Other CancerACP-PEACENCT03609177
Advance Care Planning: Promoting Effective and Aligned Communication in the Elderly
A study testing Clinician Communication Skills Training, Advance Care Planning (ACP) Decisions Videos Decisions Aids and Video Declarations (ViDec) in people with Other Cancer, run by Dana-Farber Cancer Institute at 4 sites in United States.
Trial summary
In this research study, the investigators are working to help oncologists better serve patients by delivering more patient-centered, goal-concordant care that may improve health care delivery. Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Other Cancer
- What is being tested?
- Clinician Communication Skills Training, Advance Care Planning (ACP) Decisions Videos Decisions Aids and Video Declarations (ViDec)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 13,800 participants
- Where
- 4 sitesUnited States
- Study dates
- 15 Apr 2020to 30 Sep 2024
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- Clinic eligibility criteria include:
- More than one oncologist
- Serve a patient population that is at least 30% aged 65 or older
- Disease-based oncology clinic
- Subject Eligibility: (for the in-person surveys):
- Any patient affiliated with one of the study clinics who speaks English and is aged 65 or older with advanced cancer is eligible for participation. Advanced cancer is defined as metastatic disease for solid tumors and recurrent or refractory disease for hematological malignancies. There are no exclusions based on gender, race, or ethnicity.
Who cannot join
- Adults unable to consent
- Individuals who are not yet adults (infants, children, teenagers)
- Pregnant women
- Prisoners
Trial locations and contacts
4 sites in 1 country.
United States4 sites
Dana Farber Cancer Institute
Boston, Massachusetts, 02215
Duke Health
Durham, North Carolina, 27710
Northwell Health
New Hyde Park, New York, 11040
Mayo Clinic
Rochester, Minnesota, 55905
About this study
Official title: Improving Advance Care Planning in Oncology: A Pragmatic, Cluster-Randomized Trial Integrating Patient Videos and Clinician Communication Training
In this research study, the investigators are working to help oncologists better serve patients by delivering more patient-centered, goal-concordant care that may improve health care delivery.
- It is expected that about 30,000 people will take part in this research study, 29,550 of these patients, the vast majority, will be included only for medical record review.
Read the detailed description
The purpose of this study is to improve the quality of care provided to millions of older Americans with cancer. The investigators are working to help oncologists better serve patients by delivering more patient-centered, goal-concordant care that may dramatically improve health care delivery.
This is pragmatic stepped wedge cluster randomized trial (SW-CRT) of a Comprehensive ACP (Advance Care Planning) Program among older oncology patients. The ACP Program will include training clinicians in communication skills and using video decision aids for participants.
- This study will involve medical record review of 30,000 people age 65 or older with advanced cancer.
We will also recruit 450 eligible patients (150 patients from each of our three sites broken down into 75 patients during the control phase and 75 patients during the intervention phase) to conduct a survey for our secondary patient-centered outcomes (confidence, satisfaction with physician communication, patient decisional satisfaction and regret). From among this sub-group we will engage 240 participants (80 from each of our three sites broken down into 40 patients during the control phase and 40 patients during the intervention phase) in an activity to film video declarations of their preferences.
During the first year, three pilot sites (one at each health care system) will trial the intervention. The subjects recruited at these pilot sites will not be included in the final analysis. Thus, the main trial will begin during year 2 and continue through year 5 with recruitment of 30,000 subjects for the primary outcome at 30 oncology clinics. The first year pilot will serve to inform the larger roll-out and the intervention may change during the first year based on pilot-clinic experience.
- Conditions
- Other Cancer
- Being tested
- Clinician Communication Skills Training, Advance Care Planning (ACP) Decisions Videos Decisions Aids, Video Declarations (ViDec)
- Keywords
- Cancer Care
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Clinician Communication Skills TrainingOther
Also called Vital Talk Communication Skills Training
Communication skills training
Advance Care Planning (ACP) Decisions Videos Decisions AidsOther
ACP Decisions video decision aids
Video Declarations (ViDec)Other
Recording of patient advance care planning videos
| Study group | Role | What they receive |
|---|---|---|
| Advance Care Planning | Experimental | -Survey:
* A group of older patients with advanced cancer (N=450) will have a survey over the course of the 36 months of recruitment.
* Participants will be provided written copies of the questions to follow along during the interviews Receives: Other: Clinician Communication Skills Training; Other: Advance Care Planning (ACP) Decisions Videos Decisions Aids |
| Advance Care Planning-Video Declaration | Experimental | Video Declaration:
* From among this group of 450 participants, the video declaration of preferences activity will be conducted with 240 patients.
