Video Inspired Discussions About Ethical Outcomes in Pediatrics
ConditionPediatric Cancer
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
AgeNot listed
SponsorMassachusetts General Hospital
About this trial
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)?
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Age 0-12 years
Diagnosed with any type or stage of cancer
Receiving cancer directed treatment
Decision maker for the child.
Disqualifiers
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
Visually impaired beyond 20/200 corrected and unable to view the video (note: hearing impaired is not an exclusion as the videos are closed captioned).
Trial design
Design model
Parallel
Treatments tested in this trial
VIDEO-PEDS
Other interventionFollowing 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.
VIDEO-PEDS pilot
Other interventionThis is the 3-month pilot version of the intervention, which will be further developed for the eventual RWCT.
Focus Group
Other interventionParents will view the Video aid and provide fascilitated feedback in an audio-recorded virtual group setting.
Treatment groups
567 Participants
are divided into 4 treatment groupsGroup A: UH3 RWCT Arm - InterventionExperimental treatment 1 intervention
Group B: UH3 RWCT Arm - ControlNo intervention 0 interventions
Group C: UG3 Pilot InterventionOther 1 intervention
Group D: UG3 Focus GroupOther 1 intervention
Trial outcomes
Primary outcomes
1
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.
Time frame
At the end of Cycles 1, 2, and 3 (each cycle is 9 months)2
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.
Time frame
At the end of Cycles 1, 2, and 3 (each cycle is 9 months)3
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.
Time frame
At the end of Cycles 1, 2, and 3 (each cycle is 9 months)4
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.
Time frame
At the end of Cycles 1, 2, and 3 (each cycle is 9 months)Secondary outcomes
1
Acceptability themes from qualitative data
For the development phase, qualitative group interviews will yield information about participant preferences. For the pilot phase, qualitative individual interviews will yield information about participant preferences after a 3-month study duration.
Time frame
2 years2
Feasibility by % of parents
Feasibility will be assessed as ability to identify, recruit, and retain participants as a percentage. 70% of those screened should be eligible for approach after the Validation and Opt-out Steps. 70% approached should agree to participate. 70% should complete the study. (\<30% should be lost to follow-up or withdraw from the study.)
Time frame
2 years3
Parent Satisfaction scores
A parent survey will measure how parents felt heard and understood by the medical team and how satisfied they were with the care received using five validated items from the measure Feeling Heard and Understood and two items from the Survey about Caring for Children with Cancer (SCCC) all answered on a 5-point Likert Scale. Scores range from 0 to 100 with 0 being the lowest satisfaction.
Time frame
2 yearsSponsors and contacts
Click on the lead sponsor to view all of their trials.
Massachusetts General Hospital
Lead sponsor
National Cancer Institute (NCI)
Collaborator
Dartmouth-Hitchcock Medical Center
Collaborator
Dana-Farber Cancer Institute
Collaborator
Yale University
Collaborator
Emory University
Collaborator
Children's Healthcare of Atlanta
Collaborator
University of Alabama at Birmingham
Collaborator
Source ClinicalTrials.gov