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

Not Applicable

Active, not recruiting

Conditions: Advance Care Planning
Cancer

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

Registration Number: NCT03824158

Lead Sponsor: University of Pittsburgh

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.

Recruitment & Eligibility

Status: ACTIVE_NOT_RECRUITING

Sex: All

Target Recruitment: 672

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

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Web-based advance care planning	Web-based advance care planning	Patients randomized to this arm will participate in web-based ACP via the PREPARE website.
Facilitated advance care planning (in-person or telephonic)	Facilitated advance care planning (in-person or telephonic)	Patients randomized to this arm will participate in in-person or telephonic facilitated advance care planning (ACP) discussions using the Respecting Choices model.

Primary Outcome Measures

Name	Time	Method
Advance Care Planning Engagement	12 weeks	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).

Secondary Outcome Measures

Name	Time	Method
Number of Participants Who Have Had Advance Care Planning Discussions With Caregivers	12 weeks	"Has \[participant\] talked with \[participant's\] family or friends about the kind of medical care \[participant\] would want if \[participant\] were very sick or near the end of life?"
Number of Participants Who Have Had Advance Care Planning Discussions With Physicians	12 weeks	"Has \[participant\] talked with \[participant's\] doctor about the kind of medical care \[participant\] would want if \[participant\] were very sick or near the end of life?"
Number of Participants Who Have Completed an Advance Directive	12 weeks	"Has \[participant\] completed a living will or advance directive?"
Documented Care Goals	12 weeks	Investigators will assess documented care goals by reviewing medical records for any care goals documented since baseline (Yes/No).
Caregiver Depression Symptoms	bereavement, up to 60 months	Depression subscale of the 14-item Hospital Anxiety and Depression Scale (HADS) will be used to assess caregiver depression symptoms at 12 weeks and bereavement. The HADS depression subscale scores range from 0 to 21, with higher scores indicating more distress.
Caregiver Anxiety Symptoms	during bereavement, up to 60 months	Anxiety subscale of the 14-item Hospital Anxiety and Depression Scale (HADS) will be used to assess caregiver anxiety symptoms at 12 weeks and bereavement. The anxiety subscale scores range from 0 to 21, with higher scores indicating more distress.
Receipt of Goal-concordant End-of-life Care - Patient Wishes Followed	during bereavement, up to 60 months	Bereaved caregivers will be asked "In \[participant's\] opinion, to what extent were \[the patient's\] wishes followed in the medical care received in the last month of life?" Receipt of goal-concordant end-of-life care - patient wishes followed will be defined as care that "followed patients' wishes a great deal."
Receipt of Goal-concordant End-of-life Care - Place of Death	during bereavement, up to 60 months	Bereaved caregivers will be asked about patient's preferred and actual places of death, with questions separated in the survey to minimize conscious comparison. Receipt of goal-concordant end-of-life care - place of death will be defined as patients dying in their preferred location.
Quality of End-of-life Care	during bereavement, up to 60 months	13-item Caregiver Evaluation of Quality of End-of-Life Care (CEQUEL) scale. A single summary score will be reported (range of scores 13-26, with higher scores indicating better perceived quality of care).
Caregiver Post-traumatic Stress Symptoms	during bereavement, up to 60 months	22-item Impact of Events Scale-revised has a scoring range from 0-88, with higher scores indicating more post-traumatic stress symptoms.