CClinicalTrials.gg
CompletedNCT03824158Updated Jan 14, 2026Results posted

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

An interventional study of Facilitated advance care planning (in-person or telephonic) and Web-based advance care planning in Cancer and Advance Care Planning, sponsored by University of Pittsburgh. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-01-14.

Sponsored by University of Pittsburgh · Not applicable, Interventional, and Supportive care

Phase
Not applicable
Study type
Interventional
Enrollment
672
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study 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.

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.

02

Conditions studied

  • Cancer
  • Advance Care Planning

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Keywords

  • cancer, advance care planning
03

In context

Neoplasms

9,365 studies on the registry are indexed under Neoplasms; 2,489 are open to participants now.

This study's enrollment of 672 is above the median of 50 across 7,253 interventional studies indexed under Neoplasms.

Browse Neoplasms studies →

Lead sponsor

University of Pittsburgh is the lead sponsor of 1,385 studies on the registry; 167 are open to participants now.

Of its 8 completed or terminated interventional studies of FDA-regulated products, 4 (50%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

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
05

Study design

Phase
Not applicable
Primary purpose
Supportive care
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Outcomes assessor)
Enrollment
672 participants (actual)

Study arms

  • Active comparator
    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.

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

  • Active comparator
    Web-based advance care planning

    Patients randomized to this arm will participate in web-based ACP via the PREPARE website.

    Behavioral: Web-based advance care planning

Interventions

  • BehavioralFacilitated 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.

  • BehavioralWeb-based advance care planning

    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.

06

What researchers measure

Primary outcomes

  1. 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).

    Time frame: 12 weeks

Secondary outcomes

  1. 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?"

    Time frame: 12 weeks

  2. 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?"

    Time frame: 12 weeks

  3. Number of Participants Who Have Completed an Advance Directive

    "Has \[participant\] completed a living will or advance directive?"

    Time frame: 12 weeks

  4. Documented Care Goals

    Investigators will assess documented care goals by reviewing medical records for any care goals documented since baseline (Yes/No).

    Time frame: 12 weeks

  5. 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.

    Time frame: 12 weeks

  6. 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.

    Time frame: 12 weeks

  7. 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."

    Time frame: during bereavement, up to 60 months

  8. 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.

    Time frame: during bereavement, up to 60 months

  9. 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.

    Time frame: during bereavement, up to 60 months

  10. 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.

    Time frame: during bereavement, up to 60 months

  11. 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.

    Time frame: bereavement, up to 60 months

  12. 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.

    Time frame: during bereavement, up to 60 months

Other outcomes

  1. Number of Participants Who Received Chemotherapy Within Last 2 Weeks of Life

    Investigators will measure whether chemotherapy was administered within the last 2 weeks of life (Y/N)

    Time frame: Assessed after patient death

  2. Number of Participants Admitted to an Intensive Care Unit Within Last 30 Days of Life

    Investigators will measure whether participant was admitted to the intensive care unit in the last 30 days of life (Y/N)

    Time frame: Assessed after patient death

  3. Number of Participants Admitted to Hospice Within Last 30 Days of Life

    Investigators will measure whether the participant was admitted to hospice (Y/N)

    Time frame: Assessed after patient death

  4. Number of Participants Admitted to Hospice Within Last 3 Days of Life

    Investigators will measure whether the participant was admitted to hospice for \< 3 days (Y/N)

    Time frame: Assessed after patient death

  5. Healthcare Utilization at End of Life - Hospice Length of Stay

    For participants admitted to hospice, investigators will measure number of days in hospice.

    Time frame: Assessed after patient death

  6. Number of Participants Who Were Hospitalized Within Last 30 Days of Life

    Investigators will measure the number of participants hospitalized within in the last 30 days of life

    Time frame: Assess after patient death

  7. Number of Participants Who Had Emergency Department Visits Within Last 30 Days of Life

    Investigators will measure number of emergency department visits in the last 30 days of life

    Time frame: Assessed after patient death

  8. Advance Care Planning Implementation Costs

    Investigators will assess advance care planning implementation costs by tracking staff time spent on each intervention arm. Staff time costs for each intervention will be estimated by multiplying staff training and patient care time related to the intervention in hours by the average hourly wage for US nursing and social work staff of comparable levels.

