An interventional study of VIDEO-PEDS and VIDEO-PEDS pilot in Pediatric Cancer, sponsored by Massachusetts General Hospital. Recruiting at 4 sites in United States. Per ClinicalTrials.gov, last updated 2026-05-14.
Sponsored by Massachusetts General Hospital · Not applicable, Interventional, and Supportive care
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)?
Background
Parents of children with advanced cancer often face challenging decisions about goals of care (GOC) amidst high stress and limited understanding of medical interventions. Despite evidence that early and informed GOC discussions improve end-of-life experiences and align care with family values, such conversations remain infrequent in pediatric oncology. Barriers such as communication gaps, literacy challenges, and cultural differences exacerbate disparities, particularly among African American, Hispanic, and rural populations. The Video Images about Decisions for Ethical Outcomes in Pediatrics (VIDEO-PEDS) trial aims to address these gaps through an innovative video-based intervention. Similar interventions were effective in an adult cancer population.
Aims
Design
This study will be conducted in two phases:
Pilot Study
Randomized Waitlist-Controlled Trial (RWCT)
Setting
The study will take place across three diverse healthcare systems:
Participants/Subjects
Pilot Study:
Parents of 27 children (9 per site) aged 0-12 years with cancer will be recruited to test the intervention.
RWCT:
Interventions
Pilot Study:
RWCT:
Methods Patients will be screened from oncology patient lists at the three enrolling sites. A research assistant will complete an eligibility checklist for all meeting general criteria after an initial screening. For those potentially eligible, an eligibility checklist will be reviewed by a site PI and validated (eventually through REDCap). Once deemed eligible, an opt-out email is sent to the primary clinician for permission to approach. Invitations will then be sent by mail or email, followed by an in-person or phone approach. Prospective verbal informed consent will be obtained from the parents who choose to participate. Participation then involves viewing the Video. Video cards (inexpensive disposable devices) may be provided to reduce barriers to participation. Following the viewing, an extensively trained Navigator from the research team will discuss the goals of care broadly with the parent throughout the study duration, prompting engagement with the primary oncologist.
Development Phase:
Pilot Study:
o An abbreviated 3-month version of the intervention will be tested, including pre- and post-study surveys.
RWCT:
The investigators will conduct a large, pragmatic, randomized, waitlist-controlled trial (RWCT). The investigators will conduct three cycles of nine months. Thus, over the course of 27 months, three cycles of unique patients will be randomized (9 months per cycle x 3 cycles = 27 months). The recruitment period is 36 months to account for the last nine months of intervention for Waitlist-Controls in the last cycle. At the start of each of the three cycles, the investigators will ask each health system to curate and finalize a list of all eligible patients. For each cycle, one-third of the total 504 (i.e., N=168) will be randomized in 1:1 assignment, stratified by health system and demographic characteristics (African American, Hispanic, and rural) to Waitlist-Control or GOC Video Intervention.
A subgroup of 136 parents (total) will be asked to complete a survey via REDCap. These parents will be evenly divided between the two arms of the study and the three study sites. Participants will receive a self-administered survey via email/mailing at the beginning of a nine-month period and again at the end.
A subgroup of 12 parents (total) will be asked to complete an audio-recorded exit interview. The investigators will ask parents to comment on the perceived usefulness of the intervention, whether anything was learned, and how communication may have changed with the participant's clinicians since the intervention.
A subgroup of 25 parents (total) will have the Navigator conversation audio-recorded for intervention fidelity. A subset of these will be transcribed and further analyzed.
Stakeholder Interviews will be conducted with 18 clinicians (6 per site) including key clinical leaders of services.
Data Analysis:
Outcomes
While more detail on Outcomes exists in that section, the primary outcome for the RWCT is the presence of GOC documentation in the EHR. Secondary outcomes include:
Exploratory analyses will examine subgroup effects among African American, Hispanic, and rural participants, as well as the cost-effectiveness and scalability of the intervention.
10,818 studies on the registry are indexed under Neoplasms; 2,324 are open to participants now.
This study's planned enrollment of 567 is above the median of 60 across 7,703 interventional studies indexed under Neoplasms.
Browse Neoplasms studies →Massachusetts General Hospital is the lead sponsor of 2,586 studies on the registry; 447 are open to participants now.
Of its 222 completed or terminated interventional studies of FDA-regulated products, 168 (76%) have results posted.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Patient
Parent
Exclusion Criteria:
Patient
Parent
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
Life expectancy
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
This group will receive the VIDEO-PEDS intervention.
Other: VIDEO-PEDS
This group will receive usual care until the 9-month wait period expires.
This group will receive the 3-month pilot version of the VIDEO-PEDS intervention.
Other: VIDEO-PEDS pilot
This group will participate in the virtual parent focus groups.
Other: Focus Group
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.
This is the 3-month pilot version of the intervention, which will be further developed for the eventual RWCT.
Parents will view the Video aid and provide fascilitated feedback in an audio-recorded virtual group setting.
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)
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)
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)
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)
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 years
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 years
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 years
Not enrolling at this site.
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: No
Started May 2026 (actual). Primary completion is estimated for Jan 2030, 44 months after the start.
Of 1,981 non-industry interventional studies with no phase under Neoplasms, half reached primary completion within 29 months of starting (the median), counting those still running; a quarter within 13 and three quarters within 52. This study's planned 44 months is above that.
Counting every sponsor, half of 2,056 studies reached it within 29 months; a quarter within 13 and three quarters within 52.
Neoplasms covers many different conditions, not one, so the studies compared here vary widely. Read these figures as a rough guide.
How these figures are worked out, and which studies are left out of them.
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