VIDEO-PEDS for Pediatric Cancer

(VIDEO-PEDS Trial)

Not yet 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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores a new method to help doctors and parents communicate more effectively about care goals for children with cancer. It aims to determine if the VIDEO-PEDS intervention, a communication tool, can improve the recording of care preferences, enhance patient and parent experiences, and lead to more appropriate care choices, such as palliative or hospice care. The trial includes different groups: those receiving a full or pilot version of the intervention and those receiving standard care. Families with children aged 0-12 years who are undergoing cancer treatment and meet specific criteria may be eligible. As an unphased trial, this study provides families the opportunity to contribute to innovative communication strategies that could significantly improve care experiences.

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 prior data suggests that the VIDEO-PEDS intervention is safe for pediatric cancer patients?

Research shows that technology-based tools like VIDEO-PEDS can enhance the health and well-being of children with cancer. These tools boost both physical and emotional health and assist parents in managing their child's illness. Although these tools are generally easy to use, studies do not clearly outline possible side effects. However, since VIDEO-PEDS is a non-invasive tool focused on communication, major safety issues are unlikely. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the VIDEO-PEDS trial because it explores an innovative method to enhance treatment for pediatric cancer patients. Unlike traditional treatments that primarily focus on chemotherapy, radiation, or surgery, VIDEO-PEDS is a digital intervention designed to support young patients and their families through virtual engagement. This approach aims to improve the overall treatment experience by offering emotional support and education, potentially leading to better adherence to medical regimens and improved quality of life. By integrating technology into care, researchers hope to provide more holistic support tailored to the unique needs of pediatric cancer patients.

What evidence suggests that the VIDEO-PEDS intervention is effective for improving communication in pediatric cancer care?

Research has shown that technology-based tools, such as VIDEO-PEDS, can enhance communication and outcomes in children's cancer care. This trial will assign participants to different arms to evaluate VIDEO-PEDS's effectiveness. Studies have found that video game interventions in similar contexts can help children adhere to treatment plans and better understand and manage their condition. One study noted improvements in both physical and emotional symptoms in children and also helped parents cope more effectively. Additionally, telehealth and interactive video games are promising tools for improving therapy results. These findings suggest that VIDEO-PEDS could positively impact discussions about care goals and related outcomes in pediatric cancer. ^{1 2 3 6 7}

Who Is on the Research Team?

Angelo Volandes, MD

Principal Investigator

Dartmouth-Hitchcock Medical Center

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11545673/

The Impact of Interactive Video Games Training on ... Results: The study included 21 patients (7–13 years old; 12 boys and 9 girls) treated for acute lymphoblastic leukemia (n = 13) and acute ...

2. publications.aap.org publications.aap.org/pediatrics/article/122/2/e305/73051/A-Video-Game-Improves-Behavioral-Outcomes-in

A Video Game Improves Behavioral Outcomes in ... The video-game intervention significantly improved treatment adherence and indicators of cancer-related self-efficacy and knowledge in ...

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11040188/

A Systematic Review of Telehealth-Based Pediatric Cancer ... Telehealth-based rehabilitation interventions for pediatric cancer survivors is an emerging research area with potential to improve disability outcomes.

4. sciencedirect.com sciencedirect.com/science/article/pii/S2347562523000379

The effect of technology-based interventions on child and ... Technology-based interventions have been effective in improving physical and psychological symptoms in children with cancer, and parents' coping and ...

5. bmjpaedsopen.bmj.com bmjpaedsopen.bmj.com/content/8/1/e002679

Development and testing of a videogame intervention for ... This study aims to develop a videogame intervention for children with cancer and test the clinical efficacy of the videogame concerning HRQOL ...

6. cancer.jmir.org cancer.jmir.org/2023/1/e45037

Effects of Active Video Games in Patients With Cancer AVG interventions improved endurance, quality of life, cancer-related fatigue, and self-efficacy. Effects were mixed on strength, physical function, and ...

7. frontiersin.org frontiersin.org/journals/pediatrics/articles/10.3389/fped.2018.00069/full

A Prototype Exercise–Empowerment Mobile Video Game ... A prototype Empower Stars! mobile video game was developed for children 7–14 years old with cancer. Active, sedentary, educational, and empowerment-centered ...