Advance Care Planning, Cancer
Conditions
Keywords
cancer, advance care planning
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.
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.
Sponsors
National Cancer Institute (NCI)
University of Pittsburgh
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 | 12 weeks | 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 | 12 weeks | 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. 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. |
| 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 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. |
| 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? |
Other
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants Admitted to Hospice Within Last 30 Days of Life | Assessed after patient death | Investigators will measure whether the participant was admitted to hospice (Y/N) |
| Number of Participants Admitted to Hospice Within Last 3 Days of Life | Assessed after patient death | Investigators will measure whether the participant was admitted to hospice for \< 3 days (Y/N) |
| Healthcare Utilization at End of Life - Hospice Length of Stay | Assessed after patient death | For participants admitted to hospice, investigators will measure number of days in hospice. |
| Number of Participants Who Were Hospitalized Within Last 30 Days of Life | Assess after patient death | Investigators will measure the number of participants hospitalized within in the last 30 days of life |
| Number of Participants Who Had Emergency Department Visits Within Last 30 Days of Life | Assessed after patient death | Investigators will measure number of emergency department visits in the last 30 days of life |
| Advance Care Planning Implementation Costs | through study completion, up to 5 years | 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. |
| Number of Participants Admitted to an Intensive Care Unit Within Last 30 Days of Life | Assessed after patient death | Investigators will measure whether participant was admitted to the intensive care unit in the last 30 days of life (Y/N) |
| Number of Participants Who Received Chemotherapy Within Last 2 Weeks of Life | Assessed after patient death | Investigators will measure whether chemotherapy was administered within the last 2 weeks of life (Y/N) |
Countries
United States
Participant flow
Recruitment details
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.
Participants by arm
| Arm | Count |
|---|---|
| Web-based Advance Care Planning (PATIENTS) Patients randomized to this arm will participate in web-based ACP via the PREPARE website.
Web-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. | 203 |
| Facilitated Advance Care Planning (In-person or Telephonic) (PATIENTS) Patients randomized to this arm will participate in in-person or telephonic facilitated advance care planning (ACP) discussions using the Respecting Choices model.
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. | 197 |
| Web-based Advance Care Planning (CAREGIVERS) Enrolled caregivers of patients randomized to the web-based advance care planning arm. | 133 |
| Facilitated Advance Care Planning (In-person or Telephonic) (CAREGIVERS) Enrolled caregivers of patients randomized to the facilitated advance care planning arm. | 139 |
| Total | 672 |
Baseline characteristics
| Characteristic | Facilitated Advance Care Planning (In-person or Telephonic) (CAREGIVERS) | Web-based Advance Care Planning (CAREGIVERS) | Facilitated Advance Care Planning (In-person or Telephonic) (PATIENTS) | Web-based Advance Care Planning (PATIENTS) | Total |
|---|---|---|---|---|---|
| Ability to manage on income Cannot make ends meet | 2 Participants | 8 Participants | 2 Participants | 6 Participants | 18 Participants |
| Ability to manage on income Have enough with a little extra | 54 Participants | 58 Participants | 77 Participants | 59 Participants | 248 Participants |
| Ability to manage on income Just manage to get by | 24 Participants | 21 Participants | 46 Participants | 51 Participants | 142 Participants |
| Ability to manage on income Money is not a problem | 41 Participants | 35 Participants | 48 Participants | 56 Participants | 180 Participants |
