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

Study Overview
=================
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.

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

Conditions
-----------------
Cancer, Advance Care Planning

Intervention / Treatment
-----------------
* Behavioral: Facilitated advance care planning (in-person or telephonic)
* Behavioral: Web-based advance care planning


Participation Criteria
=================
Eligibility 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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Facilitated advance care planning (in-person or telephonic)<br>Patients randomized to this arm will participate in in-person or telephonic facilitated advance care planning (ACP) discussions using the Respecting Choices model. | Behavioral: Facilitated advance care planning (in-person or telephonic)<br>* 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.<br>|
| Active Comparator: Web-based advance care planning<br>Patients randomized to this arm will participate in web-based ACP via the PREPARE website. | Behavioral: Web-based advance care planning<br>* 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.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Advance care planning engagement | 15-item 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). | 12 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| advance care planning discussions with caregivers | 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? | 12 weeks | 
| advance care planning discussions with physicians | 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? | 12 weeks | 
| advance directive completion | Has [participant] completed a living will or advance directive? | 12 weeks | 
| documented care goals | Investigators will assess documented care goals by reviewing medical records for any care goals documented since baseline (Yes/No). | 12 weeks | 
| Receipt of goal-concordant end-of-life care - patient wishes followed | 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. | during bereavement, up to 60 months | 
| Receipt of goal-concordant end-of-life care - place of death | 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. | during bereavement, up to 60 months | 
| quality of end-of-life care | 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). | during bereavement, up to 60 months | 
| caregiver depression symptoms | 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. | 12 weeks and bereavement up to 60 months | 
| caregiver anxiety symptoms | 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. | 12 weeks and during bereavement, up to 60 months | 
| caregiver post-traumatic stress symptoms | 22-item Impact of Events Scale-revised has a scoring range from 0-88, with higher scores indicating more post-traumatic stress symptoms. | during bereavement, up to 60 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
cancer, advance care planning