medicine
Lead sponsor
University of Pennsylvania
Sponsor institution
Blue Cross Blue Shield
Collaborator
Source ClinicalTrials.gov