NCT03824158

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 672 (actual)
• Sponsor: University of Pittsburgh · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

Study investigators will conduct a single-blind, patient-level randomized trial to compare the effectiveness of two different patient-facing advance care planning (ACP) interventions. Investigators will enroll 400 patients with advanced cancer and their family caregivers to receive either (1) in-person discussions with trained facilitators or (2) web-based ACP using interactive videos. Because these approaches have never been compared directly, it is unclear whether one form of advance care planning is more potent, and if so, for whom and under what circumstances. Aim 1 compares the effectiveness of in-person, facilitated ACP versus web-based ACP on patient and family caregiver outcomes (ACP engagement, ACP discussions, advance directive completion, goal attainment, and caregiver psychological symptoms). Aim 2 assesses implementation costs of each intervention and effects on healthcare utilization at end of life. Aim 3 identifies contexts and mechanisms influencing the effectiveness of each approach. Primary patient outcomes will be assessed at 12 weeks. Participants will be followed until 12 weeks after the patient's death or completion of the 48-month data collection period, whichever occurs first. In-depth interviews with patients, caregivers, and clinicians will begin in Year 2 of the grant and continue until thematic saturation is reached.

Conditions

• Cancer
• Advance Care Planning

Interventions

Type	Name	Description
BEHAVIORAL	Facilitated advance care planning (in-person or telephonic)	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.
BEHAVIORAL	Web-based advance care planning	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.

Timeline

• Start date: 2019-08-01
• Primary completion: 2024-01-01
• Completion: 2025-07-30
• First posted: 2019-01-31
• Last updated: 2026-01-14
• Results posted: 2025-01-17

Locations

1 site across 1 country: United States