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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Malignant Solid Neoplasm
• Intervention / Treatment: Other: Questionnaire Administration; Other: Best Practice; Other: Interview; Other: Electronic Health Record Review; Other: Educational Intervention; Behavioral: Telephone-Based Intervention

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.

• Study Type: Interventional
• Enrollment (Estimated): 1020
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Patricia O'Kane; Phone Number: 1011 2106148808; Email: pokane@swog.org
• Study Contact Backup: Name: Sarah Cantu; Phone Number: 2106148808; Email: scantu@swog.org

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• Participants must have a diagnosis of a solid tumor malignancy of any stage
• Participants must be identified as high risk, defined as having 6 month mortality estimate from machine learning (ML) algorithm >= 20%
• Participants must not be receiving or have pre-existing plans to enter hospice care at the time of study registration

• Participant must be actively receiving or planning to receive systemic anti-cancer therapy (defined as any oral, injection, or intravenous therapy against cancer) within 3 months after registration

  • NOTE: This includes chemotherapy (conventional or cytotoxic chemotherapy), hormone therapy, targeted therapy, and immunotherapy
  • NOTE: Participants are allowed to be co-enrolled on other clinical trials including trials using investigational agents
• Participants must be >= 18 years of age at the time of study enrollment
• Participants who can complete Patient Reported Outcome (PRO) questionnaires in English or Spanish must be willing to 1) complete PROs at all scheduled assessments; and 2) complete the pre-registration (baseline) PRO forms within 14 days prior to registration
• Participants must be able to provide a valid telephone number for the purpose of being contacted by the lay health worker

• NOTE: As a part of the Oncology Patient Enrollment Network (OPEN) registration process the treating institution's identity is provided in order to ensure that the current (within 365 days) date of institutional review board approval for this study has been entered in the system

  • Patient and clinician participants must be informed of the investigational nature of this study and must sign and give informed consent in accordance with institutional and federal guidelines. This protocol does not permit use of Legally Authorized Representative NOTE: For this study, in the OPEN registration, clinician participants will be listed as their own treating investigator. However, clinician participants must not consent themselves or sign their own eligibility criteria forms

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Group 1 (Usual care + A-PACT); 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.	Other: Questionnaire Administration; Ancillary studies; Other: Best Practice; Receive usual care; Other Names: standard of care; standard therapy; Other: Interview; Ancillary studies; Other: Electronic Health Record Review; Ancillary studies; Other: Educational Intervention; Receive A-PACT education; Other Names: Education for Intervention; Intervention by Education; Intervention through Education; Intervention, Educational; Behavioral: Telephone-Based Intervention; Receive A-PACT phone calls
Active Comparator: Group 2 (Usual care); Patients receive usual care for 6 months.	Other: Questionnaire Administration; Ancillary studies; Other: Best Practice; Receive usual care; Other Names: standard of care; standard therapy; Other: Electronic Health Record Review; Ancillary studies

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Proportion of patients with any hospitalization	The primary analysis will be conducted using multivariable logistic regression, adjusting for stratification factors as covariates.	Within 12 months of enrollment

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Proportion of patients with 0 versus >= 1 of the combined endpoint of hospitalizations or emergency room (ER) visits	Logistic, linear, and negative binomial regression models will be used, as appropriate for the given endpoint. Each regression analysis will include covariate adjustment for the stratification variables.	Up to 12 months
Number of hospitalizations as a continuous outcome	Logistic, linear, and negative binomial regression models will be used, as appropriate for the given endpoint. Each regression analysis will include covariate adjustment for the stratification variables.	Up to 12 months
Number of hospitalizations or ER visits	Logistic, linear, and negative binomial regression models will be used, as appropriate for the given endpoint. Each regression analysis will include covariate adjustment for the stratification variables.	Up to 12 months
Intensive end-of-life care	Logistic, linear, and negative binomial regression models will be used, as appropriate for the given endpoint. Each regression analysis will include covariate adjustment for the stratification variables.	Up to 12 months
Anxiety	Logistic, linear, and negative binomial regression models will be used, as appropriate for the given endpoint. Each regression analysis will include covariate adjustment for the stratification variables. Baseline score will also be included as a model covariate.	At 3 months after enrollment
Depression	Logistic, linear, and negative binomial regression models will be used, as appropriate for the given endpoint. Each regression analysis will include covariate adjustment for the stratification variables. Baseline score will also be included as a model covariate.	At 3 months after enrollment

