ABC123 Framework for Advanced Bladder Cancer

Overseen By Elizabeth Kessler

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Colorado, Denver

Disqualifiers: Advanced cancer, Systemic therapy, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 5

70 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new care planning method, the ABC123 framework, for individuals with advanced bladder cancer. The goal is to determine if this method, which integrates resources from geriatric care, oncology, and palliative medicine, aligns treatment planning with both patient and doctor goals. It seeks patients over 60 who have recently received a diagnosis of incurable solid-tumor cancer and are meeting with an oncologist for the first time. The trial will assess the method's ease and usefulness by following patients for six months and gathering feedback from all participants. As an unphased trial, it offers patients the chance to contribute to innovative care planning that could enhance future treatment approaches.

Do I need to stop my current medications for the trial?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial team or your doctor.

What prior data suggests that the ABC123 framework is safe for older patients with advanced cancer?

Research has shown that the ABC123 Framework offers a new approach to planning care for older patients with advanced cancer. It integrates methods from elderly care, cancer treatment, and supportive care for serious illnesses. As it is not a drug or medical procedure, it avoids the safety concerns associated with those treatments.

The focus lies on how effectively patients and doctors can use this framework to enhance care planning. Studies so far have reported no harm or negative effects from using the ABC123 Framework. It aims to align the care plan with the mutual agreement of the patient and doctor, emphasizing improved communication and care decisions rather than introducing new medical risks. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the ABC123 Framework for advanced bladder cancer because it may offer a new approach for older patients with advanced, incurable cancer. Unlike standard treatments such as chemotherapy and immunotherapy, which often come with significant side effects, the ABC123 Framework might provide a more targeted approach, potentially leading to fewer side effects. Moreover, this innovative treatment could offer hope for improved quality of life and better management of cancer symptoms in patients over 60, a group that typically faces more challenges with aggressive treatments.

What evidence suggests that the ABC123 framework is effective for advanced cancer care planning?

Research has shown that the ABC123 framework aims to improve care for older patients with advanced cancer. This framework combines methods from elderly care, cancer treatment, and palliative care, which enhances quality of life. Early findings suggest that this approach aligns the care provided with the goals of both patients and doctors. By focusing on patient-centered planning, the framework seeks to better address the needs of older adults with advanced cancer. Initial studies demonstrated that this framework improves communication and planning between patients and healthcare providers. ^{1 2 3 6 7}

Who Is on the Research Team?

Elizabeth R. Kessler

Principal Investigator

University of Colorado, Denver

Are You a Good Fit for This Trial?

This trial is for people over 60 with advanced, incurable cancer who are seeing an oncologist for the first time. They must be able to sign a consent form, follow study procedures for 6 months, and speak English. It's not open to those who've had systemic therapy for another advanced cancer or have conditions that could interfere with the study.

Inclusion Criteria

Provision to sign and date the consent form

My cancer cannot be cured with surgery or radiation and may need chemotherapy.

I am over 65, or over 60 with a health issue found in a senior's health check.

Exclusion Criteria

I have been treated with medication for another advanced cancer.

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

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Initial Care Planning

Implementation of the ABC123 framework with initial care planning, including a short physical performance battery and chemotherapy toxicity estimation

1 month

2 visits (in-person)

Follow-up

Participants complete surveys and interviews at 1, 3, and 6 months to evaluate the framework's impact and gather feedback

6 months

3 visits (in-person)

Long-term Stakeholder Feedback

Interviews with care providers and stakeholders at 1, 2, and 3 years to assess feasibility and experiences with the ABC123 framework

3 years

What Are the Treatments Tested in This Trial?

Interventions

• ABC123 Framework

Trial Overview The ABC123 framework is being tested in this pilot study. It integrates geriatric, oncology, and palliative medicine into care planning by an advanced practice provider alongside a medical oncologist. The goal is to see if it's feasible and matches patient-clinician goals.

How Is the Trial Designed?

Group I: Older patients with advanced cancer Experimental Treatment 1 Intervention

Patients over 60 years old with advanced, incurable cancer.

Who Is Running the Clinical Trial?

University of Colorado, Denver

Lead Sponsor

Trials

1,842

Recruited

3,028,000+

American Cancer Society, Inc.

Collaborator

Trials

237

Recruited

110,000+

Published Research Related to This Trial

Chemotherapy significantly improves cancer-specific mortality-free survival in patients with metastatic micropapillary carcinoma of the urinary bladder (MCUB), with a hazard ratio of 0.36, indicating a strong protective effect.

