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Recruiting

NCT Number: NCT07048496

Intravesical Treatment of Bladder Cancer at Home, Multi-modal Treatment Support

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.

Recruiting

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Abramson Cancer Center

Philadelphia, Pennsylvania, 19104, United States

Location status: Recruiting

Location contact

Daniel J Lee, MD, MS

CONTACT

[email protected]

215-662-2891

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

BCG delivery at home

Other

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 outcomes

  1. 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

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

    Time frame: 3 months after study initiation

    The secondary outcomes will include self-efficacy and symptom management.

Study contacts

Contact information is provided by the study sponsor or research team.

Daniel Lee, PI, MD

CONTACT

[email protected]

215-615-3780

Sponsors and collaborators

Lead sponsor

Abramson Cancer Center at Penn Medicine

Other

Collaborators

  • Blue Cross Blue Shield

Registry information

Acronym: BCG at Home

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Jul 2, 2025
Registry last updated
May 13, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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