* For those participants that agree to the video declaration, they will proceed with recording of their video declarations
* The RA will begin by reading a standardized introduction to aid the subject do the video Receives: Other: Clinician Communication Skills Training; Other: Advance Care Planning (ACP) Decisions Videos Decisions Aids; Other: Video Declarations (ViDec) |
| Comprehensive Record Review of ACP | Other | * A review of Medical orders for resuscitation preferences in the electronic health record
* A review of Medical orders for Palliative care consultations preferences in the electronic health record
* A review of Medical orders for Hospice use preferences in the electronic health record Receives: Other: Clinician Communication Skills Training; Other: Advance Care Planning (ACP) Decisions Videos Decisions Aids; Other: Video Declarations (ViDec) |
| Main Study Arm | Experimental | Patients with cancer being seen at the 30 oncology clinics will be exposed to clinicians who have had communication skills training (Vital Talk) and who are using video decision aids (ACP Decisions). Our main outcome is advance care planning documentation. Receives: Other: Clinician Communication Skills Training; Other: Advance Care Planning (ACP) Decisions Videos Decisions Aids; Other: Video Declarations (ViDec) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants With Advance Care Planning Documentation
Any advance directive (e.g., living will, POLST, etc.) and changes of resuscitation orders or any indication in the EHR of a goals-of-care or advance care planning conversation
Measured: 6 months
Secondary outcomes (6)
Number of Participants With CODE Status Limitations
Documented choices regarding CPR and mechanical ventilation in the EHR
Measured: 6 months
Rate of Palliative Care Consultation
Use of palliative care services (consults, outpatient visits) in the EHR
Measured: 6 months
Rate of Hospice Use
Use of hospice documented in the EHR
Measured: 6 months
Confidence in Future Care
(in person survey) patient confidence that they will receive the right care at the right time by their health system. The scale ranged from 1 Not at all confident to 5 Very confident. Higher values represent a better outcome.
Measured: 6 months
Communication and Decisional Satisfaction
(In person survey) patient satisfaction with communication and decision making.The scale range is from 1- Strongly Disagree to 5 - Strongly Disagree. Higher values represent better outcomes. Subscales were combined questions were summed to compute a total score. The lowest possible score is a 9 and the highest possible score is 45. Lower scores indicate lower communication and decisional satisfaction.
Measured: 6 months
Decisional Regret
(In person survey) patient regret regarding decision making. The response range is 1 - Strongly Disagree to 5 - Strongly agree. Higher numbers represent a worse outcome. Scale questions were summed to compute a total score. The lowest possible score is 2 and the highest possible score is 10. Lower scores indicate less decisional regret.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Aug 2018
- Study start15 Apr 2020
- Primary completion23 Nov 2022
- Study completion30 Sep 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Other CancerStudies of the same condition, open and under way.
- More trials run by Dana-Farber Cancer InstituteThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 13,800 participants (actual)
Sponsor and investigators
- Lead sponsor
- Dana-Farber Cancer Institute
- Sponsor type
- University, hospital or other
- Collaborators
- Massachusetts General Hospital, Boston Medical Center, Northwell Health, Mayo Clinic, Duke University, National Institute on Aging (NIA)
- Responsible party
- Principal investigator, James A. Tulsky, Dana-Farber Cancer Institute
- Investigators
- James A. Tulsky, MD, Principal investigator, Dana-Farber Cancer Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03609177
- Sponsor's protocol ID
- 18-276
- Other IDs
- UG3AG060626
- Acronym
- ACP-PEACE
- Status last verified
- Oct 2025
- First submitted
- 25 Jul 2018
- Last updated
- 21 Oct 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Volandes AE, Chang Y, Lakin JR, Paasche-Orlow MK, Lindvall C, Zupanc SN, Martins-Welch D, Carney MT, Burns EA, Itty J, Emmert-Tangredi K, Martin NJ, Sanghani S, Tilburt J, Pollak KI, Davis AD, Garde C, Barry MJ, El-Jawahri A, Quintiliani L, Sciacca K, Goldman J, Tulsky JA. An Intervention to Increase Advance Care Planning Among Older Adults With Advanced Cancer: A Randomized Clinical Trial. JAMA Netw Open. 2025 May 1;8(5):e259150. doi: 10.1001/jamanetworkopen.2025.9150.
