Care Planning Framework in Advanced Cancer (ABC123)

NCT05408507 | Active Not Recruiting DMC

• 3 other identifiers: 21-5030.ccNCI-2022-0195125A9726
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 1

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 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.

Conditions

Advanced Cancer

Keywords

incurable cancer; geriatric oncology; goals of care

Outcome Measures

Primary Outcomes (3)

• Feasibility measured through recruitment

  Recruitment (proportion of those approached who actually enroll)

  3 years

• Feasibility measured through retention in sessions

  Retention number of those completing both clinic sessions

  baseline to visit 2

• Feasibility measured through retention in follow up

  Retention number of those completing both sessions, and follow up

  baseline to 6 month follow up

Study Arms (1)

Older patients with advanced cancer

EXPERIMENTAL

Patients over 60 years old with advanced, incurable cancer.

Behavioral: ABC123 Framework

Interventions

ABC123 Framework BEHAVIORAL

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.

Older patients with advanced cancer

Eligibility Criteria

• Age: 60 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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 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.
• New patient consultation within the UCHealth Denver Metro system or newly diagnosed with recurrent metastatic/incurable disease
• English speaking only for the pilot portion

You may not qualify if:

• Have a diagnosis of a different 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

Sponsors & Collaborators

• University of Colorado, Denver: lead
• American Cancer Society, Inc.: collaborator

Study Sites (1)

University of Colorado Cancer Center

Aurora, Colorado, 80045, United States

Location

Study Officials

• Elizabeth Kessler

  University of Colorado, Denver

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 17, 2022
• First Posted: June 7, 2022
• Study Start: February 15, 2022
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 1, 2027
• Last Updated: February 9, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)