NCT07278739

Testing an Educational Program to Improve Goals of Care Conversations Between Patients and Their Care Teams

A Randomized Controlled Trial of an Intervention Called "Algorithm-Enabled Patients Activated in Cancer Care Through Teams" (A-PACT) to Improve Goals of Care Communication for People With Cancer

• Status: Not Yet Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 1,020 (estimated)
• Sponsor: SWOG Cancer Research Network · Network
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

Summary

This clinical trial evaluates an educational program called Algorithm-Enabled Patients Activated in Cancer Care Through Teams (A-PACT) for reducing unplanned hospital visits and improving goals of care conversations with providers among patients with solid cancers. A-PACT is an educational program where lay health workers (educators) help patients talk with their health care team about issues that matter most to them (goals of care). During A-PACT sessions, patients receive assistance in formulating health care and end of life care preferences, assistance in completing advance directives, guidance on how to engage in these conversations with family members, friends, and clinical teams, and encouragement to discuss these topics with their clinical team. A-PACT may reduce unplanned hospital visits and improve goals of care communication with providers among patients with solid cancers.

Detailed description

PRIMARY OBJECTIVE: I. To compare the proportion of participants who have any hospitalizations within 12 months after randomization between those receiving A-PACT (intervention arm) and those receiving usual care alone (control arm). SECONDARY OBJECTIVES: I. To compare the proportion of participants who report anxiety at 3 months compared to baseline between participants receiving A-PACT and participants receiving usual care. II. To compare the proportion of participants who report depression at 3 months compared to baseline between participants receiving A-PACT and participants receiving usual care. III. To assess the proportion of participants who receive intensive end-of-life care between participants receiving A-PACT and those receiving usual care alone. IMPLEMENTATION OBJECTIVES: I. To quantitatively and qualitatively assess how patient, clinician, and organizational factors shape effectiveness and implementation of A-PACT. II. To measure feasibility of machine learning (ML) algorithm, adoption of intervention (patient enrollment), and fidelity (% of patients completing A-PACT). EXPLORATORY OBJECTIVES: I. To assess the following in participants on the intervention arm versus the usual practice arm: Ia. The proportion of participants who have any hospitalization or emergency department visits within 12 months from randomization between those receiving A-PACT and those receiving usual care; Ib. The mean number of hospitalizations within 12 months from randomization between participants receiving A-PACT and participants receiving usual care alone; Ic. The mean number of hospitalizations or emergency department visits within 12 months of randomization between participants receiving A-PACT and participants receiving usual care alone; Id. Anxiety at 6 months from baseline; Ie. Depression at 6 months from baseline; If. Heard and Understood measures at 6 months from baseline; Ig. Prognostic awareness and treatment preferences at 6 months from baseline; Ih. Presence of goals of care documentation in the electronic health record at 12 months; Ii. Presence of advance directive documentation in the electronic health record at 12 months; Ij. Presence of physician orders for life sustaining treatment documentation in the electronic health record at 12 months; Ik. The potential differential impact of sociodemographic factors on all outcomes. OUTLINE: Patients are randomized to 1 of 2 groups. GROUP 1: Patients attend an initial A-PACT education session over 30-45 minutes by phone and receive follow-up A-PACT phone calls over 15 minutes each twice monthly, or less frequently per patient preference, for up to 6 months, in addition to usual care. GROUP 2: Patients receive usual care for 6 months. After completion of study intervention, patients are followed up at months 9 and 12.

Conditions

• Malignant Solid Neoplasm

Interventions

Type	Name	Description
OTHER	Best Practice	Receive usual care
OTHER	Educational Intervention	Receive A-PACT education
OTHER	Electronic Health Record Review	Ancillary studies
OTHER	Interview	Ancillary studies
OTHER	Questionnaire Administration	Ancillary studies
BEHAVIORAL	Telephone-Based Intervention	Receive A-PACT phone calls

Timeline

• Start date: 2026-05-03
• Primary completion: 2032-01-01
• Completion: 2032-07-21
• First posted: 2025-12-12
• Last updated: 2026-04-16