| Ability to manage on income Refused to answer | 18 Participants | 11 Participants | 24 Participants | 27 Participants | 80 Participants |
| Ability to manage on income Unknown | 0 Participants | 0 Participants | 0 Participants | 4 Participants | 4 Participants |
| Advance Care Planning (ACP) Engagement Survey Total Scores | — | — | 3.74 score on a scale STANDARD_DEVIATION 1.02 | 3.66 score on a scale STANDARD_DEVIATION 0.93 | 3.70 score on a scale STANDARD_DEVIATION 0.98 |
| Age, Continuous | 61.9 years STANDARD_DEVIATION 13.5 | 62.2 years STANDARD_DEVIATION 13.6 | 68.1 years STANDARD_DEVIATION 11 | 67.8 years STANDARD_DEVIATION 10 | 67.9 years STANDARD_DEVIATION 10.5 |
| Average days per week providing care | 5.59 days per week STANDARD_DEVIATION 2.3 | 5.33 days per week STANDARD_DEVIATION 2.3 | — | — | 5.46 days per week STANDARD_DEVIATION 2.3 |
| Average hours per day providing care | 7.15 hours per day STANDARD_DEVIATION 7.9 | 6.92 hours per day STANDARD_DEVIATION 8.1 | — | — | 7.03 hours per day STANDARD_DEVIATION 8 |
| Cancer type Brain | — | — | 0 Participants | 1 Participants | 1 Participants |
| Cancer type Breast | — | — | 31 Participants | 18 Participants | 49 Participants |
| Cancer type Gastrointestinal | — | — | 38 Participants | 39 Participants | 77 Participants |
| Cancer type Genitourinary | — | — | 20 Participants | 21 Participants | 41 Participants |
| Cancer type Gynecologic | — | — | 12 Participants | 7 Participants | 19 Participants |
| Cancer type Head and Neck | — | — | 10 Participants | 10 Participants | 20 Participants |
| Cancer type Hepatobiliary | — | — | 8 Participants | 9 Participants | 17 Participants |
| Cancer type Lung | — | — | 34 Participants | 48 Participants | 82 Participants |
| Cancer type Melanoma | — | — | 0 Participants | 1 Participants | 1 Participants |
| Cancer type Other | — | — | 4 Participants | 6 Participants | 10 Participants |
| Cancer type Pancreatic | — | — | 22 Participants | 20 Participants | 42 Participants |
| Cancer type Prostate | — | — | 18 Participants | 23 Participants | 41 Participants |
| Caregiver lives with the patient | 94 Participants | 98 Participants | — | — | 192 Participants |
| Confidence filling out medical forms A little bit | 3 Participants | 4 Participants | 9 Participants | 9 Participants | 25 Participants |
| Confidence filling out medical forms Extremely | 85 Participants | 81 Participants | 91 Participants | 94 Participants | 351 Participants |
| Confidence filling out medical forms Not at all | 3 Participants | 1 Participants | 7 Participants | 6 Participants | 17 Participants |
| Confidence filling out medical forms Quite a bit | 33 Participants | 31 Participants | 47 Participants | 40 Participants | 151 Participants |
| Confidence filling out medical forms Somewhat | 15 Participants | 16 Participants | 43 Participants | 54 Participants | 128 Participants |
| Current care provider for the patient | 124 Participants | 117 Participants | — | — | 241 Participants |
| Current employment status Disability | 6 Participants | 4 Participants | 22 Participants | 24 Participants | 56 Participants |
| Current employment status Homemaker (never worked for pay) | 3 Participants | 5 Participants | 4 Participants | 1 Participants | 13 Participants |
| Current employment status Other | 7 Participants | 10 Participants | 11 Participants | 16 Participants | 44 Participants |
| Current employment status Refused to answer | 1 Participants | 1 Participants | 3 Participants | 6 Participants | 11 Participants |
| Current employment status Retired | 62 Participants | 59 Participants | 120 Participants | 118 Participants | 359 Participants |
| Current employment status Unemployed | 2 Participants | 3 Participants | 9 Participants | 11 Participants | 25 Participants |
| Current employment status Working full-time | 46 Participants | 40 Participants | 21 Participants | 20 Participants | 127 Participants |
| Current employment status Working part-time | 12 Participants | 11 Participants | 7 Participants | 7 Participants | 37 Participants |
