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End of LifeEPACNCT02966509

Engagement of Patients With Advanced Cancer

A study testing EPAC in people with End of Life and Advanced Cancer, run by Stanford University.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The Engagement of Patients with Advanced Cancer is an intervention that utilizes well-trained lay health coaches to engage patients and their families in goals of care and shared decision-making after a diagnosis of advanced cancer. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
End of Life, Advanced Cancer, Lung Neoplasm
What is being tested?
EPAC
Could I receive a placebo?
No, everyone receives an active treatment
How many people
213 participants
Where
No sites listed yet
Study dates
Aug 2013to Dec 2016
Phase
Interventional
Are there results?
Yes, posted in the registrySummary in the doctors' view

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

  • Newly diagnosed stage III or IV cancer
  • Recurrent disease (any stage)
  • Ability to consent to study

Who cannot join

  • Patients who are unable to consent to study procedures

About this study

The Engagement of Patients with Advanced Cancer is an intervention that utilizes well-trained lay health coaches to engage patients and their families in goals of care and shared decision-making after a diagnosis of advanced cancer. Although lay health workers have never been tested in this role, we hypothesize that lay health workers can feasibly improve goals of care documentation and help to reduce unwanted healthcare utilization at the end of life for Veterans diagnosed with new advanced stages of cancer and those diagnosed with recurrent disease.

Read the detailed description

VAPAHCS proposes to implement and evaluate several critical elements to be in alignment with the VHA's Strategic Goal and priority areas for FY2013. The Engagement of Patients with Advanced Cancer project is an innovative program that will strengthen provider-patient relationship and facilitate whole person care about matters important to Veterans with cancer and important to support network and family. The project is intended to help establish Goals of Care Plan with appropriate documentation, develop, deploy, and evaluate a model of care for persons with cancer that is intended to improve clinical outcomes and experience of care for individuals with advanced cancer who have advanced cancer (stages III, IV or recurrent disease). The intervention provides patients with lay health coaches who assist patients and their families in discussing goals of care and engage in shared-decision making. The goal of the project is to demonstrate that there is improved patient experiences, outcomes, and that the program helps to reduce utilization of health care resources at the end of life.

Being tested
EPAC
Medical subject headings
Death, Lung Neoplasms, Stomach Neoplasms, Colonic Neoplasms, Glioblastoma, Head and Neck Neoplasms, Rectal Neoplasms, Melanoma

What participants receive

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

  • EPACBehavioural

    Each patient will receive a lay health worker who will engage and educate patients on goals of care documentation and will continue to address goals of care for at least 6 months with patients after enrollment in the study.

Study groups in NCT02966509
Study groupRoleWhat they receive
A: Intervention ArmExperimentalAll participants randomized to Arm A will receive the EPAC intervention as well as usual oncologic care.
Receives: Behavioral: EPAC
B: Control Group ArmNo interventionAll participants randomized to Arm B will receive usual oncologic care.

What is being measured

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

  1. Number of Participants With Completed Goals of Care Documentation. We Will Evaluate if 75% of Patients in the Intervention Arm Have a Documented Goals of Care Titled Medical Note Within 6 Months of Patient Enrollment in the Study.

    Feasibility is defined as at least 75% of patients in the intervention arm with a documented Goals of Care titled medical note within 6 months of patient enrollment in the study.

    Measured: 6 months after each patient enrollment

Secondary outcomes (9)

  1. Emergency Department Visit (Chart Review)

    Emergency Department Use for each patient will be abstracted by electronic medical record chart review for each patient at 6 months after enrollment.

    Measured: 6 months after patient enrollment

  2. Emergency Department Visit (Chart Review)

    Emergency Department Use for each patient will be abstracted by electronic medical record chart review for each patient at 15 months after enrollment.

    Measured: 15 months after patient enrollment

  3. Hospitalization Visits (Chart Review)

    Hospitalization use for each patient will be abstracted by electronic medical record chart review for each patient at 6 months after enrollment.

