Engagement of Patients With Advanced Cancer
EPAC
1 other identifier
interventional
213
0 countries
N/A
Brief 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. 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Aug 2013
Longer than P75 for not_applicable
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
August 1, 2013
CompletedFirst Submitted
Initial submission to the registry
October 10, 2016
CompletedFirst Posted
Study publicly available on registry
November 17, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2016
CompletedResults Posted
Study results publicly available
December 18, 2017
CompletedOctober 31, 2018
October 1, 2018
3.3 years
October 10, 2016
January 4, 2017
October 4, 2018
Conditions
Outcome Measures
Primary Outcomes (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.
6 months after each patient enrollment
Secondary Outcomes (9)
Emergency Department Visit (Chart Review)
6 months after patient enrollment
Emergency Department Visit (Chart Review)
15 months after patient enrollment
Hospitalization Visits (Chart Review)
6 months after patient enrollment
Hospitalization Visits (Chart Review)
15 months after patient enrollment
Hospice Referral (Chart Review)
6 months after patient enrollment
- +4 more secondary outcomes
Study Arms (2)
A: Intervention Arm
EXPERIMENTALAll participants randomized to Arm A will receive the EPAC intervention as well as usual oncologic care.
B: Control Group Arm
NO INTERVENTIONAll participants randomized to Arm B will receive usual oncologic care.
Interventions
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.
Eligibility Criteria
You may qualify if:
- Newly diagnosed stage III or IV cancer
- Recurrent disease (any stage)
- Ability to consent to study
You may not qualify if:
- Patients who are unable to consent to study procedures
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Stanford Universitylead
- VA Palo Alto Health Care Systemcollaborator
Related Publications (2)
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.
PMID: 38814627DERIVEDPatel 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.
PMID: 30054634DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Dr. Manali Patel
- Organization
- Stanford University and VA Palo Alto Health Care System
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- INVESTIGATOR
- Purpose
- HEALTH SERVICES RESEARCH
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Assistant Professor
Study Record Dates
First Submitted
October 10, 2016
First Posted
November 17, 2016
Study Start
August 1, 2013
Primary Completion
December 1, 2016
Study Completion
December 1, 2016
Last Updated
October 31, 2018
Results First Posted
December 18, 2017
Record last verified: 2018-10