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

NCT07278739 | Not Yet Recruiting DMC

• 5 other identifiers: S2424CDNCI-2025-08258SWOG-S2424CDR37CA296075UG1CA189974
• Study Type: interventional
• Target: 1,020
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Malignant Solid Neoplasm

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (6)

• Proportion of patients with 0 versus >= 1 of the combined endpoint of hospitalizations or emergency room (ER) visits

  Up to 12 months

• Number of hospitalizations as a continuous outcome

  Up to 12 months

• Number of hospitalizations or ER visits

  Up to 12 months

• Intensive end-of-life care

  Up to 12 months

• Anxiety

  At 3 months after enrollment

Other Outcomes (15)

• Goals of care communication

  Up to 12 months

• Emergency room visits

  Up to 12 months

• Patient-reported anxiety

  At baseline, 3 months, and 6 months

Study Arms (2)

Group 1 (Usual care + A-PACT)

EXPERIMENTAL

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: Best Practice; Other: Educational Intervention; Other: Electronic Health Record Review; Other: Interview; Other: Questionnaire Administration; Behavioral: Telephone-Based Intervention

Group 2 (Usual care)

ACTIVE COMPARATOR

Patients receive usual care for 6 months.

Other: Best Practice; Other: Electronic Health Record Review; Other: Questionnaire Administration

Interventions

Educational Intervention OTHER

Receive A-PACT education

Also known as: Education for Intervention, Intervention by Education, Intervention through Education, Intervention, Educational

Group 1 (Usual care + A-PACT)

Interview OTHER

Ancillary studies

Group 1 (Usual care + A-PACT)

Questionnaire Administration OTHER

Ancillary studies

Group 1 (Usual care + A-PACT); Group 2 (Usual care)

Telephone-Based Intervention BEHAVIORAL

Receive A-PACT phone calls

Group 1 (Usual care + A-PACT)

Best Practice OTHER

Receive usual care

Also known as: standard of care, standard therapy

Group 1 (Usual care + A-PACT); Group 2 (Usual care)

Electronic Health Record Review OTHER

Ancillary studies

Group 1 (Usual care + A-PACT); Group 2 (Usual care)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

Sponsors & Collaborators

• SWOG Cancer Research Network: lead
• National Cancer Institute (NCI): collaborator

MeSH Terms

Interventions

Practice Guidelines as Topic; Standard of Care; Early Intervention, Educational; Educational Status; Methods; Interviews as Topic

Intervention Hierarchy (Ancestors)

Guidelines as Topic; Quality Assurance, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation; Quality Indicators, Health Care; Child Health Services; Community Health Services; Health Services; Health Care Facilities Workforce and Services; Preventive Health Services; Socioeconomic Factors; Population Characteristics; Investigative Techniques; Data Collection; Epidemiologic Methods; Health Care Evaluation Mechanisms; Public Health; Environment and Public Health

Study Officials

• Ravi B Parikh

  SWOG Cancer Research Network

  PRINCIPAL INVESTIGATOR

• Manali Patel, MPH MS FASCO

  Stanford School of Medicine

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Patricia O'Kane

CONTACT

2106148808; pokane@swog.org

Sarah Cantu

CONTACT

2106148808; scantu@swog.org

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: CARE PROVIDER
• Masking Details: Randomization assignment is not revealed to clinicians and general staff.
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: NETWORK
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 5, 2025
• First Posted: December 12, 2025
• Study Start: May 3, 2026
• Primary Completion (Estimated): January 1, 2032
• Study Completion (Estimated): July 21, 2032
• Last Updated: April 16, 2026

Record last verified: 2026-04