| Current living situation In a Board and Care home | — | — | 0 Participants | 0 Participants | 0 Participants |
| Current living situation In a home I (or my family) own | — | — | 155 Participants | 161 Participants | 316 Participants |
| Current living situation In a home I (or my family) rent | — | — | 28 Participants | 31 Participants | 59 Participants |
| Current living situation In an Assisted Living Facility | — | — | 3 Participants | 2 Participants | 5 Participants |
| Current living situation In a Nursing Home | — | — | 3 Participants | 0 Participants | 3 Participants |
| Current living situation Other/Unsure | — | — | 8 Participants | 6 Participants | 14 Participants |
| Current living situation Refused to answer | — | — | 0 Participants | 3 Participants | 3 Participants |
| Currently providing care for anyone else | 31 Participants | 29 Participants | — | — | 60 Participants |
| Current Marital Status Divorced/Separated | 10 Participants | 8 Participants | 28 Participants | 28 Participants | 74 Participants |
| Current Marital Status Married | 113 Participants | 105 Participants | 118 Participants | 125 Participants | 461 Participants |
| Current Marital Status Never married | 6 Participants | 12 Participants | 14 Participants | 16 Participants | 48 Participants |
| Current Marital Status Refused to answer | 1 Participants | 2 Participants | 0 Participants | 5 Participants | 8 Participants |
| Current Marital Status Unknown | 0 Participants | 0 Participants | 2 Participants | 1 Participants | 3 Participants |
| Current Marital Status Widowed | 9 Participants | 6 Participants | 35 Participants | 28 Participants | 78 Participants |
| ECOG Performance Status ECOG Score - 0 | — | — | 68 Participants | 64 Participants | 132 Participants |
| ECOG Performance Status ECOG Score - 1 | — | — | 102 Participants | 122 Participants | 224 Participants |
| ECOG Performance Status ECOG Score - 2 | — | — | 27 Participants | 17 Participants | 44 Participants |
| Education Level Graduate or professional degree | 31 Participants | 24 Participants | 28 Participants | 25 Participants | 108 Participants |
| Education Level < High school | 3 Participants | 1 Participants | 6 Participants | 4 Participants | 14 Participants |
| Education Level High school diploma or GED | 36 Participants | 34 Participants | 63 Participants | 66 Participants | 199 Participants |
| Education Level Refused to answer | 0 Participants | 0 Participants | 1 Participants | 1 Participants | 2 Participants |
| Education Level Some college or college degree | 69 Participants | 74 Participants | 99 Participants | 107 Participants | 349 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 1 Participants | 1 Participants | 3 Participants | 1 Participants | 6 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 136 Participants | 132 Participants | 194 Participants | 201 Participants | 663 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 2 Participants | 0 Participants | 0 Participants | 1 Participants | 3 Participants |
| HADS Survey Anxiety Subscale Scores | 7.44 score on a scale STANDARD_DEVIATION 4.43 | 7.0 score on a scale STANDARD_DEVIATION 4.1 | 5.15 score on a scale STANDARD_DEVIATION 3.73 | 5.22 score on a scale STANDARD_DEVIATION 3.69 | 5.19 score on a scale STANDARD_DEVIATION 3.71 |
| HADS Survey Depression Subscale Scores | 3.96 score on a scale STANDARD_DEVIATION 3.43 | 4.22 score on a scale STANDARD_DEVIATION 3.54 | 4.69 score on a scale STANDARD_DEVIATION 3.52 | 4.62 score on a scale STANDARD_DEVIATION 3.44 | 4.65 score on a scale STANDARD_DEVIATION 3.48 |
| How many other people live in your household? 0 | 10 Participants | 7 Participants | 49 Participants | 45 Participants | 111 Participants |
| How many other people live in your household? 1 | 95 Participants | 90 Participants | 110 Participants | 112 Participants | 407 Participants |
| How many other people live in your household? 2 | 17 Participants | 17 Participants | 24 Participants | 26 Participants | 84 Participants |
| How many other people live in your household? 3 | 14 Participants | 14 Participants | 12 Participants | 14 Participants | 54 Participants |
