NCT04149704

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

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
102

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Dec 2019

Typical duration for not_applicable

Geographic Reach
1 country

3 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 31, 2019

Completed
4 days until next milestone

First Posted

Study publicly available on registry

November 4, 2019

Completed
1 month until next milestone

Study Start

First participant enrolled

December 13, 2019

Completed
2.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 5, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 5, 2022

Completed
2.7 years until next milestone

Results Posted

Study results publicly available

January 20, 2025

Completed
Last Updated

January 20, 2025

Status Verified

December 1, 2024

Enrollment Period

2.4 years

First QC Date

October 31, 2019

Results QC Date

October 16, 2022

Last Update Submit

December 6, 2024

Conditions

Keywords

Advanced Cancer

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

EXPERIMENTAL

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

Standard Care

ACTIVE COMPARATOR

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-

Interventions

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

ACP video decision aid

Verbal description of the three types of care

Standard Care

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

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

Location

Brigham and Women's Hospital

Boston, Massachusetts, 02115, United States

Location

Dana Farber Cancer Institute

Boston, Massachusetts, 02115, United States

Location

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.

Results Point of Contact

Title
Jennifer Snaman
Organization
Dana-Farber Cancer Institute

Study Officials

  • Jennifer Snaman, MD, MS

    Dana-Farber Cancer Institute

    PRINCIPAL INVESTIGATOR

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

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.

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

Locations