VIDEO-PEDS for Pediatric Cancer

(VIDEO-PEDS Trial)

Recruiting at 3 trial locations

Overseen By Joanne E Wolfe, MD

Age: Any Age

Sex: Any

Trial Phase: Academic

Sponsor: Massachusetts General Hospital

Disqualifiers: Palliative care, Life expectancy, Vision, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

567 Participants Needed

Trial Summary

What is the purpose of 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)?

Do I have to stop taking my current medications for the trial?

The trial information does not specify whether you need to stop taking your current medications. It seems focused on communication and decision-making rather than medication changes.

What safety data exists for the treatment VIDEO-PEDS in pediatric cancer trials?

The research highlights the importance of accurately reporting adverse events (side effects) in pediatric cancer trials to understand treatment safety. It also emphasizes the need for collecting symptom and adverse event data directly from children to ensure comprehensive safety monitoring. ^{1 2 3 4 5}

Research Team

Angelo Volandes, MD

Principal Investigator

Dartmouth-Hitchcock Medical Center

Eligibility Criteria

This trial is for parents of children with cancer. It's designed to see if a new tool, VIDEO-PEDS, helps improve communication about care goals between doctors and parents. Parents must be able to participate in discussions and focus groups.

Inclusion Criteria

I am under 13 and am being treated for cancer.

I am the main decision maker for my child's health and can communicate in English or Spanish.

Exclusion Criteria

Patient not receiving primary medical care from the cancer clinic, already referred to and fully consulted by the palliative care team, or with a prognosis of less than a 2-month life expectancy

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Pilot Study

A mixed-methods study to test the feasibility and acceptability of the intervention among parents, including focus groups and clinician interviews

3 months

Multiple visits for focus groups and interviews

Randomized Waitlist-Controlled Trial (RWCT)

A multicenter, parallel-group RCT with a waitlist control to evaluate the impact of the intervention on GOC documentation and patient- and parent-centered outcomes

9 months per cycle, 27 months total

Regular visits for intervention and control group activities

Follow-up

Participants are monitored for safety and effectiveness after treatment, including surveys and interviews

9 months

Surveys and interviews at the end of each cycle

Treatment Details

Interventions

• VIDEO-PEDS

Trial Overview The study tests the effectiveness of VIDEO-PEDS—a video-based intervention—against usual care practices in pediatric cancer settings. It looks at whether this approach betters documentation, patient outcomes like less aggressive treatments, and parent satisfaction.

Participant Groups

Group I: UH3 RWCT Arm - Intervention Experimental Treatment 1 Intervention

This group will receive the VIDEO-PEDS intervention.

Group II: UG3 Pilot Intervention Experimental Treatment 1 Intervention

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

Group III: UG3 Focus Group Experimental Treatment 1 Intervention

This group will participate in the virtual parent focus groups.

Group IV: UH3 RWCT Arm - Control Active Control 1 Intervention

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

Who Is Running the Clinical Trial?

Massachusetts General Hospital

Lead Sponsor

Trials

3,066

Recruited

13,430,000+

Emory University

Collaborator

Trials

1,735

Recruited

2,605,000+

Dartmouth-Hitchcock Medical Center

Collaborator

Trials

548

Recruited

2,545,000+

Dana-Farber Cancer Institute

Collaborator

Trials

1,128

Recruited

382,000+

University of Alabama at Birmingham

Collaborator

Trials

1,677

Recruited

2,458,000+

Children's Healthcare of Atlanta

Collaborator

Trials

172

Recruited

108,000+

National Cancer Institute (NCI)

Collaborator

Trials

14,080

Recruited

41,180,000+

Yale University

Collaborator

Trials

1,963

Recruited

3,046,000+

Findings from Research

The study demonstrated that it is feasible and acceptable to collect self-reported symptoms, function, and quality of life (QOL) data from pediatric cancer patients aged 8 to 18 enrolled in phase 1/2 clinical trials, with a high enrollment rate of 75.9%.

The findings indicated that while most measures were reliable, the validity of the results was limited; specifically, as adverse events increased, patients reported decreased mobility and increased fatigue, suggesting that patient-reported outcomes could serve as valuable endpoints in clinical trials.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Voices of children and adolescents on phase 1 or phase 2 cancer trials: A new trial endpoint? Hinds, PS., Wang, J., Stern, ED., et al.[2020]

Adverse event (AE) reporting in pediatric acute myeloid leukemia trials often underestimates the actual rates, with sensitivity for many AEs being less than 50%, indicating a need for improved reporting methods.

Using external electronic data sources, like Pediatric Health Information System (PHIS) billing and microbiology data, significantly enhances the accuracy of AE detection, particularly for specific toxicities such as viridans group streptococcal bacteremia, which showed high sensitivity and positive predictive value.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Accuracy of Adverse Event Ascertainment in Clinical Trials for Pediatric Acute Myeloid Leukemia. Miller, TP., Li, Y., Kavcic, M., et al.[2020]

In a South African pediatric intensive care unit (PICU), a retrospective audit identified a high rate of adverse events (50.8 per 100 patient days) among 80 patients, with catheter complications and hypoglycemia being the most common issues.

The study found that real-time registration during ward rounds reported a lower rate of adverse events (27.2 per 100 patient days) among 236 patients, highlighting that different registration methods can yield varying insights into patient safety and types of adverse events.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Patient safety in South Africa: PICU adverse event registration*. Vermeulen, JM., van Dijk, M., van der Starre, C., et al.[2014]

The Pediatric Terminology Harmonization Initiative developed a comprehensive adverse event (AE) terminology specifically for pediatric care, containing over 1000 terms related to pediatric diseases and disorders, to improve international reporting and understanding of AEs.

This new terminology is designed for easy integration with existing biomedical vocabularies and is applicable in various healthcare settings, making it a valuable resource for enhancing pediatric clinical research and safety reporting.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Development of a Pediatric Adverse Events Terminology. Gipson, DS., Kirkendall, ES., Gumbs-Petty, B., et al.[2019]

References

1. United States pubmed.ncbi.nlm.nih.gov

Voices of children and adolescents on phase 1 or phase 2 cancer trials: A new trial endpoint? [2020]

2. United States pubmed.ncbi.nlm.nih.gov

Recommended scoring approach for the pediatric patient-reported outcomes version of the Common Terminology Criteria for Adverse Events. [2023]

3. United States pubmed.ncbi.nlm.nih.gov

Accuracy of Adverse Event Ascertainment in Clinical Trials for Pediatric Acute Myeloid Leukemia. [2020]

4. United States pubmed.ncbi.nlm.nih.gov

Patient safety in South Africa: PICU adverse event registration*. [2014]

5. United States pubmed.ncbi.nlm.nih.gov

Development of a Pediatric Adverse Events Terminology. [2019]