| How many other people live in your household? 4+ | 3 Participants | 5 Participants | 1 Participants | 4 Participants | 13 Participants |
| How many other people live in your household? Unknown | 0 Participants | 0 Participants | 1 Participants | 2 Participants | 3 Participants |
| Patient reported previously completing a living will or advance directive | — | — | 103 Participants | 95 Participants | 198 Participants |
| Patient reported previously having advance care planning discussions with caregivers | — | — | 136 Participants | 139 Participants | 275 Participants |
| Patient reported previously having advance care planning discussions with physicians | — | — | 53 Participants | 48 Participants | 101 Participants |
| Prior living will or advance directive in the medical record | — | — | 27 Participants | 24 Participants | 51 Participants |
| Prior POLST form in the medical record | — | — | 8 Participants | 4 Participants | 12 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 1 Participants | 0 Participants | 1 Participants | 0 Participants | 2 Participants |
| Race (NIH/OMB) Asian | 1 Participants | 1 Participants | 1 Participants | 1 Participants | 4 Participants |
| Race (NIH/OMB) Black or African American | 5 Participants | 6 Participants | 13 Participants | 17 Participants | 41 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 1 Participants | 1 Participants | 1 Participants | 3 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 132 Participants | 125 Participants | 181 Participants | 184 Participants | 622 Participants |
| Region of Enrollment United States | 139 participants | 133 participants | 197 participants | 203 participants | 672 participants |
| Relationship to enrolled patient Child | 24 Participants | 25 Participants | — | — | 49 Participants |
| Relationship to enrolled patient Friend | 5 Participants | 2 Participants | — | — | 7 Participants |
| Relationship to enrolled patient Other | 9 Participants | 4 Participants | — | — | 13 Participants |
| Relationship to enrolled patient Parent | 4 Participants | 5 Participants | — | — | 9 Participants |
| Relationship to enrolled patient Refused to answer | 0 Participants | 1 Participants | — | — | 1 Participants |
| Relationship to enrolled patient Sibling | 12 Participants | 6 Participants | — | — | 18 Participants |
| Relationship to enrolled patient Spouse/partner | 85 Participants | 90 Participants | — | — | 175 Participants |
| Religion Agnostic/Atheist/No religion | 9 Participants | 5 Participants | 14 Participants | 8 Participants | 36 Participants |
| Religion Buddhist | 0 Participants | 0 Participants | 0 Participants | 1 Participants | 1 Participants |
| Religion Catholic | 56 Participants | 57 Participants | 72 Participants | 91 Participants | 276 Participants |
| Religion Declined to answer | 8 Participants | 9 Participants | 16 Participants | 18 Participants | 51 Participants |
| Religion Hindu | 1 Participants | 0 Participants | 1 Participants | 0 Participants | 2 Participants |
| Religion Jewish | 4 Participants | 3 Participants | 5 Participants | 3 Participants | 15 Participants |
| Religion Muslim | 0 Participants | 1 Participants | 0 Participants | 0 Participants | 1 Participants |
| Religion Other | 14 Participants | 13 Participants | 14 Participants | 15 Participants | 56 Participants |
| Religion Other Christian | 19 Participants | 12 Participants | 27 Participants | 24 Participants | 82 Participants |
| Religion Protestant | 28 Participants | 33 Participants | 48 Participants | 42 Participants | 151 Participants |
| Religion Unknown | 0 Participants | 0 Participants | 0 Participants | 1 Participants | 1 Participants |
| Religious importance Fairly important | 43 Participants | 39 Participants | 43 Participants | 53 Participants | 178 Participants |
| Religious importance Not at all important | 8 Participants | 2 Participants | 20 Participants | 9 Participants | 39 Participants |
| Religious importance Not too important | 21 Participants | 17 Participants | 25 Participants | 24 Participants | 87 Participants |
| Religious importance Refused to answer | 3 Participants | 7 Participants | 7 Participants | 10 Participants | 27 Participants |