    Time frame: through study completion, up to 5 years

07

Results

Posted Jan 17, 2025

Participant flow

Recruitment occurred from August 1, 2019 until July 14, 2023. Patients were enrolled from 8 oncology clinics within the University of Pittsburgh Medical Center Hillman Cancer Center Network in western Pennsylvania. Patients were encouraged but not required to identify a caregiver, defined as the primary adult (family member or friend) involved in their care and best able to participate in the study, as assessed by the patient. Patients without a willing caregiver participant were not excluded.

Participant flow — Overall Study
MilestoneWeb-based Advance Care Planning (PATIENTS)Facilitated Advance Care Planning (In-person or Telephonic) (PATIENTS)Web-based Advance Care Planning (CAREGIVERS)Facilitated Advance Care Planning (In-person or Telephonic) (CAREGIVERS)
Started203197133139
Completed134135102108
Not completed69623131

Outcome measures

PrimaryAdvance 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).

Time frame:
12 weeks
Reported as:
Mean · score on a scale
Advance Care Planning Engagement
score on a scaleWeb-based Advance Care Planning (PATIENTS)Facilitated Advance Care Planning (In-person or Telephonic) (PATIENTS)
Advance Care Planning Engagement4.08 ± 0.824.34 ± 0.78
Statistical analysis
  • Web-based Advance Care Planning (PATIENTS) vs Facilitated Advance Care Planning (In-person or Telephonic) (PATIENTS) · Mixed Models Analysis · p = 0.0014
SecondaryNumber 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?"

Time frame:
12 weeks
Reported as:
Count of participants · Participants
Number of Participants Who Have Had Advance Care Planning Discussions With Caregivers
ParticipantsWeb-based Advance Care Planning (PATIENTS)Facilitated Advance Care Planning (In-person or Telephonic) (PATIENTS)
Number of Participants Who Have Had Advance Care Planning Discussions With Caregivers117120
Statistical analysis
  • Web-based Advance Care Planning (PATIENTS) vs Facilitated Advance Care Planning (In-person or Telephonic) (PATIENTS) · Regression, Logistic · p = 0.76
SecondaryNumber 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?"

Time frame:
12 weeks
Reported as:
Count of participants · Participants
Number of Participants Who Have Had Advance Care Planning Discussions With Physicians
ParticipantsWeb-based Advance Care Planning (PATIENTS)Facilitated Advance Care Planning (In-person or Telephonic) (PATIENTS)
Number of Participants Who Have Had Advance Care Planning Discussions With Physicians5467
Statistical analysis
  • Web-based Advance Care Planning (PATIENTS) vs Facilitated Advance Care Planning (In-person or Telephonic) (PATIENTS) · Mixed Models Analysis · p = 0.13
SecondaryNumber of Participants Who Have Completed an Advance Directive

"Has \[participant\] completed a living will or advance directive?"

Time frame:
12 weeks
Reported as:
Count of participants · Participants
Number of Participants Who Have Completed an Advance Directive
ParticipantsWeb-based Advance Care Planning (PATIENTS)Facilitated Advance Care Planning (In-person or Telephonic) (PATIENTS)
Number of Participants Who Have Completed an Advance Directive80101
Statistical analysis
  • Web-based Advance Care Planning (PATIENTS) vs Facilitated Advance Care Planning (In-person or Telephonic) (PATIENTS) · Mixed Models Analysis · p = 0.008
SecondaryDocumented Care Goals

Investigators will assess documented care goals by reviewing medical records for any care goals documented since baseline (Yes/No).

Time frame:
12 weeks
Reported as:
Number · participants
Documented Care Goals
participantsWeb-based Advance Care Planning (PATIENTS)Facilitated Advance Care Planning (In-person or Telephonic) (PATIENTS)
New advance directive or living will418
New Physician Orders for Life-sustaining Treatment (POLST) form18
New Code Status2931
New Goals of Care discussion2622
Statistical analysis
  • Web-based Advance Care Planning (PATIENTS) vs Facilitated Advance Care Planning (In-person or Telephonic) (PATIENTS) · Chi-squared · p = 0.002
  • Web-based Advance Care Planning (PATIENTS) vs Facilitated Advance Care Planning (In-person or Telephonic) (PATIENTS) · Fisher Exact · p = 0.02
  • Web-based Advance Care Planning (PATIENTS) vs Facilitated Advance Care Planning (In-person or Telephonic) (PATIENTS) · Chi-squared · p = 0.78
  • Web-based Advance Care Planning (PATIENTS) vs Facilitated Advance Care Planning (In-person or Telephonic) (PATIENTS) · Chi-squared · p = 0.61
SecondaryCaregiver 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.

