Engagement of Patients With Advanced Cancer

NCT ID: NCT02966509

Last Updated: 2018-10-31

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 213 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-08-31
• Study Completion Date: 2016-12-31

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.

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.

Conditions

End of Life; Advanced Cancer; Lung Neoplasm; Gastric Cancer; Colon Cancer; Glioblastoma Multiforme; Head and Neck Neoplasms; Rectum Cancer; Melanoma; Kidney Cancer; Prostate Cancer; Testicular Neoplasms; Liver Cancer; Cancer of Unknown Origin

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: HEALTH_SERVICES_RESEARCH
• Blinding Strategy: SINGLE

Study Groups

A: Intervention Arm

All participants randomized to Arm A will receive the EPAC intervention as well as usual oncologic care.

Group Type: EXPERIMENTAL

EPAC

Intervention Type: BEHAVIORAL

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.

B: Control Group Arm

All participants randomized to Arm B will receive usual oncologic care.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

EPAC

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.

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

• Patients who are unable to consent to study procedures

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

VA Palo Alto Health Care System

FED

Sponsor Role: collaborator

Stanford University

OTHER

Sponsor Role: lead

Responsible Party

Manali Indravadan Patel

Assistant Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

References

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.

Reference Type: DERIVED

PMID: 38814627 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 30054634 (View on PubMed)

Other Identifiers

EPAC1

Identifier Type: -

Identifier Source: org_study_id