CancerNCT03824158
Patient-centered and Efficacious Advance Care Planning in Cancer: the PEACe Comparative Effectiveness Trial
A study testing Facilitated advance care planning (in-person or telephonic) and Web-based advance care planning in people with Cancer and Advance Care Planning, run by University of Pittsburgh at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cancer, Advance Care Planning
- What is being tested?
- Facilitated advance care planning (in-person or telephonic) and Web-based advance care planning
- Type of treatment
- Pill or oral medicine, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 672 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Aug 2019to 30 Jul 2025
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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 locations and contacts
1 site in 1 country.
United States1 site
UPMC Hillman Cancer Center
Pittsburgh, Pennsylvania, 15232
About this study
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.
Read the 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.
- Conditions
- Cancer, Advance Care Planning
- Being tested
- Facilitated advance care planning (in-person or telephonic), Web-based advance care planning
- Keywords
- cancer, advance care planning
- Medical subject headings
- Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Facilitated advance care planning (in-person or telephonic)Behavioural
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.
Web-based advance care planningBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Facilitated advance care planning (in-person or telephonic) | Active comparator | Patients randomized to this arm will participate in in-person or telephonic facilitated advance care planning (ACP) discussions using the Respecting Choices model. Receives: Behavioral: Facilitated advance care planning (in-person or telephonic) |
| Web-based advance care planning | Active comparator | Patients randomized to this arm will participate in web-based ACP via the PREPARE website. Receives: Behavioral: Web-based advance care planning |
What is being measured
The primary outcome is the main question the study is designed to answer.
Advance Care Planning Engagement
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).
Measured: 12 weeks
Secondary outcomes (12)
Number of Participants Who Have Had 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?"
Measured: 12 weeks
Number of Participants Who Have Had 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?"
Measured: 12 weeks
Number of Participants Who Have Completed an Advance Directive
"Has [participant] completed a living will or advance directive?"
Measured: 12 weeks
Documented Care Goals
Investigators will assess documented care goals by reviewing medical records for any care goals documented since baseline (Yes/No).
Measured: 12 weeks
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.
Measured: 12 weeks
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.
Measured: 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."
Measured: 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.
Measured: 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. Total score range is 13-26, with higher scores indicating better perceived quality of care. Prolongation of Death, Perceived Suffering, and Preparation for the Death Subscales range 3-6, with higher scores indicating a better outcome. Shared Decision-Making subscale range is 4-8, with higher scores indicating a better outcome.
Measured: 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 a higher total score indicating more post-traumatic stress symptoms. Avoidance, Intrusions, and Hyperarousal Subscales range 0-4, with higher scores indicating a worse outcome.
Measured: 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.
Measured: 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.
Measured: during bereavement, up to 60 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jan 2019
- Study start1 Aug 2019
- Primary completion1 Jan 2024
- Study completion30 Jul 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for CancerStudies of the same condition, open and under way.
- More trials run by University of PittsburghThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 672 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Pittsburgh
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Principal investigator, Yael Schenker, MD, MAS, University of Pittsburgh
- Investigators
- Yael Schenker, MD, MPH, Principal investigator, University of Pittsburgh
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03824158
- Sponsor's protocol ID
- STUDY19080337
- Other IDs
- 1R01CA235730-01
- Status last verified
- Dec 2025
- First submitted
- 24 Jan 2019
- Last updated
- 14 Jan 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Crowley F, Belin S, Wang T, Applebaum A, Ferrell B, Flowers R, Sudore R, White D, Crowley-Makota M, Hammes B, Arnold R, Schenker Y. Advance care planning impact on caregivers and end-of-life care in advanced cancer. J Natl Cancer Inst. 2026 Apr 1;118(4):626-635. doi: 10.1093/jnci/djaf331.
