Clinical trial · Interventional
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
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 12, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260912-000001
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Malignant Solid Neoplasm | Malignant Solid Neoplasm | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (6)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Best Practice | Other | — | UNRESOLVED |
| Educational Intervention | Other | — | UNRESOLVED |
| Electronic Health Record Review | Other | — | UNRESOLVED |
| Interview | Other | — | UNRESOLVED |
| Questionnaire Administration | Other | — | UNRESOLVED |
| Telephone-Based Intervention | Behavioral | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Group 1 (Usual care + A-PACT)
- description
- 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.
- interventionNames
- Other: Best Practice
- Other: Educational Intervention
- Other: Electronic Health Record Review
- Other: Interview
- Other: Questionnaire Administration
- Behavioral: Telephone-Based Intervention
- type
- ACTIVE_COMPARATOR
- label
- Group 2 (Usual care)
- description
- Patients receive usual care for 6 months.
- interventionNames
- Other: Best Practice
- Other: Electronic Health Record Review
- Other: Questionnaire Administration
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (0)
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