What side effects are associated with this type of intervention?

Common cancer treatments such as chemotherapy and radiation therapy can have a range of side effects, particularly in older adults. Chemotherapy is associated with side effects like neutropenia, infection, dehydration, diarrhea, and fatigue. Radiation therapy can lead to pneumonitis, rash, and pruritus. Both treatments can also increase the risk of cardiac disorders and early mortality in older patients. Comprehensive geriatric assessment is crucial to determine the suitability of these treatments for older adults, balancing efficacy with the potential for severe adverse events.

What prior FDA approvals exist?

The FDA has approved several cancer treatments that align with the principles of the ABC123 Framework, focusing on geriatric, oncology, and palliative care. For instance, trastuzumab has been approved for HER2-positive metastatic breast cancer and has shown benefits in older adults, although with a higher incidence of cardiac events. Additionally, CDK 4/6 inhibitors combined with aromatase inhibitors have improved progression-free survival in both younger and older patients with hormone receptor-positive, HER2-negative breast cancer, though older adults require careful monitoring for adverse events like neutropenia and diarrhea. These treatments underscore the importance of integrating comprehensive geriatric assessments and personalized care planning to optimize outcomes in older cancer patients.

What other types of research exist?

Promising alternatives to the ABC123 Framework for cancer patients include the PalliSupport care pathway, which aims to improve care for older patients at the end of life by addressing palliative care needs and enhancing collaboration between care settings. Another alternative is the multidisciplinary team (MDT) model for interstitial lung disease (ILD) patients, which has shown effectiveness in increasing advance care planning discussions and referrals to community resources.

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ABC123 Framework for Advanced Bladder Cancer

N/A

Recruiting

Led By Elizabeth Kessler

Research Sponsored by University of Colorado, Denver

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

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

English speaking only for the pilot portion

Must not have

Have a diagnosis of a different advanced cancer that has required systemic therapy

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 3 years

Awards & highlights

No Placebo-Only Group

Summary

This trial tests a new care planning framework called ABC123 for older patients with advanced cancer. It combines tools from elderly care, cancer treatment, and comfort care to create personalized plans. The goal is to ensure that the care aligns with what patients want and need.

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

Since this trial tests a care planning framework rather than medication, traditional side effects like you'd expect from drugs aren't applicable here. However, there may be emotional or psychological impacts from discussing advanced cancer care plans.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

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

Select...

I speak English.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

Select...

I have been treated with medication for another advanced cancer.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 3 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~3 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and 3 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Feasibility measured through recruitment

Feasibility measured through retention in follow up

Denture Retention

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups

Experimental Treatment

Group I: Older patients with advanced cancerExperimental Treatment1 Intervention

Patients over 60 years old with advanced, incurable cancer.

0 / 3Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Common cancer treatments include chemotherapy, radiation therapy, and targeted therapy. Chemotherapy targets rapidly dividing cells, including cancer cells, but can also affect healthy cells, leading to side effects. Radiation therapy uses high-energy particles or waves to damage or destroy cancer cells by disrupting their DNA. Targeted therapy involves drugs that specifically target molecular markers or pathways essential for cancer cell survival and proliferation, minimizing damage to normal cells. Integrating these treatments with geriatric and palliative care principles, as in the ABC123 Framework, is crucial for older adults to tailor treatment to their overall health, manage side effects, and improve quality of life.

How to incorporate geriatric assessment in clinical decision-making for older patients with cancer. An implementation study.National consensus in China on diagnosis and treatment of patients with advanced breast cancer.