NCT03609177

Advance Care Planning: Promoting Effective and Aligned Communication in the Elderly

Improving Advance Care Planning in Oncology: A Pragmatic, Cluster-Randomized Trial Integrating Patient Videos and Clinician Communication Training

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 13,800 (actual)
• Sponsor: Dana-Farber Cancer Institute · Academic / Other
• Sex: All
• Age: 65 Years
• Healthy volunteers: Not accepted

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. \- 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.

Conditions

• Other Cancer

Interventions

Type	Name	Description
OTHER	Clinician Communication Skills Training	Communication skills training
OTHER	Advance Care Planning (ACP) Decisions Videos Decisions Aids	ACP Decisions video decision aids
OTHER	Video Declarations (ViDec)	Recording of patient advance care planning videos

Timeline

• Start date: 2020-04-15
• Primary completion: 2022-11-23
• Completion: 2024-09-30
• First posted: 2018-08-01
• Last updated: 2025-10-21
• Results posted: 2025-09-11

Locations

4 sites across 1 country: United States