PubMed 40343696Lakin JR, Gundersen DA, Lindvall C, Paasche-Orlow MK, Tulsky JA, Brannen EN, Pollak KI, Kennedy D, McLeggon JA, Stout JJ, Volandes A; ACP-PEACE Investigators. A Yet Unrealized Promise: Structured Advance Care Planning Elements in the Electronic Health Record. J Palliat Med. 2021 Aug;24(8):1221-1225. doi: 10.1089/jpm.2020.0774. Epub 2021 Apr 7.
PubMed 33826860Lakin JR, Brannen EN, Tulsky JA, Paasche-Orlow MK, Lindvall C, Chang Y, Gundersen DA, El-Jawahri A, Volandes A; ACP-PEACE Investigators. Advance Care Planning: Promoting Effective and Aligned Communication in the Elderly (ACP-PEACE): the study protocol for a pragmatic stepped-wedge trial of older patients with cancer. BMJ Open. 2020 Jul 14;10(7):e040999. doi: 10.1136/bmjopen-2020-040999.
PubMed 32665394
Study at a glance
From the registry record, last updated by the sponsor on 21 Oct 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Improving Advance Care Planning in Oncology: A Pragmatic, Cluster-Randomized Trial Integrating Patient Videos and Clinician Communication Training
- ClinicalTrials.gov ID
- NCT03609177
- Acronym / sponsor ID
- ACP-PEACE / 18-276
- Conditions
- Other Cancer
- Keywords
- Cancer Care
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 13,800 participants (actual)
- Lead sponsor
- Dana-Farber Cancer InstituteUniversity, hospital or other
- Collaborators
- Massachusetts General Hospital, Boston Medical Center, Northwell Health, Mayo Clinic, Duke University, National Institute on Aging (NIA)
- Study start
- 15 Apr 2020 (actual)
- Primary completion
- 23 Nov 2022 (actual)
- Study completion
- 30 Sep 2024 (actual)
- First posted
- 1 Aug 2018 (actual)
- Results
- Posted 11 Sep 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
In this research study, the investigators are working to help oncologists better serve patients by delivering more patient-centered, goal-concordant care that may improve health care delivery.
- It is expected that about 30,000 people will take part in this research study, 29,550 of these patients, the vast majority, will be included only for medical record review.
Detailed description
The purpose of this study is to improve the quality of care provided to millions of older Americans with cancer. The investigators are working to help oncologists better serve patients by delivering more patient-centered, goal-concordant care that may dramatically improve health care delivery.
This is pragmatic stepped wedge cluster randomized trial (SW-CRT) of a Comprehensive ACP (Advance Care Planning) Program among older oncology patients. The ACP Program will include training clinicians in communication skills and using video decision aids for participants.
- This study will involve medical record review of 30,000 people age 65 or older with advanced cancer.
We will also recruit 450 eligible patients (150 patients from each of our three sites broken down into 75 patients during the control phase and 75 patients during the intervention phase) to conduct a survey for our secondary patient-centered outcomes (confidence, satisfaction with physician communication, patient decisional satisfaction and regret). From among this sub-group we will engage 240 participants (80 from each of our three sites broken down into 40 patients during the control phase and 40 patients during the intervention phase) in an activity to film video declarations of their preferences.
During the first year, three pilot sites (one at each health care system) will trial the intervention. The subjects recruited at these pilot sites will not be included in the final analysis. Thus, the main trial will begin during year 2 and continue through year 5 with recruitment of 30,000 subjects for the primary outcome at 30 oncology clinics. The first year pilot will serve to inform the larger roll-out and the intervention may change during the first year based on pilot-clinic experience.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Advance Care Planning | Experimental | Other: Clinician Communication Skills Training, Other: Advance Care Planning (ACP) Decisions Videos Decisions Aids-Survey: * A group of older patients with advanced cancer (N=450) will have a survey over the course of the 36 months of recruitment. * Participants will be provided written copies of the questions to follow along during the interviews |
| Advance Care Planning-Video Declaration | Experimental | Other: Clinician Communication Skills Training, Other: Advance Care Planning (ACP) Decisions Videos Decisions Aids, Other: Video Declarations (ViDec)Video Declaration: * From among this group of 450 participants, the video declaration of preferences activity will be conducted with 240 patients. * For those participants that agree to the video declaration, they will proceed with recording of their video declarations * The RA will begin by reading a standardized introduction to aid the subject do the video |
| Comprehensive Record Review of ACP | Other | Other: Clinician Communication Skills Training, Other: Advance Care Planning (ACP) Decisions Videos Decisions Aids, Other: Video Declarations (ViDec)* A review of Medical orders for resuscitation preferences in the electronic health record * A review of Medical orders for Palliative care consultations preferences in the electronic health record * A review of Medical orders for Hospice use preferences in the electronic health record |
| Main Study Arm | Experimental | Other: Clinician Communication Skills Training, Other: Advance Care Planning (ACP) Decisions Videos Decisions Aids, Other: Video Declarations (ViDec)Patients with cancer being seen at the 30 oncology clinics will be exposed to clinicians who have had communication skills training (Vital Talk) and who are using video decision aids (ACP Decisions). Our main outcome is advance care planning documentation. |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (6 listed)
- More than one oncologist
- Serve a patient population that is at least 30% aged 65 or older
- Disease-based oncology clinic
- Any patient affiliated with one of the study clinics who speaks English and is aged 65 or older with advanced cancer is eligible for participation. Advanced cancer is defined as metastatic disease for solid tumors and recurrent or refractory disease for hematological malignancies. There are no exclusions based on gender, race, or ethnicity.
