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Active, Not Recruiting

NCT Number: NCT05408507

Care Planning Framework in Advanced Cancer (ABC123)

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

Advanced Cancer

Age range

60 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Colorado Cancer Center

Aurora, Colorado, 80045, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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 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

Exclusion criteria

  • 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

Treatment and study plan

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.

Primary outcomes

  1. Feasibility measured through recruitment

    Time frame: 3 years

    Recruitment (proportion of those approached who actually enroll)

  2. Feasibility measured through retention in sessions

    Time frame: baseline to visit 2

    Retention number of those completing both clinic sessions

  3. Feasibility measured through retention in follow up

    Time frame: baseline to 6 month follow up

    Retention number of those completing both sessions, and follow up

Sponsors and collaborators

Lead sponsor

University of Colorado, Denver

Other

Collaborators

  • American Cancer Society, Inc.

Registry information

Official study title

Feasibility and Acceptability of the ABC123 Framework for Advanced Cancer Care

Important dates

Study start
2022
Primary completion
2026
Study completion
2027
First posted
Jun 7, 2022
Registry last updated
Feb 9, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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