Time frame:
12 weeks
Reported as:
Mean · score on a scale
Caregiver Depression Symptoms
score on a scaleWeb-based Advance Care Planning (CAREGIVERS)Facilitated Advance Care Planning (In-person or Telephonic) (CAREGIVERS)
Caregiver Depression Symptoms4.34 ± 4.073.69 ± 3.57
Statistical analysis
  • Web-based Advance Care Planning (CAREGIVERS) vs Facilitated Advance Care Planning (In-person or Telephonic) (CAREGIVERS) · Mixed Models Analysis · p = 0.17
SecondaryCaregiver 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.

Time frame:
12 weeks
Reported as:
Mean · score on a scale
Caregiver Anxiety Symptoms
score on a scaleWeb-based Advance Care Planning (CAREGIVERS)Facilitated Advance Care Planning (In-person or Telephonic) (CAREGIVERS)
Caregiver Anxiety Symptoms6.94 ± 4.66.5 ± 3.92
Statistical analysis
  • Web-based Advance Care Planning (CAREGIVERS) vs Facilitated Advance Care Planning (In-person or Telephonic) (CAREGIVERS) · Mixed Models Analysis · p = 0.11
SecondaryReceipt 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."

Time frame:
during bereavement, up to 60 months
Reported as:
Count of participants · Participants
Receipt of Goal-concordant End-of-life Care - Patient Wishes Followed
ParticipantsWeb-based Advance Care Planning (CAREGIVERS)Facilitated Advance Care Planning (In-person or Telephonic) (CAREGIVERS)
A great deal3746
Somewhat112
Not at all10
Did not answer10
Statistical analysis
  • Web-based Advance Care Planning (CAREGIVERS) vs Facilitated Advance Care Planning (In-person or Telephonic) (CAREGIVERS) · Fisher Exact · p = 0.01
SecondaryReceipt 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.

Time frame:
during bereavement, up to 60 months
Reported as:
Count of participants · Participants
Receipt of Goal-concordant End-of-life Care - Place of Death
ParticipantsWeb-based Advance Care Planning (CAREGIVERS)Facilitated Advance Care Planning (In-person or Telephonic) (CAREGIVERS)
Receipt of Goal-concordant End-of-life Care - Place of Death3437
Statistical analysis
  • Web-based Advance Care Planning (CAREGIVERS) vs Facilitated Advance Care Planning (In-person or Telephonic) (CAREGIVERS) · Fisher Exact · p = 0.83
SecondaryQuality 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.

Time frame:
during bereavement, up to 60 months
Reported as:
Mean · score on a scale
Quality of End-of-life Care
score on a scaleWeb-based Advance Care Planning (CAREGIVERS)Facilitated Advance Care Planning (In-person or Telephonic) (CAREGIVERS)
Prolongation of Death subscale5.62 ± 0.785.69 ± 0.62
Perceived Suffering Subscale5.51 ± 0.835.45 ± 0.91
Shared Decision-Making subscale7.67 ± 0.747.7 ± 0.68
Preparation for the Death subscale5.66 ± 0.725.51 ± 0.72
Total Score24.45 ± 2.0524.35 ± 1.83
Statistical analysis
  • Web-based Advance Care Planning (CAREGIVERS) vs Facilitated Advance Care Planning (In-person or Telephonic) (CAREGIVERS) · Wilcoxon (Mann-Whitney) · p = 0.32 (Total Score p-value)
SecondaryCaregiver 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.

Time frame:
during bereavement, up to 60 months
Reported as:
Mean · score on a scale
Caregiver Post-traumatic Stress Symptoms
score on a scaleWeb-based Advance Care Planning (CAREGIVERS)Facilitated Advance Care Planning (In-person or Telephonic) (CAREGIVERS)
Avoidance subscale1.15 ± 0.640.96 ± 0.79
Intrusions Subscale1.99 ± 0.891.48 ± 0.86
Hyperarousal Subscale1.06 ± 0.840.74 ± 0.64
IES-R Total Score31.5 ± 15.223.9 ± 14.6
Statistical analysis
  • Web-based Advance Care Planning (CAREGIVERS) vs Facilitated Advance Care Planning (In-person or Telephonic) (CAREGIVERS) · t-test, 2 sided · p = 0.01
SecondaryCaregiver 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.

