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Active, not recruitingNCT05408507Updated Feb 9, 2026

Care Planning Framework in Advanced Cancer (ABC123)

An interventional study of ABC123 Framework in Advanced Cancer, sponsored by University of Colorado, Denver. Active, not recruiting at 1 site in United States. Open to participants aged 60 Years and older. Per ClinicalTrials.gov, last updated 2026-02-09.

Sponsored by University of Colorado, Denver · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Registered 3 months after the study started (first participant enrolled Feb 2022, registered May 2022).
Phase
Not applicable
Study type
Interventional
Enrollment
70
Allocation
Not applicable
Ages
60 Years and older
Sex
All
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Study 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 cancer in for a first consultation at a participating medical oncology clinic. 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, and 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.

Read the detailed description

The ABC123 care planning framework is aimed at increasing care alignment delivered to older patients with advanced 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) 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 the feasibility if the ABC123 framework.

02

Conditions studied

  • Advanced Cancer

Keywords

  • incurable cancer
  • geriatric oncology
  • goals of care
03

In context

Lead sponsor

University of Colorado, Denver is the lead sponsor of 1,499 studies on the registry; 315 are open to participants now.

Of its 139 completed or terminated interventional studies of FDA-regulated products, 89 (64%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
60 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  1. Provision to sign and date the consent form
  2. Age >65 years old, or >60 with at least one deficit on a geriatric screen.
  3. Stated willingness to comply with all study procedures and be available for the duration of the study
  4. Diagnosis of a solid-tumor cancer that is not curable with surgery or radiation within the 6 mos. prior to consenting. And that would potentially be treated with systemic cytotoxic chemotherapy. If molecular marker status is pending for a particular tumor, patients may still be approached for enrollment in the study.
  5. New patient consultation within the UCHealth Denver Metro system or newly diagnosed with recurrent metastatic/incurable disease
  6. English speaking only for the pilot portion

Exclusion criteria

Exclusion Criteria:

  1. Have a diagnosis of a different advanced cancer that has required systemic therapy
  2. 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
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
70 participants (estimated)

Study arms

  • Experimental
    Older patients with advanced cancer

    Patients over 60 years old with advanced, incurable cancer.

    Behavioral: ABC123 Framework

Interventions

  • BehavioralABC123 Framework

    This care planning framework aims to implement existing tools in geriatric medicine, palliative medicine, and medical oncology to aid in cancer care planning for older adults with newly diagnosed incurable advanced cancer and to test the delivery of goal-concordant care. This patient-centered intervention is the ABC123 care planning framework in parallel with usual care that includes a physical function assessment, chemotherapy toxicity estimate calculation, and a guided goals of care discussion.

06

What researchers measure

Primary outcomes

  1. Feasibility measured through recruitment

    Recruitment (proportion of those approached who actually enroll)

    Time frame: 3 years

  2. Feasibility measured through retention in sessions

    Retention number of those completing both clinic sessions

    Time frame: baseline to visit 2

  3. Feasibility measured through retention in follow up

    Retention number of those completing both sessions, and follow up

    Time frame: baseline to 6 month follow up

07

Study locations

1 site
  • University of Colorado Cancer Center
    Aurora, Colorado 80045, United States
08

References and documents

Publications

  • Kessler ER, Min SJ, Hoover K, Coats H, Fischer SM. Feasibility and Acceptability of the ABC123 Framework for Advanced Cancer Care: Study Protocol. Nurs Res. 2026 May-Jun 01;75(3):241-245. doi: 10.1097/NNR.0000000000000888. Epub 2026 Feb 3. PubMed 41630360 ↗

Individual participant data

Plan to share: No

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 9, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT05408507
Lead sponsor
University of Colorado, Denver
Collaborators
American Cancer Society, Inc.
Responsible party
Sponsor
First posted
Jun 7, 2022
Start date
Feb 15, 2022
Primary completion
Dec 31, 2026 (estimated)
Completion
Dec 2027 (estimated)
Last update
Feb 9, 2026

Study contacts

Elizabeth Kessler
principal investigator · University of Colorado, Denver

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is active, not recruiting, as verified in Feb 2026. You cannot join it, but the record below documents what was studied.

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