Bladder CancerBCG at HomeNCT07048496
Intravesical Treatment of Bladder Cancer at Home, Multi-modal Treatment Support
A study testing BCG delivery at home in people with Bladder Cancer, run by Abramson Cancer Center at Penn Medicine at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Bladder Cancer
- What is being tested?
- BCG delivery at home
- How many people
- 50 participants
- Where
- 1 siteUnited States
- Study dates
- 5 Jul 2025to 5 Apr 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Abramson Cancer Center
Philadelphia, Pennsylvania, 19104
Daniel J Lee, MD, MS, 215-662-2891, Daniel.Lee4@pennmedicine.upenn.edu
About this study
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.
Read the 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.
- Conditions
- Bladder Cancer
- Being tested
- BCG delivery at home
- Medical subject headings
- Urinary Bladder Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BCG delivery at homeOther
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.
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 3 months after study initiation
Secondary 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.
Measured: 3 months after study initiation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jul 2025
- Study start5 Jul 2025
- Primary completion5 Feb 2027 (estimated)
- Study completion5 Apr 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bladder CancerStudies of the same condition, open and under way.
- More trials run by Abramson Cancer Center at Penn MedicineThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Abramson Cancer Center at Penn Medicine
- Sponsor type
- University, hospital or other
- Collaborators
- Blue Cross Blue Shield
- Responsible party
- Principal investigator, Daniel Lee, MD, MS, University of Pennsylvania
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07048496
- Sponsor's protocol ID
- UPCC 04823
- Other IDs
- IRB number 23-0460
- Acronym
- BCG at Home
- Status last verified
- Oct 2026
- First submitted
- 6 May 2025
- Last updated
- 5 Oct 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intravesical Treatment of Bladder Cancer at Home, Multi-modal Treatment Support
- ClinicalTrials.gov ID
- NCT07048496
- Acronym / sponsor ID
- BCG at Home / UPCC 04823
- Conditions
- Bladder Cancer
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Abramson Cancer Center at Penn MedicineUniversity, hospital or other
- Collaborators
- Blue Cross Blue Shield
- Study start
- 5 Jul 2025 (actual)
- Primary completion
- 5 Feb 2027 (estimated)
- Study completion
- 5 Apr 2027 (estimated)
- First posted
- 2 Jul 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (8 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| BCG delivery at homeThe 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. | Other | – |
Primary outcome
Rate of adherence to BCG therapy at 3 months after study initiation
Time frame: 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
1 secondary outcome
• 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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Oct 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing BCG delivery at home in people with Bladder Cancer, run by Abramson Cancer Center at Penn Medicine at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 5 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Daniel Lee, PI, MD (215-615-3780, daniel.lee4@pennmedicine.upenn.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rate of adherence to BCG therapy at 3 months after study initiation (time frame: 3 months after study initiation). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Oct 2026.