Recruiting

A-PACT

Sponsor:

SWOG Cancer Research Network

Code:

NCT07278739

Conditions

Malignant Solid Neoplasm

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Accepted

Interventions

Best Practice

Educational Intervention

Electronic Health Record Review

Interview

Questionnaire Administration

Study Details

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

Study ID

NCT07278739

Start date

Sep 3, 2026

Status verified date

Aug, 2026

Completion date

Jul 21, 2032

Anticipated

Primary completion date

Jan 1, 2032

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Accepted

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 Design

Enrollment

1020 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Health Services Research

Interventions and Outcome Measures

Arms

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.

active comparator: Group 2 (Usual care)

Patients receive usual care for 6 months.

Interventions

Best Practice

Receive usual care

Educational Intervention

Receive A-PACT education

Electronic Health Record Review

Ancillary studies

Interview

Ancillary studies

Questionnaire Administration

Ancillary studies

Telephone-Based Intervention

Receive A-PACT phone calls

Primary outcome measure

  • Proportion of patients with any hospitalization [ Time Frame: Within 12 months of enrollment ]

Central Contacts and Locations

Central contacts

Patricia O'Kane

2106148808pokane@swog.org

Sarah Cantu

2106148808scantu@swog.org

Locations

CARTI Cancer Center

Recruiting

Little Rock, Arkansas, United States, 72205

Contacts

Site Public Contact

501-906-4199Research@CARTI.com

Principal Investigator:

Jay W. Carlson

More Information

Sponsor

SWOG Cancer Research Network

Last update posted

Aug 5, 2026

Last verified

Aug, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by SWOG Cancer Research Network on 2026-08-05.