Videos for Advance Care Planning in Young Adults

Sponsor

Dana-Farber Cancer Institute (Other)

Overall Status

Completed

CT.gov ID

NCT04149704

Collaborator

(none)

100

Enrollment

Locations

Arms

28.7

Actual Duration (Months)

33.3

Patients Per Site

1.2

Patients Per Site Per Month

Study Details

Study Description

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

Condition or Disease	Intervention/Treatment	Phase
Advanced Cancer	Behavioral: ACP video decision aid Other: Usual Care-	N/A

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 Design

Study Type:

Interventional

Actual Enrollment :

100 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Health Services Research

Official Title:

Videos for Advance Care Planning in Young Adults

Actual Study Start Date :

Dec 13, 2019

Actual Primary Completion Date :

May 5, 2022

Actual Study Completion Date :

May 5, 2022

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

Increased Concordance Rate [baseline, 3 months]
AYA with advanced cancer and caregivers randomized to the video will have higher concordance between patients and caregivers

Secondary Outcome Measures

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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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:

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.
Treated at Dana-Farber Cancer Institute or Massachusetts General Hospital

Exclusion criteria will include:

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.
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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Boston Children's Hospital	Boston	Massachusetts	United States	02115
2	Brigham and Women's Hospital	Boston	Massachusetts	United States	02115
3	Dana Farber Cancer Institute	Boston	Massachusetts	United States	02115

Sponsors and Collaborators

Dana-Farber Cancer Institute

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Jennifer Snaman, MD, MS, Principal Investigator, Dana-Farber Cancer Institute

ClinicalTrials.gov Identifier:

NCT04149704

Other Study ID Numbers:

19-409

First Posted:

Nov 4, 2019

Last Update Posted:

Jun 1, 2022

Last Verified:

May 1, 2022

Individual Participant Data (IPD) Sharing Statement:

Yes

Plan to Share IPD:

Yes

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Jennifer Snaman, MD, MS, Principal Investigator, Dana-Farber Cancer Institute

Advanced Cancer

Study Results

No Results Posted as of Jun 1, 2022