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



Status:Not yet recruiting
Conditions:Cancer, Cancer
Therapuetic Areas:Oncology
Healthy:No
Age Range:18 - Any
Updated:2/2/2019
Start Date:March 2019
End Date:February 2024
Contact:Yael Schenker, MD, MAS
Email:yas28@pitt.edu
Phone:412-864-2375

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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.

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.

Patient Inclusion Criteria:

1. adults (≥ 18 years old);

2. solid tumor;

3. the oncologist "would not be surprised if the patient died in the next year";

4. Eastern Cooperative Oncology Group performance status (ECOG PS) of ≤ 2.

Patient Exclusion Criteria:

1. does not speak English;

2. inability to consent to treatment, using a validated teach-back method; and

3. hematologic malignancy.

Patients will be able to identify and enroll a caregiver, designated by the patient as the
primary person involved in their care and best able to participate in the study.

Caregiver Inclusion criteria:

1. adults (≥ 18 years old);

2. family member or friend of an eligible patient.

Caregiver Exclusion criteria:

1. does not speak English;

2. inability to consent to treatment, using a validated teach-back method.
We found this trial at
1
site
Pittsburgh, Pennsylvania 15232
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from
Pittsburgh, PA
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