Videos for Advance Care Planning in Young Adults

NCT ID: NCT04149704

Last Updated: 2025-01-20

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 102 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-12-13
• Study Completion Date: 2022-05-05

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.

Conditions

Advanced Cancer

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: HEALTH_SERVICES_RESEARCH
• Blinding Strategy: NONE

Study Groups

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

Group Type: EXPERIMENTAL

ACP video decision aid

Intervention Type: BEHAVIORAL

10 minute video decision aid describing the goals-of-care options

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

Group Type: ACTIVE_COMPARATOR

Usual Care-

Intervention Type: OTHER

Verbal description of the three types of care

Interventions

ACP video decision aid

10 minute video decision aid describing the goals-of-care options

Intervention Type: BEHAVIORAL

Usual Care-

Verbal description of the three types of care

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

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

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Dana-Farber Cancer Institute

OTHER

Sponsor Role: lead

Responsible Party

Jennifer Snaman, MD, MS

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Jennifer Snaman, MD, MS

Role: PRINCIPAL_INVESTIGATOR

Dana-Farber Cancer Institute

Locations

Boston Children's Hospital

Boston, Massachusetts, United States

Brigham and Women's Hospital

Boston, Massachusetts, United States

Dana Farber Cancer Institute

Boston, Massachusetts, United States

Countries

United States

References

Snaman JM, Feifer D, Helton G, Chang Y, El-Jawahri A, Volandes AE, Wolfe J. A Pilot Randomized Trial of an Advance Care Planning Video Decision Support Tool for Adolescents and Young Adults With Advanced Cancer. J Natl Compr Canc Netw. 2023 Jul;21(7):715-723.e17. doi: 10.6004/jnccn.2023.7021.

Reference Type: DERIVED

PMID: 37433434 (View on PubMed)

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Document Type: Informed Consent Form

View Document

Other Identifiers

19-409

Identifier Type: -

Identifier Source: org_study_id