| Religious importance Unknown | 0 Participants | 0 Participants | 1 Participants | 1 Participants | 2 Participants |
| Religious importance Very important | 64 Participants | 68 Participants | 101 Participants | 106 Participants | 339 Participants |
| Sex: Female, Male Female | 103 Participants | 96 Participants | 96 Participants | 96 Participants | 391 Participants |
| Sex: Female, Male Male | 36 Participants | 37 Participants | 101 Participants | 107 Participants | 281 Participants |
| Time receiving care from current oncologist ≥ 1 month but < 6 months | — | — | 36 Participants | 40 Participants | 76 Participants |
| Time receiving care from current oncologist ≥ 1 year but < 2 years | — | — | 29 Participants | 35 Participants | 64 Participants |
| Time receiving care from current oncologist ≥ 2 years but < 5 years | — | — | 39 Participants | 41 Participants | 80 Participants |
| Time receiving care from current oncologist ≥ 5 years | — | — | 31 Participants | 23 Participants | 54 Participants |
| Time receiving care from current oncologist ≥ 6 months but < 1 year | — | — | 51 Participants | 48 Participants | 99 Participants |
| Time receiving care from current oncologist Less than one month | — | — | 11 Participants | 13 Participants | 24 Participants |
| Time receiving care from current oncologist Refused to answer | — | — | 0 Participants | 3 Participants | 3 Participants |
| Time since first diagnosed with cancer ≥ 1 month but < 6 months ago | — | — | 31 Participants | 27 Participants | 58 Participants |
| Time since first diagnosed with cancer ≥ 1 year but < 2 years ago | — | — | 23 Participants | 31 Participants | 54 Participants |
| Time since first diagnosed with cancer ≥ 2 years but < 5 years ago | — | — | 39 Participants | 36 Participants | 75 Participants |
| Time since first diagnosed with cancer ≥ 5 years ago | — | — | 53 Participants | 49 Participants | 102 Participants |
| Time since first diagnosed with cancer ≥ 6 months but < 1 year ago | — | — | 43 Participants | 44 Participants | 87 Participants |
| Time since first diagnosed with cancer Less than one month ago | — | — | 6 Participants | 11 Participants | 17 Participants |
| Time since first diagnosed with cancer Refused to answer | — | — | 2 Participants | 4 Participants | 6 Participants |
| Time since first diagnosed with cancer Unknown | — | — | 0 Participants | 1 Participants | 1 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk |
|---|---|---|---|---|
| deaths Total, all-cause mortality | 112 / 203 | 116 / 197 | 0 / 133 | 0 / 139 |
| other Total, other adverse events | 0 / 203 | 1 / 197 | 0 / 133 | 0 / 139 |
| serious Total, serious adverse events | 0 / 203 | 0 / 197 | 0 / 133 | 0 / 139 |
Outcome results
Primary
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
Population: Number of participants that completed 12 week outcomes assessment.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Web-based Advance Care Planning (PATIENTS) | Advance Care Planning Engagement | 4.08 score on a scale | Standard Deviation 0.82 |
| Facilitated Advance Care Planning (In-person or Telephonic) (PATIENTS) | Advance Care Planning Engagement | 4.34 score on a scale | Standard Deviation 0.78 |
p-value: 0.0014Mixed Models Analysis
Secondary
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
Population: Bereaved caregivers
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Web-based Advance Care Planning (PATIENTS) | Caregiver Anxiety Symptoms | 6.72 score on a scale | Standard Deviation 4.59 |
| Facilitated Advance Care Planning (In-person or Telephonic) (PATIENTS) | Caregiver Anxiety Symptoms | 6.56 score on a scale | Standard Deviation 3.32 |
p-value: 0.84t-test, 2 sided
Secondary
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
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Web-based Advance Care Planning (PATIENTS) | Caregiver Anxiety Symptoms | 6.94 score on a scale | Standard Deviation 4.6 |
| Facilitated Advance Care Planning (In-person or Telephonic) (PATIENTS) | Caregiver Anxiety Symptoms | 6.5 score on a scale | Standard Deviation 3.92 |
