Psychosocial Support Interventions for Pediatric Cancer

(PAT Trial)

Overseen By Anne Kazak, Ph.D.

Age: Any Age

Sex: Any

Trial Phase: Academic

Sponsor: Nemours Children's Clinic

Disqualifiers: Low psychosocial staffing

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

Compensation: Varies

Number of Visits: 1

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores the best ways to provide psychosocial support to families dealing with pediatric cancer. It tests two methods of implementing a tool to identify families' emotional and social needs from diagnosis. The aim is to ensure families receive the right support early, potentially improving overall outcomes. Pediatric cancer centers with strong support staff, particularly those serving many Spanish-speaking or low-income families, are involved in the trial. As an unphased study, this trial allows families to contribute to research that could enhance support systems for future patients.

Will I have to stop taking my current medications?

The trial information does not specify whether participants need to stop taking their current medications.

What prior data suggests that these psychosocial support interventions are safe for pediatric cancer patients and their families?

Research shows that psychosocial support, like that offered in this study, is generally safe for children with cancer. These programs help families manage emotional and social challenges during treatment. Although specific safety data for the training webinar or extra resources in this trial is unavailable, they are non-invasive and focus on education and support, making them usually well-tolerated.

The training webinars assist care centers in using a tool to identify families' emotional and social needs. This type of support is common and has been implemented in many places without reports of harm. The extra resources provide additional ways for centers to offer this support effectively.

Overall, these programs focus on providing information and support, not involving medical procedures or medications, which means they carry very low risk. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about these psychosocial support interventions for pediatric cancer because they focus on enhancing the way care centers implement psychosocial assessments. Unlike traditional methods that might rely on standard training, these interventions introduce a structured training webinar and an additional approach called TIER, which includes ongoing monthly consultation calls and designating a Champion for screening. This approach aims to streamline and enhance the implementation process of psychosocial assessments, potentially leading to more effective and consistent support for young cancer patients across different care centers. By improving how centers adopt these assessments, researchers hope to boost emotional and psychological support for children, which is crucial alongside their medical treatment.

What evidence suggests that these psychosocial support interventions could be effective for pediatric cancer?

Research has shown that programs focusing on emotional and social support can greatly benefit children with cancer and their families. One study found that family-focused programs were popular and effective, with 76% of participants experiencing positive results. In this trial, some sites will receive the Training Webinar to help centers use the Psychosocial Assessment Tool (PAT) to better support families. Other sites will receive the Training Webinar Plus Implementation Enhanced Resources (TIER), which offers additional support and planning, making it easier for centers to use the PAT effectively. Both approaches aim to improve emotional and social care, leading to better health and emotional outcomes for patients and their families. ^{1 4 6 7 8}

Are You a Good Fit for This Trial?

This trial is for pediatric cancer programs in the U.S. that have a psychosocial staff size at or above the median level. Eligible sites must serve a significant number of new pediatric cancer patients, including Spanish speakers and families with low socioeconomic status.

Inclusion Criteria

Sites that were at or above the median for size of their psychosocial staff were eligible.

Sites were selected in advance based on data collected in a previous study regarding psychosocial staffing in the pediatric cancer program.

Site selection took into consideration number of new pediatric cancer patients annually, geographical representation and sites with significant proportions of Spanish speaking families and/or families of low socioeconomic status.

Exclusion Criteria

Sites with psychosocial staffing below the median in the prior study were not eligible.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Training and Implementation

Sites participate in a 3-hour training webinar and develop an implementation plan for the Psychosocial Assessment Tool (PAT).

3 hours

1 visit (virtual)

Implementation

Implementation of the PAT across 18 pediatric cancer programs, with sites randomized to different strategies. Strategy I involves training and technical support, while Strategy II includes additional resources and consultation calls.

12 months

Monthly consultation calls for Strategy II

Follow-up

Participants are monitored for outcomes such as feasibility, engagement, and appropriateness of the PAT implementation.

12 months

What Are the Treatments Tested in This Trial?

Interventions

• Training Webinar
• Training Webinar Plus Implementation Enhanced Resources (TIER)

Trial Overview

The study compares two strategies to implement the Psychosocial Assessment Tool (PAT) across 18 pediatric cancer centers. One group will receive Training Webinar Plus Implementation Enhanced Resources (TIER), while another just gets a training webinar.

How Is the Trial Designed?

Group I: Strategy I.Training Active Control 1 Intervention

Sites randomized to Strategy I will receive a three hour training webinar in preparing for implementation of the PAT in their center.

Group II: Strategy II.Training+Implementation Enhanced Resources (TIER) Active Control 2 Interventions

Sites randomized to Strategy II will identify a Champion for screening and will participate in a monthly consultation call in addition to completing the three hour training webinar for implementing the PAT in their center.

Who Is Running the Clinical Trial?

Nemours Children's Clinic

Lead Sponsor

Trials

128

Recruited

18,000+

Children's Hospital of Philadelphia

Collaborator

Trials

749

Recruited

11,400,000+

American Cancer Society, Inc.

Collaborator

Trials

237

Recruited

110,000+

Published Research Related to This Trial

The eSCCIP/eSCCIP-SP digital health intervention aims to provide psychosocial support to parents and caregivers of children with cancer, combining self-guided web content with telehealth sessions, and is being tested in a randomized controlled trial with 350 participants.

The primary goal of the trial is to assess the intervention's effectiveness in reducing acute distress and improving coping skills, which could lead to a scalable and impactful treatment option for families affected by childhood cancer.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Electronic Surviving Cancer Competently Intervention Program-a Psychosocial Digital Health Intervention for English- and Spanish-Speaking Parents of Children With Cancer: Protocol for Randomized Controlled Trial. Canter, KS., Ritterband, L., Freyer, DR., et al.[2023]

A family-oriented psychosocial intervention program for pediatric cancer patients and their families was highly accepted and effective, as reported by 76 participating parents.

The program significantly improved information access and family communication, with factors like nationality, socioeconomic status, and cancer relapse influencing participation levels.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Parental assessment of a psycho-oncologic treatment concept in pediatrics]. Landolt, MA., Dangel, B., Twerenbold, P., et al.[2014]

Psychosocial support for children with cancer is crucial from the moment of diagnosis, with effective adaptation linked to the child's understanding of their situation and the emotional support from their family.

Research has shown that parental distress and available social supports significantly impact a child's adjustment to cancer treatment, highlighting the need for comprehensive support programs for both children and their families.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Psychosocial issues during the acute treatment of pediatric cancer. Koocher, GP.[2019]

Citations

1.

withpower.com

withpower.com/trial/phase-2021-07c7a

Psychosocial Support Interventions for Pediatric Cancer ...

A family-oriented psychosocial intervention program for pediatric cancer patients and their families was highly accepted and effective, as reported by 76 ...

2.

youtube.com

youtube.com/watch?v=C7fxYFJXDFc

Pre-Application Webinar: Improving Outcomes for Pediatric ...

This webinar provided a brief overview for potential applicants and addressed participants' questions about the NCI Funding Opportunity ...

3.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC8180116/

universal family psychosocial screening in pediatric cancer

Strategy I is a training webinar that addresses family psychosocial adjustment in pediatric cancer, pediatric psychosocial standards of care, the PPPHM ...

4.

youtube.com

youtube.com/watch?v=Ks3t__FF3Vw

FOA Webinar: Improving Outcomes for Pediatric, Adolescent ...

This webinar discussed RFA-CA-19-033, Improving Outcomes for Pediatric, Adolescent and Young Adult Cancer Survivors (U01 Clinical Trial ...

5.

childrenscancercause.org

childrenscancercause.org/webinars

Webinar Series — Children's Cancer Cause

This webinar was designed for childhood cancer advocates - beginners and experts alike - who want to learn more about effective advocacy practices. We heard ...

6.

youtube.com

youtube.com/watch?v=XMsBZCjEVAc

Survivor's Week Webinar: Childhood Cancer: A New Chapter ...

Looking after yourself - The emotional & psychological aspects of working in childhood cancer. International Society of Paediatric Oncology ...

7.

aspho.org

aspho.org/knowledge-center/products/webinars

Webinars · ASPHO

Led by dual-trained pediatric and adult hematologists with expertise in lifespan SCD care ... psychosocial support both prior to and after curative therapy. The ...

8.

cancer.gov

cancer.gov/research/areas/childhood/childhood-cancer-data-initiative/events-webinars

Childhood Cancer Data Initiative Events and Webinars

NCI hosts several events and webinars that provide updates on Childhood Cancer Data Initiative (CCDI) progress and next steps.