    Measured: 6 months after patient enrollment

  4. Hospitalization Visits (Chart Review)

    Hospitalization use for each patient will be abstracted by electronic medical record chart review for each patient at 15 months after enrollment.

    Measured: 15 months after patient enrollment

  5. Hospice Referral (Chart Review)

    Hospice referral for each patient will be abstracted by electronic medical record chart review for each patient at 6 months after enrollment.

    Measured: 6 months after patient enrollment

  6. Palliative Care Referral (Chart Review)

    Palliative Care Referral for each patient will be abstracted by electronic medical record chart review for each patient at 6 months after enrollment.

    Measured: 6 months after patient enrollment

  7. Palliative Care Referral (Chart Review)

    Palliative Care Referral for each patient will be abstracted by electronic medical record chart review for each patient at 15 months after enrollment.

    Measured: 15 months after patient enrollment

  8. Change in Patient Satisfaction With Care Using the Consumer Assessment of Health Care Providers and Systems -General Survey

    Each patient will receive a satisfaction with care survey (The Consumer Assessment of Health Care Providers and Systems - General (CAHPS)) at baseline and 6 months. We will measure the change in satisfaction from baseline to 6 months. Scores for satisfaction were assessed using the Consumer Assessment of Healthcare Providers and Systems-General survey question #18 which measured rating of health provider, on which scores range from 0 to 10, with higher ratings correspond to higher patient satisfaction. Scores for each group are averaged at baseline and at 6 months.

    Measured: Change in Patient Satisfaction with Care from baseline to 6 months.

  9. Patient Satisfaction With Decision-Making Using the Satisfaction With Decision Survey

    Each patient will receive a validated satisfaction with decision-making survey (The Satisfaction with Decision Survey) at 6 months after study enrollment.Satisfaction with Decision was assessed with the use of the 6-question Satisfaction with Decision Scale, on which scores range from 0 to 5, with higher scores indicating better satisfaction with decision-making. Scores for each group are averaged at 6 months after study enrollment.

    Measured: 6 months

Timeline

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

  1. First posted17 Nov 2016 (estimated)
  2. Study startAug 2013
  3. Primary completionDec 2016
  4. Study completionDec 2016

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
Masking
Single blind
Who is masked
Investigator
Enrolment
213 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02966509
Sponsor's protocol ID
EPAC1
Acronym
EPAC
Status last verified
Oct 2018
First submitted
10 Oct 2016
Last updated
31 Oct 2018
Data monitoring committee
No

Publications

  • Patel MI, Agrawal M, Blayney DW, Bundorf MK, Milstein A. Long-Term Engagement of Patients With Advanced Cancer: Results From the EPAC Randomized Clinical Trial. JAMA Oncol. 2024 Jul 1;10(7):905-911. doi: 10.1001/jamaoncol.2024.1221.

    PubMed 38814627

  • Patel MI, Sundaram V, Desai M, Periyakoil VS, Kahn JS, Bhattacharya J, Asch SM, Milstein A, Bundorf MK. Effect of a Lay Health Worker Intervention on Goals-of-Care Documentation and on Health Care Use, Costs, and Satisfaction Among Patients With Cancer: A Randomized Clinical Trial. JAMA Oncol. 2018 Oct 1;4(10):1359-1366. doi: 10.1001/jamaoncol.2018.2446.

    PubMed 30054634

Questions about this trial

What is this clinical trial studying?

A study testing EPAC in people with End of Life and Advanced Cancer, run by Stanford University.

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 3 inclusion and 1 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: finished, as of the sponsor's last update on 31 Oct 2018. Status can change between updates, so confirm with the study contact before making plans.

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?

Yes. Results are posted in the registry (first posted 18 Dec 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Number of Participants With Completed Goals of Care Documentation. We Will Evaluate if 75% of Patients in the Intervention Arm Have a Documented Goals of Care Titled Medical Note Within 6 Months of Patient Enrollment in the Study. (time frame: 6 months after each patient enrollment). 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 NCT02966509, which also lists 2 linked publications.

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 31 Oct 2018.

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