Trial of Delivering Intravesical Therapy for Bladder Cancer in Patients’ Homes

Overview

About this study

The purpose of this study is to evaluate the feasibility and safety of in-home delivery of intravesical therapy for bladder cancer, as well as its impact on patient preference and acceptability, healthcare-related quality of life and clinical outcomes.

Participation eligibility

Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.

Inclusion Criteria

  • Female or male patients with histologically confirmed non-muscle invasive bladder cancer ( stage Ta, Tis, or T1) who are currently receiving induction therapy with one of the following eligible intravesical treatment regimens (Table 1. Eligible treatment regimens):
      • Gemcitabine;
      • Sequential gemcitabine/docetaxel;
      • Bacillus Calmette-Guerin;
      • Mitomycin C.
  • Female or male patients with histologically confirmed non-muscle invasive bladder cancer (stage Ta, Tis or T1) who are receiving maintenace thearpy with Bacillus Calmette-Guerin.
  • Residing within 35 miles of clinic (hub) or within the area serviced by supplier network.
  • Residence either has wifi or is within the cellular data network accessible by the study provided devices to enable a reliable connection with the remote command center.
  • Age ≥ 18 years at time of registration.
  • Signed Informed Consent Form by patient or the patient’s legally-authorized representative.
  • Willing and able to comply with the study protocol in the investigator’s judgment.
  • Ability to complete questionnaire(s) by themselves or with assistance.

Exclusion Criteria

  • Receiving any other investigational or standard of care agent which would be considered as a treatment for non-muscle invasive bladder cancer and is not part of the eligible treatment regimens.
  • Receiving any other treatment for cancer (except hormone therapy for breast or prostate cancer)
  • Requiring 24/7 assistance with activities of daily living (ADLs)
  • Current inpatient hospitalization (excluding admission to the Advanced Care at Home program)
  • Co-morbid systemic illnesses or other severe concurrent disease which, in the judgment of the investigator, would make the patient inappropriate for entry into this study or interfere significantly with the proper assessment of safety and toxicity of the prescribed regimens
  • Uncontrolled intercurrent illness including, but not limited to:
    • ongoing or active infection;
    • symptomatic congestive heart failure;
    • unstable angina pectoris;
    • cardiac arrhythmia;
    • myocardial infarction ≤ 6 months;
    • wound healing disorder;
    • or psychiatric illness/social situations that would limit compliance with study requirements.
  • Patients with any severe infection within 4 weeks prior to registration including, but not limited to, hospitalization for complications of infections should not be enrolled in the trial (in the current situation, this also applies to patients with suspected or confirmed COVID-19 infection)
  • Anticipation of the need for major surgery during the course of study treatment.

Note: Other protocol defined Inclusion/Exclusion Criteria may apply.

Eligibility last updated 3/8/2024. Questions regarding updates should be directed to the study team contact.

Participating Mayo Clinic locations

Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.

Mayo Clinic Location Status Contact

Jacksonville, Fla.

Mayo Clinic principal investigator

Timothy Lyon, M.D.

Contact us for the latest status

Contact information:

Cancer Center Clinical Trials Referral Office

(855) 776-0015

More information

Publications

Publications are currently not available