Clinical trial NCT06786104: Video Inspired Discussions About Ethical Outcomes in Pediatrics
Official title: A Multisite RWCT Comparing the Effectiveness of a Goals of Care Video and Navigator Intervention, the VIDEO-PEDS Experience, Versus Usual Care in Pediatric Cancer
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Pediatric Cancer
Keywords: Advanced Care Planning
Palliative Care
End of Life
Lead sponsor: Massachusetts General Hospital
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
name: Dartmouth-Hitchcock Medical Center
name: Dana-Farber Cancer Institute
name: Yale University
name: Emory University
name: Children's Healthcare of Atlanta
name: University of Alabama at Birmingham
First posted: 2025-01-22
Enrollment: 567
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention model description: The initial development and pilot phase is not randomized and the latter RWCT phase is 1:1 parallel randomized arms.
Primary purpose: SUPPORTIVE_CARE

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)?

Detailed description: 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

1. To refine and finalize a theory-based video decision aid tailored to parents of children with advanced cancer.
2. To evaluate the feasibility, acceptability, and preliminary impact of the intervention through a pilot study.
3. To conduct a randomized waitlist-controlled trial (RWCT) assessing the effectiveness of the intervention in improving GOC communication and documentation.

Design

This study will be conducted in two phases:

1. Pilot Study

   * Design: A mixed-methods study to test the feasibility and acceptability of the intervention among 27 parents (9 per site). Focus groups with 36 parents (12 per site) will be conducted in English and Spanish. Clinician providers will be interviewed.
   * Purpose: To refine the intervention and ensure its appropriateness for the larger trial.
2. Randomized Waitlist-Controlled Trial (RWCT)

   * Design: A multicenter, parallel-group RCT with a waitlist control.
   * Purpose: To evaluate the impact of the intervention on GOC documentation and patient- and parent-centered outcomes.

Setting

The study will take place across three diverse healthcare systems:

1. Dana-Farber Cancer Institute/Boston Children's Hospital
2. Children's Healthcare of Atlanta/Aflac Cancer Center
3. University of Alabama at Birmingham These sites were selected because of their robust pediatric oncology programs and diverse patient populations, including African American, Hispanic, and rural families.

Participants/Subjects

1. Pilot Study:

   Parents of 27 children (9 per site) aged 0-12 years with cancer will be recruited to test the intervention.
2. RWCT:

   * A total of 504 parents (168 per recruitment cycle across three cycles) will be enrolled.
   * Stratification will ensure representation of African American, Hispanic, and rural populations.

Interventions

1. Pilot Study:

   * Intervention: A video decision aid coupled with structured conversations facilitated by trained Navigators. The video provides education about GOC, focusing on values-based decision-making and specific interventions (e.g., CPR, intubation).
   * Duration: Parents will view the video and engage in one or more conversations with the Navigator over three months.
2. RWCT:

   * Intervention: Refined video decision aid with Navigator-led discussions over a nine-month period.
   * Control: Usual care, with the intervention provided to the waitlist control group after nine months.

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:

* Parent focus groups led by site PIs will be held in English and Spanish via Zoom and audio recorded. The video will be shown and discussed following a semi-structured guide.
* The video will be refilmed to incorporate feedback from the focus groups.
* Workflows will be refined and study infrastructure will be developed further for the next 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:

* Mixed-methods process evaluation will use the RE-AIM framework to assess implementation.
* Descriptive statistics will be used for feasibility outcomes (e.g., recruitment, and retention rates).
* Comparative analysis of primary and secondary outcomes between intervention and control groups using intention-to-treat principles.
* Natural Language Processing technology will be used to identify outcomes in the EHR.

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:

* Implementation outcomes: Feasibility, acceptability, and fidelity of the intervention.
* Parent-reported outcomes: Satisfaction with communication, perceived knowledge, and decisional certainty.
* Patient outcomes: Location of care at the end of life, alignment of care with stated goals.

Exploratory analyses will examine subgroup effects among African American, Hispanic, and rural participants, as well as the cost-effectiveness and scalability of the intervention.

Eligibility criteria: Inclusion Criteria:

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.
* Has a child meeting the child inclusion criteria listed above.
* Able to communicate in English or Spanish (the languages of the video decision aids).

Exclusion Criteria:

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

* 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).
* 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

Primary outcomes:
measure: Goals-of-Care Discussion
timeFrame: At the end of Cycles 1, 2, and 3 (each cycle is 9 months)
measure: Code Status Limitation
timeFrame: At the end of Cycles 1, 2, and 3 (each cycle is 9 months)
measure: Palliative Care
timeFrame: At the end of Cycles 1, 2, and 3 (each cycle is 9 months)
measure: Time-Limited Trial
timeFrame: At the end of Cycles 1, 2, and 3 (each cycle is 9 months)
Secondary outcomes:
measure: Acceptability themes from qualitative data
timeFrame: 2 years
measure: Feasibility by % of parents
timeFrame: 2 years
measure: Parent Satisfaction scores
timeFrame: 2 years
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: Children's of Alabama at Birmingham
state: Alabama
city: Atlanta
country: United States
facility: Children's Hospital of Atlanta
state: Georgia
city: Boston
country: United States
facility: Dana Farber Cancer Institute
state: Massachusetts
city: Lebanon
country: United States
facility: Dartmouth Hitchcock Medical Center
state: New Hampshire
Study officials:
affiliation: Dartmouth-Hitchcock Medical Center
name: Angelo Volandes, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.