Key exclusion criteria (4 listed)
- Adults unable to consent
- Individuals who are not yet adults (infants, children, teenagers)
- Pregnant women
- Prisoners
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Clinician Communication Skills TrainingAlso: Vital Talk Communication Skills TrainingCommunication skills training | Other | Advance Care Planning, Advance Care Planning-Video Declaration, Comprehensive Record Review of ACP, Main Study Arm |
| Advance Care Planning (ACP) Decisions Videos Decisions AidsACP Decisions video decision aids | Other | Advance Care Planning, Advance Care Planning-Video Declaration, Comprehensive Record Review of ACP, Main Study Arm |
| Video Declarations (ViDec)Recording of patient advance care planning videos | Other | Advance Care Planning-Video Declaration, Comprehensive Record Review of ACP, Main Study Arm |
Primary outcome
Number of Participants With Advance Care Planning Documentation
Time frame: 6 months
Any advance directive (e.g., living will, POLST, etc.) and changes of resuscitation orders or any indication in the EHR of a goals-of-care or advance care planning conversation
6 secondary outcomes
Number of Participants With CODE Status Limitations
Time frame: 6 months
Rate of Palliative Care Consultation
Time frame: 6 months
Rate of Hospice Use
Time frame: 6 months
Confidence in Future Care
Time frame: 6 months
Communication and Decisional Satisfaction
Time frame: 6 months
Decisional Regret
Time frame: 6 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Oct 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 40343696Volandes AE, Chang Y, Lakin JR, Paasche-Orlow MK, Lindvall C, Zupanc SN, Martins-Welch D, Carney MT, Burns EA, Itty J, Emmert-Tangredi K, Martin NJ, Sanghani S, Tilburt J, Pollak KI, Davis AD, Garde C, Barry MJ, El-Jawahri A, Quintiliani L, Sciacca K, Goldman J, Tulsky JA. An Intervention to Increase Advance Care Planning Among Older Adults With Advanced Cancer: A Randomized Clinical Trial. JAMA Netw Open. 2025 May 1;8(5):e259150. doi: 10.1001/jamanetworkopen.2025.9150.
- Derived from this study: PubMed 33826860Lakin JR, Gundersen DA, Lindvall C, Paasche-Orlow MK, Tulsky JA, Brannen EN, Pollak KI, Kennedy D, McLeggon JA, Stout JJ, Volandes A; ACP-PEACE Investigators. A Yet Unrealized Promise: Structured Advance Care Planning Elements in the Electronic Health Record. J Palliat Med. 2021 Aug;24(8):1221-1225. doi: 10.1089/jpm.2020.0774. Epub 2021 Apr 7.
- Derived from this study: PubMed 32665394Lakin JR, Brannen EN, Tulsky JA, Paasche-Orlow MK, Lindvall C, Chang Y, Gundersen DA, El-Jawahri A, Volandes A; ACP-PEACE Investigators. Advance Care Planning: Promoting Effective and Aligned Communication in the Elderly (ACP-PEACE): the study protocol for a pragmatic stepped-wedge trial of older patients with cancer. BMJ Open. 2020 Jul 14;10(7):e040999. doi: 10.1136/bmjopen-2020-040999.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
James A. Tulsky, MD principal investigator
Dana-Farber Cancer Institute
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Clinician Communication Skills Training, Advance Care Planning (ACP) Decisions Videos Decisions Aids and Video Declarations (ViDec) in people with Other Cancer, run by Dana-Farber Cancer Institute at 4 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Oct 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 11 Sep 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants With Advance Care Planning Documentation (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03609177, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Oct 2025.