Videos for Advance Care Planning in Young Adults

This study is a randomized trial of adolescent and young adults with advanced cancer and their caregivers to assess preferences for care in advanced cancer. This research study is examining the similarities and differences between patient's and caregiver's goals of cancer care.

The names of the study interventions involved in this study may include:

• Questionnaires
• Video
• Phone Interview

Study Overview

• Status: Completed
• Conditions: Advanced Cancer
• Intervention / Treatment: Behavioral: ACP video decision aid; Other: Usual Care-

Detailed Description

The research study procedures include: screening for eligibility and study interventions including questionnaires and follow up visits.

- Patients and their caregivers will be randomized into the same group; either ACP video decision aid intervention or usual care.

• Patients' and caregivers' knowledge, preferences (goals of care, CPR, ventilation), and decisional conflict be assessed before and after the ACP video decision aid intervention or usual care.
• Participants will be in this research study for up to 3 months with only 2 study visits.
• It is expected that about 100 people (50 patients and 50 caregivers) will take part in this research study.

• Study Type: Interventional
• Enrollment (Actual): 102
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Massachusetts
    • Boston, Massachusetts, United States, 02115
      • Brigham and Women's Hospital
    • Boston, Massachusetts, United States, 02115
      • Dana Farber Cancer Institute
    • Boston, Massachusetts, United States, 02115
      • Boston Children's Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

All patients will be recruited from the outpatient clinics of Dana-Farber Cancer Institute (both pediatric and adult clinics),the inpatient settings of Boston Children's Hospital and Brigham and Women's Hospital, the inpatient or outpatient clinics of Massachusetts General Hospital, or virtually. Eligible study participants will give written consent to the primary investigator or study staff member before initiation of study procedures if recruited in-person. If participants are enrolled and complete study procedures virtually, they will provide verbal consent before initiating study procedures.

If in-person visits cannot be conducted, eligible participants will be still be mailed a pre-notice letter that offers the chance for participants to opt-out or opt-in via email or phone call. After one week, we will call participants we have not heard from and ask if they would consider participating.

Patient Eligibility criteria will include patients who are:

i) Diagnosed with advanced cancer (i.e., initial first-line therapy is unsuccessful, marked by progression or relapsed disease) ii) Aged between 18-39, which is the legal age for completing an ACP document (e.g., POLST/MOLST); iii) Speak English; and iv) Have a caregiver or identified surrogate decision maker who is able to participate.

v) Treated at Dana-Farber Cancer Institute or Massachusetts General Hospital

Exclusion criteria will include:

i) A diagnosis of low-grade glioma given the fact that progressive or relapsed low grade may not be clinically characterized as advanced disease and associated poor prognosis.

ii) Visually impaired (note, hearing impaired is not an exclusion as the video is closed captioned); iii) Psychological state not appropriate for ACP discussions as determined by the primary oncologist; and, iv) Unable to participate in ACP discussions due to mental incapacity as determined by the Short Portable Mental Status Questionnaire

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: ACP video decision aid; The research study procedures include: screening for eligibility and study interventions including questionnaires and follow up visits.; In-person interview where the patient and caregiver together will randomized to either the video aid intervention or standard care; 10 minute video decision aid: describing the goals-of-care options .; Follow telephone interview at 3 months	Behavioral: ACP video decision aid; 10 minute video decision aid describing the goals-of-care options
Active Comparator: Standard Care; The research study procedures include: screening for eligibility and study interventions including questionnaires and follow up visits.; In-person interview where the patient and caregiver together will randomized to either the video aid intervention or standard care; Receive the verbal description of the three types of care; Follow telephone interview at 3 months	Other: Usual Care-; Verbal description of the three types of care

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Increased Concordance Rate in Stated Goals of Care (Life-prolonging Medical Care, Selective Medical Care, or Comfort-focused Care)	AYA with advanced cancer and caregivers randomized to the video will have higher concordance in their stated goals of care between patients and caregivers at 3 month compared to baseline	baseline, 3 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Increased Advance Care Planning (ACP) Conversations	Patients randomized to the video will have more ACP conversations and documentation after 3 months.	Baseline and 3 months

Collaborators and Investigators

• Sponsor: Dana-Farber Cancer Institute
• Investigators: Principal Investigator: Jennifer Snaman, MD, MS, Dana-Farber Cancer Institute

Study record dates

Study Major Dates

• Study Start (Actual): December 13, 2019
• Primary Completion (Actual): May 5, 2022
• Study Completion (Actual): May 5, 2022

Study Registration Dates

• First Submitted: October 31, 2019
• First Submitted That Met QC Criteria: October 31, 2019
• First Posted (Actual): November 4, 2019

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: December 6, 2024
• Last Verified: December 1, 2024

More Information

Terms related to this study

• Keywords: Advanced Cancer
• Other Study ID Numbers: 19-409

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: The Dana-Farber / Harvard Cancer Center encourages and supports the responsible and ethical sharing of data from clinical trials. De-identified participant data from the final research dataset used in the published manuscript may only be shared under the terms of a Data Use Agreement. Requests may be directed to Sponsor Investigator or designee. The protocol and statistical analysis plan will be made available on Clinicaltrials.gov only as required by federal regulation or as a condition of awards and agreements supporting the research.
• IPD Sharing Time Frame: Data can be shared no earlier than 1 year following the date of publication
• IPD Sharing Access Criteria: DFCI - Contact the Belfer Office for Dana-Farber Innovations (BODFI) at innovation@dfci.harvard.edu
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No