Time frame:
bereavement, up to 60 months
Reported as:
Mean · score on a scale
Caregiver Depression Symptoms
score on a scaleWeb-based Advance Care Planning (CAREGIVERS)Facilitated Advance Care Planning (In-person or Telephonic) (CAREGIVERS)
Caregiver Depression Symptoms5.87 ± 4.115.34 ± 6.56
Statistical analysis
  • Web-based Advance Care Planning (CAREGIVERS) vs Facilitated Advance Care Planning (In-person or Telephonic) (CAREGIVERS) · t-test, 2 sided · p = 0.50
SecondaryCaregiver 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.

Time frame:
during bereavement, up to 60 months
Reported as:
Mean · score on a scale
Caregiver Anxiety Symptoms
score on a scaleWeb-based Advance Care Planning (CAREGIVERS)Facilitated Advance Care Planning (In-person or Telephonic) (CAREGIVERS)
Caregiver Anxiety Symptoms6.72 ± 4.596.56 ± 3.32
Statistical analysis
  • Web-based Advance Care Planning (CAREGIVERS) vs Facilitated Advance Care Planning (In-person or Telephonic) (CAREGIVERS) · t-test, 2 sided · p = 0.84
Other pre-specifiedNumber of Participants Who Received Chemotherapy Within Last 2 Weeks of Life

Investigators will measure whether chemotherapy was administered within the last 2 weeks of life (Y/N)

Time frame:
Assessed after patient death
Reported as:
Count of participants · Participants
Number of Participants Who Received Chemotherapy Within Last 2 Weeks of Life
ParticipantsWeb-based Advance Care Planning (PATIENTS)Facilitated Advance Care Planning (In-person or Telephonic) (PATIENTS)
Number of Participants Who Received Chemotherapy Within Last 2 Weeks of Life125
Statistical analysis
  • Web-based Advance Care Planning (PATIENTS) vs Facilitated Advance Care Planning (In-person or Telephonic) (PATIENTS) · Chi-squared · p = 0.07
Other pre-specifiedNumber of Participants Admitted to an Intensive Care Unit Within Last 30 Days of Life

Investigators will measure whether participant was admitted to the intensive care unit in the last 30 days of life (Y/N)

Time frame:
Assessed after patient death
Reported as:
Count of participants · Participants
Number of Participants Admitted to an Intensive Care Unit Within Last 30 Days of Life
ParticipantsWeb-based Advance Care Planning (PATIENTS)Facilitated Advance Care Planning (In-person or Telephonic) (PATIENTS)
Number of Participants Admitted to an Intensive Care Unit Within Last 30 Days of Life2016
Statistical analysis
  • Web-based Advance Care Planning (PATIENTS) vs Facilitated Advance Care Planning (In-person or Telephonic) (PATIENTS) · Chi-squared · p = 0.4
Other pre-specifiedNumber of Participants Admitted to Hospice Within Last 30 Days of Life

Investigators will measure whether the participant was admitted to hospice (Y/N)

Time frame:
Assessed after patient death
Reported as:
Count of participants · Participants
Number of Participants Admitted to Hospice Within Last 30 Days of Life
ParticipantsWeb-based Advance Care Planning (PATIENTS)Facilitated Advance Care Planning (In-person or Telephonic) (PATIENTS)
Number of Participants Admitted to Hospice Within Last 30 Days of Life6476
Statistical analysis
  • Web-based Advance Care Planning (PATIENTS) vs Facilitated Advance Care Planning (In-person or Telephonic) (PATIENTS) · Chi-squared · p = 0.19
Other pre-specifiedNumber of Participants Admitted to Hospice Within Last 3 Days of Life

Investigators will measure whether the participant was admitted to hospice for \< 3 days (Y/N)

Time frame:
Assessed after patient death
Reported as:
Count of participants · Participants
Number of Participants Admitted to Hospice Within Last 3 Days of Life
ParticipantsWeb-based Advance Care Planning (PATIENTS)Facilitated Advance Care Planning (In-person or Telephonic) (PATIENTS)
Number of Participants Admitted to Hospice Within Last 3 Days of Life1925
Statistical analysis
  • Web-based Advance Care Planning (PATIENTS) vs Facilitated Advance Care Planning (In-person or Telephonic) (PATIENTS) · Chi-squared · p = 0.38
Other pre-specifiedHealthcare Utilization at End of Life - Hospice Length of Stay

For participants admitted to hospice, investigators will measure number of days in hospice.