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Goals of care communication	Abstracted from the electronic health record. Will assess differential impact by income and race and ethnicity.	Up to 12 months
Emergency room visits	Will assess differential impact by income and race and ethnicity.	Up to 12 months
Patient-reported anxiety	Measured using Patient Reported Outcomes Measurement Information System (PROMIS) version 1.0 Short Form Anxiety. Will assess differential impact by income and race and ethnicity.	At baseline, 3 months, and 6 months
Patient-reported depression	Measured using PROMIS version 1.0 Short Form Depression. Will assess differential impact by income and race and ethnicity.	At baseline, 3 months, and 6 months
Patient-reported quality of communication with clinical staff	Assessed using the Heard and Understood questionnaire. Will assess differential impact by income and race and ethnicity.	At baseline, 3 months, and 6 months
Patient-reported experiences with end of life care discussions	Will be measured using the Prognostic Awareness and Treatment Preferences instrument. Will assess differential impact by income and race and ethnicity.	At baseline, 3 months, and 6 months
Hospitalizations alone	Will be evaluated as time-to-event analysis. Will assess differential impact by income and race and ethnicity.	Up to 12 months
Hospitalizations and ER visits	Will be evaluated as time-to-event analysis. Will assess differential impact by income and race and ethnicity.	Up to 12 months
ER visits	Will be evaluated as time-to-event analysis. Will assess differential impact by income and race and ethnicity.	Up to 12 months
Percentage of approached sites that can map the electronic health record query (Feasibility)	Feasibility goal for this implementation outcome is >= 90%.	Up to 6 years
Percentage of sites that can run the machine learning (ML) algorithm Python code on site (Feasibility)	Feasibility goal for this implementation outcome is >= 90%.	Up to 6 years
Percentage of sites where ML retraining is not necessary prior to trial activation (Feasibility)	Feasibility goal for this implementation outcome is >= 50%.	Up to 6 years
Percentage of eligible patients who consent to study (Adoption)	Adoption goal for this implementation outcome is >= 50%.	Up to 6 years
Percentage of patients enrolled in the intervention arm who engage with the lay health workers at least once a month for first 6 months, prior to death, or prior to transition to hospice (Fidelity)		Up to 6 years
Acceptability of intervention	Assessed during mixed-methods interviews among intervention participants.	At 6 months after trial enrollment

Collaborators and Investigators

• Sponsor: SWOG Cancer Research Network
• Collaborators: National Cancer Institute (NCI)
• Investigators: Principal Investigator: Ravi B Parikh, SWOG Cancer Research Network; Principal Investigator: Manali Patel, MPH MS FASCO, Stanford School of Medicine

Study record dates

Study Major Dates

• Study Start (Estimated): May 3, 2026
• Primary Completion (Estimated): January 1, 2032
• Study Completion (Estimated): July 21, 2032

Study Registration Dates

• First Submitted: December 5, 2025
• First Submitted That Met QC Criteria: December 5, 2025
• First Posted (Actual): December 12, 2025

Study Record Updates

• Last Update Posted (Actual): April 16, 2026
• Last Update Submitted That Met QC Criteria: April 13, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Health Services Administration; Health Care Quality, Access, and Evaluation; Investigative Techniques; Epidemiologic Methods; Data Collection; Health Care Evaluation Mechanisms; Quality of Health Care; Public Health; Environment and Public Health; Quality Indicators, Health Care; Health Services; Health Care Facilities Workforce and Services; Child Health Services; Community Health Services; Preventive Health Services; Socioeconomic Factors; Population Characteristics; Guidelines as Topic; Quality Assurance, Health Care; Methods; Interviews as Topic; Standard of Care; Early Intervention, Educational; Educational Status; Practice Guidelines as Topic
• Other Study ID Numbers: S2424CD (Other Identifier: CTEP); UG1CA189974 (U.S. NIH Grant/Contract); NCI-2025-08258 (Registry Identifier: CTRP (Clinical Trial Reporting Program)); SWOG-S2424CD (Other Identifier: DCP); R37CA296075 (U.S. NIH Grant/Contract)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No