Feasibility and Acceptability of the ABC123 Framework for Advanced Bladder Cancer Care Planning

INTRODUCTION

  • Org Study ID: 21-5030.cc
  • Secondary ID: NCI-2022-01951, 25A9726
  • NTC ID: NCT05408507
  • Sponsor: University of Colorado, Denver

BRIEF SUMMARY

Pilot study assessing the feasibility and acceptability of the ABC123 framework, as well as goal concordance between patient and clinician stated goals. Patients >60 years old with recently diagnosed advanced, incurable bladder cancer making an initial treatment decision will be enrolled. The team will pilot test the ABC123 framework delivery by an advanced practice provider working with a medical oncologist to inform the overall care planning process. This framework will routinely incorporate and implement existing resources from these 3 transdisciplinary tenets (geriatric, oncology, palliative medicine) into initial care planning in a patient-centered manner. The team will follow patients from initial care planning to 6 months post intervention and assess additional stakeholder feedback on barriers and facilitators to implementation.

DETAILED DESCRIPTION

The ABC123 care planning framework is aimed at increasing care alignment delivered to older patients with advance bladder cancer by combining existing tools that represent the principles of geriatrics, oncology, and palliative care. In this pilot study, our primary goals are to assess the feasibility and acceptability of the ABC123 care planning framework and evaluate the framework's impact on the provision of care that aligns with the goals and values of patients. Participants will participate in a series of visits and follow-ups meant to implement and evaluate the ABC123 care planning framework that will take place over the course of six months. The first two visits will consist of 1) a short physical performance battery (SPPB) and estimation of potential for grade 3 chemotherapy toxicity using the Cancer and Aging Research Group chemotherapy toxicity calculator and 2) a guided goals of care discussion with an Advanced Practice Provider based on the findings from visit 1. During 1, 3, and 6 month follow-up sessions, participants will complete a survey consisting of several commonly used questionnaires and an interview about experiences and goals. Care providers and institutional stakeholders will also be interviewed at 1, 2, and 3 years after initial implementation to understand experiences and assess feasibility if the ABC123 framework.

  • Overall Status
    Recruiting
  • Start Date
    February 15, 2022
  • Phase
    Not Applicable
  • Study Type
    Interventional

PRIMARY OUTCOMES

Primary Outcome 1 - Measure: Feasibility measured through recruitment

Primary Outcome 1 - Timeframe: 3 years

Primary Outcome 2 - Measure: Feasibility measured through retention in sessions

Primary Outcome 2 - Timeframe: baseline to visit 2

Primary Outcome 3 - Measure: Feasibility measured through retention in follow up

Primary Outcome 3 - Timeframe: baseline to 6 month follow up

CONDITION

  • Bladder Cancer

ELIGIBILITY

Inclusion Criteria:
Provision to sign and date the consent form

- Age >65 years old, or >60 with at least one deficit on a geriatric screen.

- Stated willingness to comply with all study procedures and be available for the duration of the study

- Diagnosis of urothelial carcinoma that is not curable with surgery or radiation within the 6 mos. prior to consenting

- English speaking only for the pilot portion
Exclusion Criteria:
Have Initiated any systemic treatment for advanced urothelial carcinoma

- Have a diagnosis of another advanced cancer that has required systemic therapy.

- Have any condition that, in the opinion of the investigator, would compromise the well- being of the subject or the study or prevent the subject from meeting or performing study requirements

Gender: All

Minimum Age: 60 Years

Maximum Age: 115 Years

Healthy Volunteers: No

OFFICIAL INFORMATION

Name: Elizabeth Kessler

Role: Principal Investigator

Affiliation: University of Colorado, Denver

Overall Contact

Name: Elizabeth Kessler

Phone: 7208480170

Email: elizabeth.kessler@cuanschutz.edu

LOCATION

Facility Status Contact
Facility: University of Colorado Cancer Center
Aurora, Colorado 80045
United States
Status: Recruiting Contact: Contact
Elizabeth Kessler
720-848-0170
elizabeth.kessler@cuanschutz.edu