Patient-centered and Efficacious Advance Care Planning in Cancer: the PEACe Comparative Effectiveness Trial
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Details and patient eligibility
About
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.
Full 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.
Enrollment
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Volunteers
Inclusion and exclusion criteria
Patient Inclusion Criteria:
- 18 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
Patient Exclusion Criteria:
- 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.
Caregiver Inclusion criteria:
- 18 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
Caregiver Exclusion criteria:
- Does not speak English
- No phone for additional study contacts and follow-up interviews
- Unable to complete the baseline interview
Trial design
Primary purpose
Allocation
Interventional model
Masking
672 participants in 2 patient groups
Trial contacts and locations
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Data sourced from clinicaltrials.gov
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