NCT06786104

Brief Summary

The goal of this clinical trial is to learn if the VIDEO-PEDS intervention works to improve Goals of Care communication between clinicians and parents of children with cancer. The main questions it aims to answer are: Does the intervention improve Goals of Care documentation? Does it improve patient outcomes (including less invasive preferences for resuscitation and interventions, less hospital utilization, and more palliative care and hospice use)? Does it improve parent outcomes (including health satisfaction and feeling heard and understood per survey scores)?

Trial Health

77
On Track

Trial Health Score

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

Enrollment
567

participants targeted

Target at P75+ for not_applicable

Timeline
47mo left

Started May 2026

Longer than P75 for not_applicable

Geographic Reach
1 country

4 active sites

Status
recruiting

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

Study Progress1%
May 2026Apr 2030

First Submitted

Initial submission to the registry

January 7, 2025

Completed
15 days until next milestone

First Posted

Study publicly available on registry

January 22, 2025

Completed
1.3 years until next milestone

Study Start

First participant enrolled

May 5, 2026

Completed
3.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 15, 2030

Expected
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 15, 2030

Last Updated

May 14, 2026

Status Verified

May 1, 2026

Enrollment Period

3.7 years

First QC Date

January 7, 2025

Last Update Submit

May 11, 2026

Conditions

Pediatric Cancer

Keywords

Advanced Care PlanningPalliative CareEnd of Life

Outcome Measures

Primary Outcomes (4)

  • Goals-of-Care Discussion

    Percentage of parents who held conversations with their medical team about goals, values, or priorities for treatment and outcomes as per documentation in the medical record.

    At the end of Cycles 1, 2, and 3 (each cycle is 9 months)

  • Code Status Limitation

    Percentage of parents who communicate limitations to cardiopulmonary resuscitation and intubation with their medical team as per documentation in the medical record.

    At the end of Cycles 1, 2, and 3 (each cycle is 9 months)

  • Palliative Care

    Percentage of parents who mention a visit with a specialty palliative care clinician, mention of specialist palliative care discussion, or patient preferences regarding seeing a palliative care clinician to their medical team as per documentation in the medical record.

    At the end of Cycles 1, 2, and 3 (each cycle is 9 months)

  • Time-Limited Trial

    Percentage of parents who engage in conversations with their medical team about the use of a treatment or procedure for a set amount of time with a pre-defined goal and plan related to the outcome at the end of the trial as per documentation in the medical record.

    At the end of Cycles 1, 2, and 3 (each cycle is 9 months)

Secondary Outcomes (3)

  • Acceptability themes from qualitative data

    2 years

  • Feasibility by % of parents

    2 years

  • Parent Satisfaction scores

    2 years

Study Arms (4)

UH3 RWCT Arm - Intervention

EXPERIMENTAL

This group will receive the VIDEO-PEDS intervention.

Other: VIDEO-PEDS

UH3 RWCT Arm - Control

NO INTERVENTION

This group will receive usual care until the 9-month wait period expires.

UG3 Pilot Intervention

OTHER

This group will receive the 3-month pilot version of the VIDEO-PEDS intervention.

Other: VIDEO-PEDS pilot

UG3 Focus Group

OTHER

This group will participate in the virtual parent focus groups.

Other: Focus Group

Interventions

VIDEO-PEDSOTHER

Following enrollment, parents will receive a link to view the refined video decision aid that is designed to prompt parents to think about their goals of care for their child with cancer, and then to react by engaging in communication with a trained member of the research team called the Navigator and eventually their clinical team over the course of the 9-month study duration.

UH3 RWCT Arm - Intervention
VIDEO-PEDS pilotOTHER

This is the 3-month pilot version of the intervention, which will be further developed for the eventual RWCT.

UG3 Pilot Intervention
Focus GroupOTHER

Parents will view the Video aid and provide fascilitated feedback in an audio-recorded virtual group setting.

UG3 Focus Group

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Patient
  • Age 0-12 years
  • Diagnosed with any type or stage of cancer
  • Receiving cancer directed treatment
  • Parent
  • Decision maker for the child.
  • Biological parent, step-parent, legal guardian (e.g., adoptive parent), or grandparent with medical consent authority.
  • Able to communicate in English or Spanish (the languages of the video decision aids).