p-value: 0.11Mixed Models Analysis
Secondary
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
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Web-based Advance Care Planning (PATIENTS) | Caregiver Depression Symptoms | 4.34 score on a scale | Standard Deviation 4.07 |
| Facilitated Advance Care Planning (In-person or Telephonic) (PATIENTS) | Caregiver Depression Symptoms | 3.69 score on a scale | Standard Deviation 3.57 |
p-value: 0.17Mixed Models Analysis
Secondary
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
Population: Bereaved caregivers
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Web-based Advance Care Planning (PATIENTS) | Caregiver Depression Symptoms | 5.87 score on a scale | Standard Deviation 4.11 |
| Facilitated Advance Care Planning (In-person or Telephonic) (PATIENTS) | Caregiver Depression Symptoms | 5.34 score on a scale | Standard Deviation 6.56 |
p-value: 0.5t-test, 2 sided
Secondary
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
Population: Bereaved caregivers
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Web-based Advance Care Planning (PATIENTS) | Caregiver Post-traumatic Stress Symptoms | Avoidance subscale | 1.15 score on a scale | Standard Deviation 0.64 |
| Web-based Advance Care Planning (PATIENTS) | Caregiver Post-traumatic Stress Symptoms | Hyperarousal Subscale | 1.06 score on a scale | Standard Deviation 0.84 |
| Web-based Advance Care Planning (PATIENTS) | Caregiver Post-traumatic Stress Symptoms | Intrusions Subscale | 1.99 score on a scale | Standard Deviation 0.89 |
| Web-based Advance Care Planning (PATIENTS) | Caregiver Post-traumatic Stress Symptoms | IES-R Total Score | 31.5 score on a scale | Standard Deviation 15.2 |
| Facilitated Advance Care Planning (In-person or Telephonic) (PATIENTS) | Caregiver Post-traumatic Stress Symptoms | Intrusions Subscale | 1.48 score on a scale | Standard Deviation 0.86 |
| Facilitated Advance Care Planning (In-person or Telephonic) (PATIENTS) | Caregiver Post-traumatic Stress Symptoms | Avoidance subscale | 0.96 score on a scale | Standard Deviation 0.79 |
| Facilitated Advance Care Planning (In-person or Telephonic) (PATIENTS) | Caregiver Post-traumatic Stress Symptoms | IES-R Total Score | 23.9 score on a scale | Standard Deviation 14.6 |
| Facilitated Advance Care Planning (In-person or Telephonic) (PATIENTS) | Caregiver Post-traumatic Stress Symptoms | Hyperarousal Subscale | 0.74 score on a scale | Standard Deviation 0.64 |
Comparison: IES-R Total Score p-valuep-value: 0.01t-test, 2 sided
Secondary
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
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Web-based Advance Care Planning (PATIENTS) | Documented Care Goals | New advance directive or living will | 4 participants |
| Web-based Advance Care Planning (PATIENTS) | Documented Care Goals | New Physician Orders for Life-sustaining Treatment (POLST) form | 1 participants |
| Web-based Advance Care Planning (PATIENTS) | Documented Care Goals | New Code Status | 29 participants |
| Web-based Advance Care Planning (PATIENTS) | Documented Care Goals | New Goals of Care discussion | 26 participants |
| Facilitated Advance Care Planning (In-person or Telephonic) (PATIENTS) | Documented Care Goals | New Goals of Care discussion | 22 participants |
| Facilitated Advance Care Planning (In-person or Telephonic) (PATIENTS) | Documented Care Goals | New advance directive or living will | 18 participants |
| Facilitated Advance Care Planning (In-person or Telephonic) (PATIENTS) | Documented Care Goals | New Code Status | 31 participants |
| Facilitated Advance Care Planning (In-person or Telephonic) (PATIENTS) | Documented Care Goals | New Physician Orders for Life-sustaining Treatment (POLST) form | 8 participants |
Comparison: Advance directive or living willp-value: 0.002Chi-squared
Comparison: POLSTp-value: 0.02Fisher Exact
Comparison: Code Statusp-value: 0.78Chi-squared
Comparison: Goals of Care discussionp-value: 0.61Chi-squared
Secondary
Number of Participants Who Have Completed an Advance Directive
Has \[participant\] completed a living will or advance directive?
