Videos for Advance Care Planning in Young Adults

Not Applicable

Completed

• Conditions: Advanced Cancer
• Interventions: Behavioral: ACP video decision aid; Other: Usual Care-

• Registration Number: NCT04149704
• Lead Sponsor: Dana-Farber Cancer Institute

Brief Summary

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

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 Timeline

• Study First Submitted: 2019-10-31
• Study First Submitted QC: 2019-10-31
• Study First Posted: 2019-11-04
• Study Start: 2019-12-13
• Primary Completion: 2022-05-05
• Study Completion: 2022-05-05
• Results First Submitted: 2022-10-16
• Status Verified: 2024-12
• Results First Submitted QC: 2024-12-06
• Last Update Submitted: 2024-12-06
• Results First Posted: 2025-01-20
• Last Update Posted: 2025-01-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 102

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
ACP video decision aid	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
Standard Care	Usual 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

Primary Outcome Measures

Name	Time	Method
Increased Concordance Rate in Stated Goals of Care (Life-prolonging Medical Care, Selective Medical Care, or Comfort-focused Care)	baseline, 3 months	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

Secondary Outcome Measures

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

Trial Locations

Locations (3)

Boston Children's Hospital; 🇺🇸 Boston, Massachusetts, United States

Dana Farber Cancer Institute; 🇺🇸 Boston, Massachusetts, United States

Brigham and Women's Hospital; 🇺🇸 Boston, Massachusetts, United States