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

NCT ID: NCT07048496

Last Updated: 2025-08-14

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-07-05

Study Completion Date

2026-09-05

Brief Summary

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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

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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

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Bladder Cancer

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

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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.

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Age 18 years or older;
* Age 18 years or older;
* experience with the delivery of BCG delivery for more than 2 years


* Age 18 years or older;
* diagnosed with non-muscle invasive bladder cancer and prescribed BCG for initial therapy

Exclusion Criteria

• inability to provide informed consent


* 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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Pennsylvania

OTHER

Sponsor Role lead

Responsible Party

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Daniel Lee, MD, MS

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Abramson Cancer Center

Philadelphia, Pennsylvania, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Daniel Lee, PI, MD

Role: CONTACT

215-615-3780

Facility Contacts

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Daniel J Lee, MD, MS

Role: primary

215-662-2891

Other Identifiers

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UPCC 04823

Identifier Type: OTHER

Identifier Source: secondary_id

853376

Identifier Type: -

Identifier Source: org_study_id

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