PubMed 41233979Schenker Y, Belin SC, Wang T, Sudore RL, Hammes B, Arnold RM, Flowers R, Chiu E, Hall J, Dudley-Morrissey Y, Ferrell B, Crowley-Matoka M, Brufsky A, Chu E, Gorantla V, Mehta D, Thomas R, Yee M, White D. Facilitated Versus Patient-Directed Advance Care Planning Among Patients With Advanced Cancer: A Randomized Clinical Trial. JCO Oncol Pract. 2025 Oct;21(10):1447-1457. doi: 10.1200/OP-25-00046. Epub 2025 Mar 19.
PubMed 40106743
Study at a glance
From the registry record, last updated by the sponsor on 14 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Patient-centered and Efficacious Advance Care Planning in Cancer: the PEACe Comparative Effectiveness Trial
- ClinicalTrials.gov ID
- NCT03824158
- Acronym / sponsor ID
- STUDY19080337
- Conditions
- Cancer, Advance Care Planning
- Keywords
- cancer, advance care planning
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 672 participants (actual)
- Lead sponsor
- University of PittsburghUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- 1 Aug 2019 (actual)
- Primary completion
- 1 Jan 2024 (actual)
- Study completion
- 30 Jul 2025 (actual)
- First posted
- 31 Jan 2019 (actual)
- Results
- Posted 17 Jan 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Facilitated advance care planning (in-person or telephonic) | Active comparator | Behavioral: 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. |
| Web-based advance care planning | Active comparator | Behavioral: Web-based advance care planningPatients randomized to this arm will participate in web-based ACP via the PREPARE website. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Facilitated advance care planning (in-person or telephonic)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. | Behavioural | Facilitated advance care planning (in-person or telephonic) |
| Web-based advance care planningInstructions 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. | Behavioural | Web-based advance care planning |
Primary outcome
Advance Care Planning Engagement
Time frame: 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).
12 secondary outcomes
Number of Participants Who Have Had Advance Care Planning Discussions With Caregivers
Time frame: 12 weeks
Number of Participants Who Have Had Advance Care Planning Discussions With Physicians
Time frame: 12 weeks
Number of Participants Who Have Completed an Advance Directive
Time frame: 12 weeks
Documented Care Goals
Time frame: 12 weeks
Caregiver Depression Symptoms
Time frame: 12 weeks
Caregiver Anxiety Symptoms
Time frame: 12 weeks
Receipt of Goal-concordant End-of-life Care - Patient Wishes Followed
Time frame: during bereavement, up to 60 months
Receipt of Goal-concordant End-of-life Care - Place of Death
Time frame: during bereavement, up to 60 months
Quality of End-of-life Care
Time frame: during bereavement, up to 60 months
Caregiver Post-traumatic Stress Symptoms
Time frame: during bereavement, up to 60 months
Caregiver Depression Symptoms
Time frame: bereavement, up to 60 months
Caregiver Anxiety Symptoms
Time frame: during bereavement, up to 60 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jan 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 41233979Crowley F, Belin S, Wang T, Applebaum A, Ferrell B, Flowers R, Sudore R, White D, Crowley-Makota M, Hammes B, Arnold R, Schenker Y. Advance care planning impact on caregivers and end-of-life care in advanced cancer. J Natl Cancer Inst. 2026 Apr 1;118(4):626-635. doi: 10.1093/jnci/djaf331.
- Derived from this study: PubMed 40106743Schenker Y, Belin SC, Wang T, Sudore RL, Hammes B, Arnold RM, Flowers R, Chiu E, Hall J, Dudley-Morrissey Y, Ferrell B, Crowley-Matoka M, Brufsky A, Chu E, Gorantla V, Mehta D, Thomas R, Yee M, White D. Facilitated Versus Patient-Directed Advance Care Planning Among Patients With Advanced Cancer: A Randomized Clinical Trial. JCO Oncol Pract. 2025 Oct;21(10):1447-1457. doi: 10.1200/OP-25-00046. Epub 2025 Mar 19.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Yael Schenker, MD, MPH principal investigator
University of Pittsburgh
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Facilitated advance care planning (in-person or telephonic) and Web-based advance care planning in people with Cancer and Advance Care Planning, run by University of Pittsburgh at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 17 Jan 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Advance Care Planning Engagement (time frame: 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03824158, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Jan 2026.