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临床试验/NCT05408507
NCT05408507进行中(未招募)不适用

Feasibility and Acceptability of the ABC123 Framework for Advanced Cancer Care

University of Colorado, Denver1 个研究点 分布在 1 个国家目标入组 70 人开始时间: 2022年2月15日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
进行中(未招募)
入组人数
70
试验地点
1
主要终点
Feasibility measured through recruitment

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Treatment
盲法
None

入排标准

年龄范围
60 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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

排除标准

  • 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

研究组 & 干预措施

Older patients with advanced cancer

Experimental

Patients over 60 years old with advanced, incurable cancer.

干预措施: ABC123 Framework (Behavioral)

结局指标

主要结局

Feasibility measured through recruitment

时间窗: 3 years

Recruitment (proportion of those approached who actually enroll)

Feasibility measured through retention in sessions

时间窗: baseline to visit 2

Retention number of those completing both clinic sessions

Feasibility measured through retention in follow up

时间窗: baseline to 6 month follow up

Retention number of those completing both sessions, and follow up

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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