Patient-centered and Efficacious Advance Care Planning in Cancer: the PEACe Comparative Effectiveness Trial

NCT03824158 | Completed Results

• 2 other identifiers: STUDY190803371R01CA235730-01
• Study Type: interventional
• Target: 672
• Locations: 1 country
• Sites: 1

Brief Summary

The overall goal of this study is to identify the most effective and efficient advance care planning (ACP) strategy for patients with advanced cancer. The specific aims are to: Aim 1. Compare the effectiveness of in-person, facilitated ACP versus web-based ACP on patient and family caregiver outcomes. Aim 2. Assess implementation costs and the effects of in-person, facilitated ACP and web-based ACP on healthcare utilization at end of life. Aim 3. Identify contexts and mechanisms that influence the effectiveness of in-person, facilitated ACP versus web-based ACP.

Conditions

Cancer; Advance Care Planning

Keywords

cancer, advance care planning

Outcome Measures

Primary Outcomes (1)

• Advance Care Planning Engagement

  15-item Advance Care Planning (ACP) engagement survey assesses ACP processes related to choosing a medical decision maker, discussing and documenting preference for care at end of life, flexibility for surrogate decision making, and asking questions of medical providers. A single summary score will be reported (range 0-5 with higher scores indicating higher engagement).

  12 weeks

Secondary Outcomes (12)

• Number of Participants Who Have Had Advance Care Planning Discussions With Caregivers

  12 weeks

• Number of Participants Who Have Had Advance Care Planning Discussions With Physicians

  12 weeks

• Number of Participants Who Have Completed an Advance Directive

  12 weeks

• Documented Care Goals

  12 weeks

• Caregiver Depression Symptoms

  12 weeks

Other Outcomes (8)

• Number of Participants Who Received Chemotherapy Within Last 2 Weeks of Life

  Assessed after patient death

• Number of Participants Admitted to an Intensive Care Unit Within Last 30 Days of Life

  Assessed after patient death

• Number of Participants Admitted to Hospice Within Last 30 Days of Life

  Assessed after patient death

Study Arms (2)

Facilitated advance care planning (in-person or telephonic)

ACTIVE COMPARATOR

Patients randomized to this arm will participate in in-person or telephonic facilitated advance care planning (ACP) discussions using the Respecting Choices model.

Behavioral: Facilitated advance care planning (in-person or telephonic)

Web-based advance care planning

ACTIVE COMPARATOR

Patients randomized to this arm will participate in web-based ACP via the PREPARE website.

Behavioral: Web-based advance care planning

Interventions

Facilitated advance care planning (in-person or telephonic) BEHAVIORAL

The facilitator will contact the patient to schedule the ACP discussion. ACP discussions will be led by a nurse or social worker with supportive oncology experience who has been trained as a Respecting Choices facilitator, include the patient's caregiver when available, last 45-60 minutes, and be held in a private location at or near the patient's oncology clinic, or telephonically. Facilitators will use a structured interview tool as a discussion roadmap and provide guidance in choosing a medical decision maker, exploring serious illness understanding and experiences, identifying goals and values, and making future treatment decisions. Facilitators will provide a copy of a written advance directive, assist with completion when appropriate, and make recommendations for communicating goals and sharing written preferences.

Facilitated advance care planning (in-person or telephonic)

Web-based advance care planning BEHAVIORAL

Instructions for accessing and using the PREPARE website will be shared with participants upon randomization. Patients and their caregivers review the 5 steps of PREPARE (approximately 10 minutes per step) and create an action plan for each step. The PREPARE website includes a link to a written advance directive that participants are able to complete. The PREPARE website can be reviewed on a home computer or on a tablet in the oncology practice.

Web-based advance care planning

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• years of age or older
• Solid tumor
• The oncologist "would not be surprised" if the patient died within the next year
• Eastern Cooperative Oncology Group performance status (ECOG PS) of 0, 1, or 2
• Planning to receive ongoing care at a participating oncology clinic
• Willing to participate in either a web-based or facilitated program

You may not qualify if:

• Does not speak English
• Inability to consent, using a validated teach-back method
• Hematologic malignancy
• No phone for additional study contacts and follow-up interviews
• Unable to participate in advance care planning, as assessed by clinician
• Unable to complete the baseline interview
• Patients will be able to identify and enroll a caregiver, designated by the patient as the primary family member or friend involved in their care and best able to participate in the study.
• years of age or older
• Family member or friend of an eligible patient
• Primary person involved in patient's care and best able to participate in the study, as assessed by patient
• Does not speak English
• No phone for additional study contacts and follow-up interviews
• Unable to complete the baseline interview

Sponsors & Collaborators

• University of Pittsburgh: lead
• National Cancer Institute (NCI): collaborator

Study Sites (1)

UPMC Hillman Cancer Center

Pittsburgh, Pennsylvania, 15232, United States

Location

Related Publications (1)

• Schenker Y, Belin SC, Wang T, Sudore RL, Hammes B, Arnold RM, Flowers R, Chiu E, Hall J, Dudley-Morrissey Y, Ferrell B, Crowley-Matoka M, Brufsky A, Chu E, Gorantla V, Mehta D, Thomas R, Yee M, White D. Facilitated Versus Patient-Directed Advance Care Planning Among Patients With Advanced Cancer: A Randomized Clinical Trial. JCO Oncol Pract. 2025 Oct;21(10):1447-1457. doi: 10.1200/OP-25-00046. Epub 2025 Mar 19.

  PMID: 40106743 DERIVED

MeSH Terms

Conditions

Neoplasms

Results Point of Contact

• Title: Yael Schenker, MD, MAS, FAAHPM
• Organization: University of Pittsburgh

yas28@pitt.edu

415-254-9958

Study Officials

• Yael Schenker, MD, MPH

  University of Pittsburgh

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: January 24, 2019
• First Posted: January 31, 2019
• Study Start: August 1, 2019
• Primary Completion: January 1, 2024
• Study Completion: July 30, 2025
• Last Updated: January 14, 2026
• Results First Posted: January 17, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)