Time frame: 12 weeks
Population: Number of participants that completed 12 week outcomes assessment.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Web-based Advance Care Planning (PATIENTS) | Number of Participants Who Have Completed an Advance Directive | 80 Participants |
| Facilitated Advance Care Planning (In-person or Telephonic) (PATIENTS) | Number of Participants Who Have Completed an Advance Directive | 101 Participants |
p-value: 0.008Mixed Models Analysis
Secondary
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
Population: Number of participants that completed 12 week outcomes assessment.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Web-based Advance Care Planning (PATIENTS) | Number of Participants Who Have Had Advance Care Planning Discussions With Caregivers | 117 Participants |
| Facilitated Advance Care Planning (In-person or Telephonic) (PATIENTS) | Number of Participants Who Have Had Advance Care Planning Discussions With Caregivers | 120 Participants |
p-value: 0.76Regression, Logistic
Secondary
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
Population: Number of participants that completed 12 week outcomes assessment.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Web-based Advance Care Planning (PATIENTS) | Number of Participants Who Have Had Advance Care Planning Discussions With Physicians | 54 Participants |
| Facilitated Advance Care Planning (In-person or Telephonic) (PATIENTS) | Number of Participants Who Have Had Advance Care Planning Discussions With Physicians | 67 Participants |
p-value: 0.13Mixed Models Analysis
Secondary
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
Population: Bereaved caregivers
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Web-based Advance Care Planning (PATIENTS) | Quality of End-of-life Care | Perceived Suffering Subscale | 5.51 score on a scale | Standard Deviation 0.83 |
| Web-based Advance Care Planning (PATIENTS) | Quality of End-of-life Care | Preparation for the Death subscale | 5.66 score on a scale | Standard Deviation 0.72 |
| Web-based Advance Care Planning (PATIENTS) | Quality of End-of-life Care | Shared Decision-Making subscale | 7.67 score on a scale | Standard Deviation 0.74 |
| Web-based Advance Care Planning (PATIENTS) | Quality of End-of-life Care | Total Score | 24.45 score on a scale | Standard Deviation 2.05 |
| Web-based Advance Care Planning (PATIENTS) | Quality of End-of-life Care | Prolongation of Death subscale | 5.62 score on a scale | Standard Deviation 0.78 |
| Facilitated Advance Care Planning (In-person or Telephonic) (PATIENTS) | Quality of End-of-life Care | Total Score | 24.35 score on a scale | Standard Deviation 1.83 |
| Facilitated Advance Care Planning (In-person or Telephonic) (PATIENTS) | Quality of End-of-life Care | Prolongation of Death subscale | 5.69 score on a scale | Standard Deviation 0.62 |
| Facilitated Advance Care Planning (In-person or Telephonic) (PATIENTS) | Quality of End-of-life Care | Perceived Suffering Subscale | 5.45 score on a scale | Standard Deviation 0.91 |
| Facilitated Advance Care Planning (In-person or Telephonic) (PATIENTS) | Quality of End-of-life Care | Shared Decision-Making subscale | 7.7 score on a scale | Standard Deviation 0.68 |
| Facilitated Advance Care Planning (In-person or Telephonic) (PATIENTS) | Quality of End-of-life Care | Preparation for the Death subscale | 5.51 score on a scale | Standard Deviation 0.72 |
p-value: 0.32Wilcoxon (Mann-Whitney)
Secondary
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
Population: Bereaved caregivers
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Web-based Advance Care Planning (PATIENTS) | Receipt of Goal-concordant End-of-life Care - Patient Wishes Followed | A great deal | 37 Participants |
| Web-based Advance Care Planning (PATIENTS) | Receipt of Goal-concordant End-of-life Care - Patient Wishes Followed | Somewhat | 11 Participants |
| Web-based Advance Care Planning (PATIENTS) | Receipt of Goal-concordant End-of-life Care - Patient Wishes Followed | Not at all | 1 Participants |
| Web-based Advance Care Planning (PATIENTS) | Receipt of Goal-concordant End-of-life Care - Patient Wishes Followed | Did not answer | 1 Participants |
| Facilitated Advance Care Planning (In-person or Telephonic) (PATIENTS) | Receipt of Goal-concordant End-of-life Care - Patient Wishes Followed | Did not answer | 0 Participants |
| Facilitated Advance Care Planning (In-person or Telephonic) (PATIENTS) | Receipt of Goal-concordant End-of-life Care - Patient Wishes Followed | A great deal | 46 Participants |
| Facilitated Advance Care Planning (In-person or Telephonic) (PATIENTS) | Receipt of Goal-concordant End-of-life Care - Patient Wishes Followed | Not at all | 0 Participants |
| Facilitated Advance Care Planning (In-person or Telephonic) (PATIENTS) | Receipt of Goal-concordant End-of-life Care - Patient Wishes Followed | Somewhat | 2 Participants |
p-value: 0.01Fisher Exact
Secondary
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
Population: Bereaved caregivers
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Web-based Advance Care Planning (PATIENTS) | Receipt of Goal-concordant End-of-life Care - Place of Death | 34 Participants |
| Facilitated Advance Care Planning (In-person or Telephonic) (PATIENTS) | Receipt of Goal-concordant End-of-life Care - Place of Death | 37 Participants |
p-value: 0.83Fisher Exact
Other Pre-specified
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
Other Pre-specified
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
Population: Deceased patients
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Web-based Advance Care Planning (PATIENTS) | Healthcare Utilization at End of Life - Hospice Length of Stay | 15.8 days | Standard Deviation 19.7 |
| Facilitated Advance Care Planning (In-person or Telephonic) (PATIENTS) | Healthcare Utilization at End of Life - Hospice Length of Stay | 27.8 days | Standard Deviation 41.8 |
p-value: 0.09Wilcoxon (Mann-Whitney)
Other Pre-specified
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
Population: Deceased patients
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Web-based Advance Care Planning (PATIENTS) | Number of Participants Admitted to an Intensive Care Unit Within Last 30 Days of Life | 20 Participants |
| Facilitated Advance Care Planning (In-person or Telephonic) (PATIENTS) | Number of Participants Admitted to an Intensive Care Unit Within Last 30 Days of Life | 16 Participants |
p-value: 0.4Chi-squared
Other Pre-specified
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
Population: Deceased patients
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Web-based Advance Care Planning (PATIENTS) | Number of Participants Admitted to Hospice Within Last 30 Days of Life | 64 Participants |
| Facilitated Advance Care Planning (In-person or Telephonic) (PATIENTS) | Number of Participants Admitted to Hospice Within Last 30 Days of Life | 76 Participants |
p-value: 0.19Chi-squared
Other Pre-specified
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
Population: Deceased patients
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Web-based Advance Care Planning (PATIENTS) | Number of Participants Admitted to Hospice Within Last 3 Days of Life | 19 Participants |
| Facilitated Advance Care Planning (In-person or Telephonic) (PATIENTS) | Number of Participants Admitted to Hospice Within Last 3 Days of Life | 25 Participants |
p-value: 0.38Chi-squared
Other Pre-specified
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
Population: Deceased patients
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Web-based Advance Care Planning (PATIENTS) | Number of Participants Who Had Emergency Department Visits Within Last 30 Days of Life | 64 Participants |
| Facilitated Advance Care Planning (In-person or Telephonic) (PATIENTS) | Number of Participants Who Had Emergency Department Visits Within Last 30 Days of Life | 58 Participants |
p-value: 0.28Chi-squared
Other Pre-specified
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
Population: Deceased patients
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Web-based Advance Care Planning (PATIENTS) | Number of Participants Who Received Chemotherapy Within Last 2 Weeks of Life | 12 Participants |
| Facilitated Advance Care Planning (In-person or Telephonic) (PATIENTS) | Number of Participants Who Received Chemotherapy Within Last 2 Weeks of Life | 5 Participants |
p-value: 0.07Chi-squared
Other Pre-specified
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
Population: Deceased patients
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Web-based Advance Care Planning (PATIENTS) | Number of Participants Who Were Hospitalized Within Last 30 Days of Life | 74 Participants |
| Facilitated Advance Care Planning (In-person or Telephonic) (PATIENTS) | Number of Participants Who Were Hospitalized Within Last 30 Days of Life | 67 Participants |
p-value: 0.2Chi-squared