You may not qualify if:

  • Patient
  • Not receiving primary medical care from the cancer clinic (e.g., second-opinion consultations only)
  • Already referred to and fully consulted by the palliative care team
  • Prognosis of less than a 2-month life expectancy
  • Parent
  • Psychological state not appropriate for GOC discussions, as determined by the primary oncologist per the opt-out.
  • Participants who do not speak English or Spanish

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

Children's of Alabama at Birmingham

Birmingham, Alabama, 35233, United States

RECRUITING

Children's Hospital of Atlanta

Atlanta, Georgia, 30342, United States

RECRUITING

Dana Farber Cancer Institute

Boston, Massachusetts, 02215, United States

RECRUITING

Dartmouth Hitchcock Medical Center

Lebanon, New Hampshire, 03756, United States

ACTIVE NOT RECRUITING

Related Publications (6)

  • Volandes AE, Zupanc SN, Lakin JR, Cabral HJ, Burns EA, Carney MT, Lopez S, Itty J, Emmert K, Martin NJ, Cole T, Dobie A, Cucinotta T, Joel M, Caruso LB, Henault L, Dugas JN, Astone K, Winter M, Wang N, Davis AD, Garde C, Rodriguez PM, El-Jawahri A, Moseley ET, Das S, Sciacca K, Ramirez AM, Gromova V, Lambert S, Sanghani S, Lindvall C, Paasche-Orlow MK. Video Intervention and Goals-of-Care Documentation in Hospitalized Older Adults: The VIDEO-PCE Randomized Clinical Trial. JAMA Netw Open. 2023 Sep 5;6(9):e2332556. doi: 10.1001/jamanetworkopen.2023.32556.

    PMID: 37695586BACKGROUND

  • 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: 37433434BACKGROUND

  • Feifer D, Helton G, Wolfe J, Volandes A, Snaman JM. Adolescents and young adults with cancer conversations following participation in an advance care planning video pilot. Support Care Cancer. 2024 Feb 17;32(3):164. doi: 10.1007/s00520-024-08372-y.

    PMID: 38367086BACKGROUND

  • Lindsay ME, de Oliveira S, Sciacca K, Lindvall C, Ananth PJ. Harnessing Natural Language Processing to Assess Quality of End-of-Life Care for Children With Cancer. JCO Clin Cancer Inform. 2024 Sep;8:e2400134. doi: 10.1200/CCI.24.00134.

    PMID: 39265122BACKGROUND

  • Johnston EE, Alvarez E, Saynina O, Sanders L, Bhatia S, Chamberlain LJ. Disparities in the Intensity of End-of-Life Care for Children With Cancer. Pediatrics. 2017 Oct;140(4):e20170671. doi: 10.1542/peds.2017-0671.

    PMID: 28963112BACKGROUND

  • Lindvall C, Deng CY, Moseley E, Agaronnik N, El-Jawahri A, Paasche-Orlow MK, Lakin JR, Volandes A, Tulsky TAIJA. Natural Language Processing to Identify Advance Care Planning Documentation in a Multisite Pragmatic Clinical Trial. J Pain Symptom Manage. 2022 Jan;63(1):e29-e36. doi: 10.1016/j.jpainsymman.2021.06.025. Epub 2021 Jul 14.

    PMID: 34271146BACKGROUND

MeSH Terms

Conditions

NeoplasmsDeath

Interventions

Focus Groups

Condition Hierarchy (Ancestors)

Pathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Data CollectionEpidemiologic MethodsInvestigative TechniquesHealth Care Evaluation MechanismsQuality of Health CareHealth Care Quality, Access, and EvaluationPublic HealthEnvironment and Public Health

Study Officials

  • Angelo Volandes, MD

    Dartmouth-Hitchcock Medical Center

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Joanne E Wolfe, MD

CONTACT

6177242911jwolfe@mgh.harvard.edu

Madeline Avery, MPH

CONTACT

9785053217meavery@mgh.harvard.edu

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Model Details: The initial development and pilot phase is not randomized and the latter RWCT phase is 1:1 parallel randomized arms.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Chief of Pediatrics

Study Record Dates

First Submitted

January 7, 2025

First Posted

January 22, 2025

Study Start

May 5, 2026

Primary Completion (Estimated)

January 15, 2030

Study Completion (Estimated)

April 15, 2030

Last Updated

May 14, 2026

Record last verified: 2026-05

Data Sharing

IPD Sharing
Will not share

Locations

US(4)