Videos for Advance Care Planning in Young Adults
1 other identifier
interventional
102
1 country
3
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Dec 2019
Typical duration for not_applicable
3 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 31, 2019
CompletedFirst Posted
Study publicly available on registry
November 4, 2019
CompletedStudy Start
First participant enrolled
December 13, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 5, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
May 5, 2022
CompletedResults Posted
Study results publicly available
January 20, 2025
CompletedJanuary 20, 2025
December 1, 2024
2.4 years
October 31, 2019
October 16, 2022
December 6, 2024
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 Outcomes (1)
Increased Advance Care Planning (ACP) Conversations
Baseline and 3 months
Study Arms (2)
ACP video decision aid
EXPERIMENTALThe 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
ACTIVE COMPARATORThe 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
Interventions
10 minute video decision aid describing the goals-of-care options
Eligibility Criteria
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (3)
Boston Children's Hospital
Boston, Massachusetts, 02115, United States
Brigham and Women's Hospital
Boston, Massachusetts, 02115, United States
Dana Farber Cancer Institute
Boston, Massachusetts, 02115, United States
Related Publications (1)
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.
PMID: 37433434DERIVED
Results Point of Contact
- Title
- Jennifer Snaman
- Organization
- Dana-Farber Cancer Institute
Study Officials
- PRINCIPAL INVESTIGATOR
Jennifer Snaman, MD, MS
Dana-Farber Cancer Institute
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- HEALTH SERVICES RESEARCH
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
October 31, 2019
First Posted
November 4, 2019
Study Start
December 13, 2019
Primary Completion
May 5, 2022
Study Completion
May 5, 2022
Last Updated
January 20, 2025
Results First Posted
January 20, 2025
Record last verified: 2024-12
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, ICF
- Time Frame
- Data can be shared no earlier than 1 year following the date of publication
- Access Criteria
- DFCI - Contact the Belfer Office for Dana-Farber Innovations (BODFI) at innovation@dfci.harvard.edu
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.