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CancerA-EPACNCT07690904

Algorithm-enabled Goals of Care Communication

A study of Cancer, run by VA Office of Research and Development at 1 site in United States.

Enrolling by invitation

Enrolling by invitation. The study team selects and invites participants, usually from an existing group of patients.

Sites and contacts
Official record
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Trial summary

In 2017, the VA launched the Life-Sustaining Treatment Decisions Initiative (LSTDI), a national program to promote Goals of Care communication between clinicians and patients regarding goals and preferences for care. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Cancer
Could I receive a placebo?
No, everyone receives an active treatment
How many people
200 participants
Where
1 siteUnited States
Study dates
21 Sep 2026to 30 Jun 2031
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Veteran patients with diagnosis of a solid malignancy with any cancer stage
  • English or Spanish-speaking
  • Can self-administer questionnaires in English or Spanish
  • Valid telephone number
  • Receiving oncology care at one of 7 sites
  • Receiving systemic anti-cancer therapy, defined as oral, injection, or intravenous therapy
Show all 11Show fewer
  • chemotherapy
  • hormone therapy
  • targeted therapy
  • or immunotherapy defined by the National Cancer Institute A to Z List of Cancer Drugs)
  • Care Assessment Needs (CAN) risk score ≥98th percentile (may be adjusted after examining site-level CAN performance)

Who cannot join

  • No capacity to consent
  • Actively receiving hospice care

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

United States1 site

  • VA Palo Alto Health Care System, Palo Alto, CA

    Palo Alto, California, 94304-1207

Other trials in United States

About this study

Official title: Algorithm-Enabled Engagement of Patients With Advanced Cancer (A-EPAC) to Improve Goals of Care Communication Among Veterans With Advanced Stages of Cancer

In 2017, the VA launched the Life-Sustaining Treatment Decisions Initiative (LSTDI), a national program to promote Goals of Care communication between clinicians and patients regarding goals and preferences for care. Despite clinician training and standardized Life Sustaining Treatment (LST) notes in the electronic health record (EHR), 60% of Veterans with cancer have not engaged in such communication with their oncology clinicians before death. Over the past 10 years, the team developed and tested: 1) a lay health worker-led intervention to improve these conversations and reduce unwanted, intensive end-of-life care, and 2) an algorithm-driven approach to identify patients in need of urgent conversations with their clinical teams. This randomized study will evaluate the effectiveness of an intervention combining these two approaches across 7 VA oncology sites. The outcomes include LST documentation, Veteran-reported anxiety and depression, and the identification of factors to inform broad scale of Veteran-centric interventions to improve GoC communication.

Read the detailed description

The investigators developed the Engagement of Patients with Advanced Cancer (EPAC) intervention - a 6-month telephone-based intervention in which trained lay health workers (LHWs) educate and empower Veterans with cancer to engage in goals of care conversations with their oncology clinical teams. To facilitate scale, the investigator propose Algorithm-Enabled EPAC (A-EPAC), which uses the VA Care Assessment Needs (CAN) score to automatically identify patients with cancer who could benefit from EPAC. This intent-to-treat randomized trial is conducted in collaboration with the NTO and the National VA Oncology Programs (NOP). The investigators will randomize 200 Veterans with cancer receiving care across 7 VA facilities to either the A-EPAC intervention (algorithm-based identification and referral to EPAC for 6-months) or usual cancer care alone (cancer care provided by oncology teams at the local site). Participants will be followed for 12-months post enrollment. The primary outcome is Life Sustaining Treatment documentation at 3 months post-enrollment. Secondary outcomes are patient anxiety and depression at 3 months measured by PROMIS® short forms. Exploratory outcomes include intensive end-of-life care, advance directive documentation, and acute care use. Using a quant-qual framework, the investigators will conduct validated surveys with 40 Veterans with cancer and Veteran and clinician interviews at 6 months to identify factors associated with feasibility, adoption, acceptability, and A-EPAC fidelity.

Conditions
Cancer
Being tested
Usual Care, Usual Care + Algorithm-enabled Goals of Care Communication (A-EPAC)
Keywords
Cancer
Medical subject headings
Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Usual CareBehavioural

    Also called Standard of care, standard therapy

    Usual care or standard of care as per the clinical site in which participant is receiving cancer care.

  • Usual Care + Algorithm-enabled Goals of Care Communication (A-EPAC)Behavioural

    Also called Goals of Care Behavioral Intervention

    Educational and support intervention for participants regarding goals of care discussions and engagement in these topics with a lay health worker.

Study groups in NCT07690904
Study groupRoleWhat they receive
Usual CareActive comparatorParticipants will receive usual cancer care for 12 months or until death whichever is first.
Receives: Behavioral: Usual Care
Usual Care + Algorithm-enabled Goals of Care Communication (A-EPAC)ExperimentalParticipants will be assigned to a lay health worker who will conduct education sessions over 30-45 minutes by phone initially followed by 15 minute conversations twice monthly for 6 months to discuss goals of care and how to engage in these discussions with their clinical teams. Participants will also receive usual cancer care for a total of 12 months or until death, whichever is first.
Receives: Behavioral: Usual Care; Behavioral: Usual Care + Algorithm-enabled Goals of Care Communication (A-EPAC)

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Life Sustaining Treatment Documentation

    Proportion of participants in both study groups who have a life sustaining treatment document in the electronic health record.

    Measured: 3 months

Secondary outcomes (6)

  1. Patient-reported Anxiety and Depression

    Change in mean score using the validated PROMIS Short Form v1.0 of Anxiety 4a and Depression 4a between time of enrollment and 3 months post-enrollment. Each scale consists of 4 items rated on a 5-point Likert scale. Higher scores indicate greater symptom severity. That is - higher score represents a worse outcome.

    Measured: 3 months

  2. Advance Directive Documentation

    Proportion of participants with any advance directive documentation in the electronic health record between baseline and 12 months follow-up.

    Measured: 12 months

  3. Acute Care Use

    Any hospitalization or emergency room admission within 12-months of follow-up.

    Measured: 12 months

  4. Life Sustaining Treatment Documentation

    Proportion of participants in both study groups who have a life sustaining treatment document in the electronic health record.

    Measured: 6 months

  5. Life Sustaining Treatment Documentation

    Proportion of participants in both study groups who have a life sustaining treatment document in the electronic health record.

    Measured: 9 months

  6. Life Sustaining Treatment Documentation

    Proportion of participants in both study groups who have a life sustaining treatment document in the electronic health record.

    Measured: 12 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted8 Jul 2026
  2. Study start21 Sep 2026
  3. Primary completion30 Jun 2031 (estimated)
  4. Study completion30 Jun 2031 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Health services research
Allocation
Randomised
Intervention model
Parallel groups
Model description
Parallel randomization at the participant-level
Masking
Triple blind
Who is masked
Care provider, Investigator, Outcomes assessor
Enrolment
200 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07690904
Sponsor's protocol ID
HSR6-015-24W
Other IDs
1I01RD000421-01A1
Acronym
A-EPAC
Status last verified
Oct 2026
First submitted
22 Jun 2026
Last updated
13 Oct 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study of Cancer, run by VA Office of Research and Development at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 11 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: enrolling by invitation, as of the sponsor's last update on 13 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Life Sustaining Treatment Documentation (time frame: 3 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07690904.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Oct 2026.

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