In contrast, chemotherapy showed no benefit for patients with organ-confined MCUB, and while there may be a potential protective effect in non-organ-confined stages, the study lacked sufficient statistical power to confirm this.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Micropapillary Versus Urothelial Carcinoma of the Urinary Bladder: Stage at Presentation and Efficacy of Chemotherapy Across All Stages-A SEER-based Study. Deuker, M., Stolzenbach, LF., Collà Ruvolo, C., et al.[2022]

Recent advances in genomic characterization and new therapeutic options have revitalized the treatment landscape for advanced-stage bladder cancer, which has seen little progress over the past 30 years.

The review discusses multimodal treatment strategies, including chemotherapy and innovative immunomodulatory and targeted therapies, aimed at improving outcomes for patients with locally advanced and metastatic urothelial carcinoma.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Management of Muscle-Invasive Urothelial Cancer and the Emerging Role of Immunotherapy in Advanced Urothelial Cancer. Giridhar, KV., Kohli, M.[2018]

In a study of 508 patients with stage IV bladder cancer, platinum-based chemotherapy was the most common treatment, with a median overall survival of 9.4 months from diagnosis, indicating its effectiveness in this population.

Patients who did not receive any treatment had a significantly higher risk of death (hazard ratio of 2.06), highlighting the importance of treatment in improving survival outcomes for advanced bladder cancer.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Treatment Patterns and Outcomes in Stage IV Bladder Cancer in a Community Oncology Setting: 2008-2015. Fisher, MD., Shenolikar, R., Miller, PJ., et al.[2019]

Over a 20-year period, the use of neoadjuvant chemotherapy (NAC) for patients with cT2+ bladder cancer significantly increased, peaking at 84.2% in the last year of the study, with 100% usage in eligible patients.

Patients receiving NAC showed improved survival rates, with 5-year overall survival increasing from 42.7% in the pre-NAC era to 53.2% in the NAC era, indicating that NAC is associated with better outcomes for bladder cancer patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Use of treatment pathway improves neoadjuvant chemotherapy use in muscle-invasive bladder cancer. Faraj, KS., Navaratnam, AK., Eversman, S., et al.[2021]

Cisplatin and gemcitabine are the most commonly used first-line treatment for advanced bladder cancer, showing comparable efficacy and better tolerance than the traditional four-drug regimen, especially for patients who cannot receive cisplatin due to comorbidities.

Recent advancements in molecular characterization of advanced bladder cancer have revealed actionable genetic alterations, leading to the development of targeted therapies that may significantly improve treatment outcomes by matching specific mutations with appropriate treatments.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The role of genomics in the management of advanced bladder cancer. Guancial, EA., Rosenberg, JE.[2018]

Citations

1. withpower.com withpower.com/trial/phase-urinary-bladder-neoplasms-1-2022-249a4

ABC123 Framework for Advanced Bladder Cancer This trial tests a new care planning framework called ABC123 for older patients with advanced cancer. It combines tools from elderly care, cancer treatment, ...

2. clinicaltrials.gov clinicaltrials.gov/study/NCT05408507

Care Planning Framework in Advanced Cancer (ABC123) The ABC123 care planning framework is aimed at increasing care alignment delivered to older patients with advanced cancer by combining existing tools that ...

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9058197/

Care Planning Priorities of Older Patients with Advanced ... This study highlights the perspectives of older patients and care partners on care planning and treatment of recently diagnosed advanced bladder ...

4. cancer.gov cancer.gov/research/participate/clinical-trials-search/v?id=NCI-2022-01951

Feasibility and Acceptability of the Care Planning ... This clinical trial tests the feasibility and acceptability of a care planning framework (ABC123) for patients with cancer that has spread to other places ...

5. trialfinder.panfoundation.org trialfinder.panfoundation.org/en-US/trial/listing/346475

Care Planning Framework in Advanced Cancer (ABC123) This care planning framework aims to implement existing tools in geriatric medicine, palliative medicine, and medical oncology to aid in cancer ...

6. news.cuanschutz.edu news.cuanschutz.edu/cancer-center/older-adults-with-advanced-bladder-cancer

Older Adults with Advanced Bladder Cancer Prioritize ... Results from the research are informing a pilot called ABC123: A Framework for Goal Concordant Care in Advanced Bladder Cancer, a pilot project ...

7. healio.com healio.com/news/hematology-oncology/20221006/older-patients-with-advanced-bladder-cancer-want-to-be-active-participants-in-their-care

Older patients with advanced bladder cancer 'want to be active ... Kessler: We have an ongoing pilot study using a care planning framework called ABC 123. It touches upon some of the key themes that relate to older patients ...