Time frame:
Assessed after patient death
Reported as:
Mean · days
Healthcare Utilization at End of Life - Hospice Length of Stay
daysWeb-based Advance Care Planning (PATIENTS)Facilitated Advance Care Planning (In-person or Telephonic) (PATIENTS)
Healthcare Utilization at End of Life - Hospice Length of Stay15.8 ± 19.727.8 ± 41.8
Statistical analysis
  • Web-based Advance Care Planning (PATIENTS) vs Facilitated Advance Care Planning (In-person or Telephonic) (PATIENTS) · Wilcoxon (Mann-Whitney) · p = 0.09
Other pre-specifiedNumber of Participants Who Were Hospitalized Within Last 30 Days of Life

Investigators will measure the number of participants hospitalized within in the last 30 days of life

Time frame:
Assess after patient death
Reported as:
Count of participants · Participants
Number of Participants Who Were Hospitalized Within Last 30 Days of Life
ParticipantsWeb-based Advance Care Planning (PATIENTS)Facilitated Advance Care Planning (In-person or Telephonic) (PATIENTS)
Number of Participants Who Were Hospitalized Within Last 30 Days of Life7467
Statistical analysis
  • Web-based Advance Care Planning (PATIENTS) vs Facilitated Advance Care Planning (In-person or Telephonic) (PATIENTS) · Chi-squared · p = 0.20
Other pre-specifiedNumber of Participants Who Had Emergency Department Visits Within Last 30 Days of Life

Investigators will measure number of emergency department visits in the last 30 days of life

Time frame:
Assessed after patient death
Reported as:
Count of participants · Participants
Number of Participants Who Had Emergency Department Visits Within Last 30 Days of Life
ParticipantsWeb-based Advance Care Planning (PATIENTS)Facilitated Advance Care Planning (In-person or Telephonic) (PATIENTS)
Number of Participants Who Had Emergency Department Visits Within Last 30 Days of Life6458
Statistical analysis
  • Web-based Advance Care Planning (PATIENTS) vs Facilitated Advance Care Planning (In-person or Telephonic) (PATIENTS) · Chi-squared · p = 0.28
Other pre-specifiedAdvance Care Planning Implementation Costs

Investigators will assess advance care planning implementation costs by tracking staff time spent on each intervention arm. Staff time costs for each intervention will be estimated by multiplying staff training and patient care time related to the intervention in hours by the average hourly wage for US nursing and social work staff of comparable levels.

Time frame:
through study completion, up to 5 years

Results for this outcome have not been posted.

Adverse events

Collected over up to 60 months. Non-serious events are listed at a 0% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Web-based Advance Care Planning (PATIENTS)112/203 (55.2%)0/203 (0%)0/203 (0%)
Facilitated Advance Care Planning (In-person or Telephonic) (PATIENTS)116/197 (58.9%)0/197 (0%)1/197 (0.5%)
Web-based Advance Care Planning (CAREGIVERS)0/133 (0%)0/133 (0%)0/133 (0%)
Facilitated Advance Care Planning (In-person or Telephonic) (CAREGIVERS)0/139 (0%)0/139 (0%)0/139 (0%)
Most frequent other events
Most frequent other events
EventWeb-based Advance Care Planning (PATIENTS)Facilitated Advance Care Planning (In-person or Telephonic) (PATIENTS)Web-based Advance Care Planning (CAREGIVERS)Facilitated Advance Care Planning (In-person or Telephonic) (CAREGIVERS)
Suicidal ideationPsychiatric disorders0/2031/1970/1330/139
Homicidal ideationPsychiatric disorders0/2031/1970/1330/139

Baseline characteristics

Some baseline measures were only collected for either patients or caregivers.

