Clinical trial NCT03824158: Patient-centered and Efficacious Advance Care Planning in Cancer: the PEACe Comparative Effectiveness Trial
Official title: Patient-centered and Efficacious Advance Care Planning in Cancer: the PEACe Comparative Effectiveness Trial
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Cancer
Advance Care Planning
Keywords: cancer, advance care planning
Lead sponsor: University of Pittsburgh
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2019-01-31
Enrollment: 672
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

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.

Eligibility criteria: Patient Inclusion Criteria:

1. 18 years of age or older
2. Solid tumor
3. The oncologist "would not be surprised" if the patient died within the next year
4. Eastern Cooperative Oncology Group performance status (ECOG PS) of 0, 1, or 2
5. Planning to receive ongoing care at a participating oncology clinic
6. Willing to participate in either a web-based or facilitated program

Patient Exclusion Criteria:

1. Does not speak English
2. Inability to consent, using a validated teach-back method
3. Hematologic malignancy
4. No phone for additional study contacts and follow-up interviews
5. Unable to participate in advance care planning, as assessed by clinician
6. 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.

Caregiver Inclusion criteria:

1. 18 years of age or older
2. Family member or friend of an eligible patient
3. Primary person involved in patient's care and best able to participate in the study, as assessed by patient

Caregiver Exclusion criteria:

1. Does not speak English
2. No phone for additional study contacts and follow-up interviews
3. Unable to complete the baseline interview

Primary outcomes:
measure: Advance Care Planning Engagement
timeFrame: 12 weeks
Secondary outcomes:
measure: Number of Participants Who Have Had Advance Care Planning Discussions With Caregivers
timeFrame: 12 weeks
measure: Number of Participants Who Have Had Advance Care Planning Discussions With Physicians
timeFrame: 12 weeks
measure: Number of Participants Who Have Completed an Advance Directive
timeFrame: 12 weeks
measure: Documented Care Goals
timeFrame: 12 weeks
measure: Caregiver Depression Symptoms
timeFrame: 12 weeks
measure: Caregiver Anxiety Symptoms
timeFrame: 12 weeks
measure: Receipt of Goal-concordant End-of-life Care - Patient Wishes Followed
timeFrame: during bereavement, up to 60 months
measure: Receipt of Goal-concordant End-of-life Care - Place of Death
timeFrame: during bereavement, up to 60 months
measure: Quality of End-of-life Care
timeFrame: during bereavement, up to 60 months
measure: Caregiver Post-traumatic Stress Symptoms
timeFrame: during bereavement, up to 60 months
measure: Caregiver Depression Symptoms
timeFrame: bereavement, up to 60 months
measure: Caregiver Anxiety Symptoms
timeFrame: during bereavement, up to 60 months
Other outcomes:
measure: Healthcare Utilization at End of Life - Chemotherapy
timeFrame: during bereavement, up to 60 months
measure: Healthcare Utilization at End of Life - ICU
timeFrame: during bereavement, up to 60 months
measure: Healthcare Utilization at End of Life - Hospice
timeFrame: during bereavement, up to 60 months
measure: Healthcare Utilization at End of Life - Hospice < 3 Days
timeFrame: during bereavement, up to 60 months
measure: Healthcare Utilization at End of Life - Hospice Length of Stay
timeFrame: during bereavement, up to 60 months
measure: Healthcare Utilization at End of Life - Hospitalizations
timeFrame: during bereavement, up to 60 months
measure: Healthcare Utilization at End of Life - ED Visits
timeFrame: during bereavement, up to 60 months
measure: Advance Care Planning Implementation Costs
timeFrame: through study completion, up to 5 years
Locations:
city: Pittsburgh
country: United States
facility: UPMC Hillman Cancer Center
state: Pennsylvania
Study officials:
affiliation: University of Pittsburgh
name: Yael Schenker, MD, MPH
role: PRINCIPAL_INVESTIGATOR
References: