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

Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03824158
• Other study ID #: STUDY19080337
• Secondary ID: 1R01CA235730-01
• Status: Active, not recruiting
• Phase: N/A
• Start date: August 1, 2019
• Est. completion date: June 2024

Study information

• Verified date: February 2024
• Source: University of Pittsburgh
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

Description:

Study investigators will conduct a single-blind, patient-level randomized trial to compare the effectiveness of two different patient-facing advance care planning (ACP) interventions. Investigators will enroll 400 patients with advanced cancer and their family caregivers to receive either (1) in-person discussions with trained facilitators or (2) web-based ACP using interactive videos. Because these approaches have never been compared directly, it is unclear whether one form of advance care planning is more potent, and if so, for whom and under what circumstances.

Aim 1 compares the effectiveness of in-person, facilitated ACP versus web-based ACP on patient and family caregiver outcomes (ACP engagement, ACP discussions, advance directive completion, goal attainment, and caregiver psychological symptoms). Aim 2 assesses implementation costs of each intervention and effects on healthcare utilization at end of life. Aim 3 identifies contexts and mechanisms influencing the effectiveness of each approach. Primary patient outcomes will be assessed at 12 weeks. Participants will be followed until 12 weeks after the patient's death or completion of the 48-month data collection period, whichever occurs first. In-depth interviews with patients, caregivers, and clinicians will begin in Year 2 of the grant and continue until thematic saturation is reached.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 700
• Est. completion date: June 2024
• Est. primary completion date: January 1, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Advance Care Planning
• Cancer

Intervention

Behavioral:
• 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.
• 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.

Locations

Country	Name	City	State
United States	UPMC Hillman Cancer Center	Pittsburgh	Pennsylvania

Sponsors (2)

Lead Sponsor	Collaborator
University of Pittsburgh	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Healthcare utilization at end of life - chemotherapy	Investigators will measure whether chemotherapy was administered within the last 2 weeks of life (Y/N)	during bereavement, up to 60 months
Other	Healthcare utilization at end of life - ICU	Investigators will measure whether participant was admitted to the intensive care unit in the last 30 days of life (Y/N)	during bereavement, up to 60 months
Other	Healthcare utilization at end of life - hospice	Investigators will measure whether the participant was admitted to hospice (Y/N)	during bereavement, up to 60 months
Other	Healthcare utilization at end of life - hospice < 3 days	Investigators will measure whether the participant was admitted to hospice for < 3 days (Y/N)	during bereavement, up to 60 months
Other	Healthcare utilization at end of life - hospice length of stay	For participants admitted to hospice, investigators will measure number of days in hospice.	during bereavement, up to 60 months
Other	Healthcare utilization at end of life - hospitalizations	Investigators will measure number of hospitalizations in the last month of life	during bereavement, up to 60 months
Other	Healthcare utilization at end of life - ED visits	Investigators will measure number of emergency department visits in the last month of life	during bereavement, up to 60 months
Other	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.	through study completion, up to 5 years
Primary	Advance care planning engagement	15-item ACP engagement survey assesses ACP processes related to choosing a medical decision maker, discussing and documenting preference for care at end of life, flexibility for surrogate decision making, and asking questions of medical providers. A single summary score will be reported (range 0-5 with higher scores indicating higher engagement).	12 weeks
Secondary	advance care planning discussions with caregivers	"Has [participant] talked with [participant's] family or friends about the kind of medical care [participant] would want if [participant] were very sick or near the end of life?"	12 weeks
Secondary	advance care planning discussions with physicians	"Has [participant] talked with [participant's] doctor about the kind of medical care [participant] would want if [participant] were very sick or near the end of life?"	12 weeks
Secondary	advance directive completion	"Has [participant] completed a living will or advance directive?"	12 weeks
Secondary	documented care goals	Investigators will assess documented care goals by reviewing medical records for any care goals documented since baseline (Yes/No).	12 weeks
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."	during bereavement, up to 60 months
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.	during bereavement, up to 60 months
Secondary	quality of end-of-life care	13-item Caregiver Evaluation of Quality of End-of-Life Care (CEQUEL) scale. A single summary score will be reported (range of scores 13-26, with higher scores indicating better perceived quality of care).	during bereavement, up to 60 months
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.	12 weeks and bereavement up to 60 months
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.	12 weeks and during bereavement, up to 60 months
Secondary	caregiver post-traumatic stress symptoms	22-item Impact of Events Scale-revised has a scoring range from 0-88, with higher scores indicating more post-traumatic stress symptoms.	during bereavement, up to 60 months