Age, Continuous
Age, Continuous(years)Web-based Advance Care Planning (PATIENTS)Facilitated Advance Care Planning (In-person or Telephonic) (PATIENTS)Web-based Advance Care Planning (CAREGIVERS)Facilitated Advance Care Planning (In-person or Telephonic) (CAREGIVERS)Total
Mean67.8 ± 1068.1 ± 1162.2 ± 13.661.9 ± 13.567.9 ± 10.5
Sex: Female, Male
Sex: Female, Male(Participants)Web-based Advance Care Planning (PATIENTS)Facilitated Advance Care Planning (In-person or Telephonic) (PATIENTS)Web-based Advance Care Planning (CAREGIVERS)Facilitated Advance Care Planning (In-person or Telephonic) (CAREGIVERS)Total
Female969696103391
Male1071013736281
Ethnicity (NIH/OMB)
Ethnicity (NIH/OMB)(Participants)Web-based Advance Care Planning (PATIENTS)Facilitated Advance Care Planning (In-person or Telephonic) (PATIENTS)Web-based Advance Care Planning (CAREGIVERS)Facilitated Advance Care Planning (In-person or Telephonic) (CAREGIVERS)Total
Hispanic or Latino13116
Not Hispanic or Latino201194132136663
Unknown or Not Reported10023
Race (NIH/OMB)
Race (NIH/OMB)(Participants)Web-based Advance Care Planning (PATIENTS)Facilitated Advance Care Planning (In-person or Telephonic) (PATIENTS)Web-based Advance Care Planning (CAREGIVERS)Facilitated Advance Care Planning (In-person or Telephonic) (CAREGIVERS)Total
American Indian or Alaska Native01012
Asian11114
Native Hawaiian or Other Pacific Islander00000
Black or African American17136541
White184181125132622
More than one race11103
Unknown or Not Reported00000
Region of Enrollment
Region of Enrollment(participants)Web-based Advance Care Planning (PATIENTS)Facilitated Advance Care Planning (In-person or Telephonic) (PATIENTS)Web-based Advance Care Planning (CAREGIVERS)Facilitated Advance Care Planning (In-person or Telephonic) (CAREGIVERS)Total
United States203197133139672
Education Level
Education Level(Participants)Web-based Advance Care Planning (PATIENTS)Facilitated Advance Care Planning (In-person or Telephonic) (PATIENTS)Web-based Advance Care Planning (CAREGIVERS)Facilitated Advance Care Planning (In-person or Telephonic) (CAREGIVERS)Total
< High school461314
High school diploma or GED66633436199
Some college or college degree107997469349
Graduate or professional degree25282431108
Refused to answer11002
Current Marital Status
Current Marital Status(Participants)Web-based Advance Care Planning (PATIENTS)Facilitated Advance Care Planning (In-person or Telephonic) (PATIENTS)Web-based Advance Care Planning (CAREGIVERS)Facilitated Advance Care Planning (In-person or Telephonic) (CAREGIVERS)Total
Never married161412648
Married125118105113461
Widowed28356978
Divorced/Separated282881074
Refused to answer50218
Unknown12003
Ability to manage on income
Ability to manage on income(Participants)Web-based Advance Care Planning (PATIENTS)Facilitated Advance Care Planning (In-person or Telephonic) (PATIENTS)Web-based Advance Care Planning (CAREGIVERS)Facilitated Advance Care Planning (In-person or Telephonic) (CAREGIVERS)Total
Cannot make ends meet628218
Just manage to get by51462124142
Have enough with a little extra59775854248
Money is not a problem56483541180
Refused to answer2724111880
Unknown40004

24 further baseline measures are reported on the registry.

08

Study locations

1 site
  • UPMC Hillman Cancer Center
    Pittsburgh, Pennsylvania 15232, United States
09

References and documents

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 41233979 ↗
  • Schenker 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 documents

  • Protocol and statistical analysis plan · Apr 17, 2024

Documents are hosted by the registry — open the source record to download them.

Individual participant data

Plan to share: No

10

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jan 14, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
11

Registry details

Key details

Study ID
NCT03824158
Lead sponsor
University of Pittsburgh
Collaborators
National Cancer Institute (NCI)
Responsible party
Yael Schenker, MD, MAS (Associate Professor, University of Pittsburgh) — Principal investigator
First posted
Jan 31, 2019
Start date
Aug 1, 2019
Primary completion
Jan 1, 2024
Completion
Jul 30, 2025
Results posted
Jan 17, 2025
Last update
Jan 14, 2026

Study contacts

Yael Schenker, MD, MPH
principal investigator · University of Pittsburgh

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Dec 2025. You cannot join it, but the record below documents what was studied.

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