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

18 Participants Needed

Trial Summary

What is the purpose of this trial?

The diagnosis and treatment of pediatric cancer adversely affects multiple levels of the social ecology, including patient and caregiver physical and psychosocial health. It is the strong recommendation from the first Standard of the Psychosocial Standards of Care in Pediatric Cancer that cancer centers engage in universal, systematic, psychosocial risk screening for newly diagnosed patients and their families. Universal screening at diagnosis fosters early identification of psychosocial risks and provides the opportunity to match psychosocial care to the level of family need for more equitable, effective and integrated services. However, few programs offer such care in an efficient, comprehensive, and consistent manner, potentially resulting in insufficient care that magnifies inequities in outcomes. To support pediatric cancer centers in their goal of meeting the first Standard of Psychosocial Care, this study will compare two implementation strategies for the Psychosocial Assessment Tool (PAT), a validated parent report screener of family psychosocial risk in English and Spanish, in a cluster randomized trial across 18 pediatric cancer programs in the United States.

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 data supports the effectiveness of the treatment Training Webinar, Training Webinar Plus Implementation Enhanced Resources (TIER) for pediatric cancer?

Research shows that psychosocial interventions, like those in the TIER program, are effective in improving family communication and providing valuable information, which helps families cope better with pediatric cancer. Parents have reported high satisfaction with similar programs, noting positive effects on the entire family. ^{1 2 3 4 5}

Is the psychosocial support intervention for pediatric cancer safe?

The research does not provide specific safety data for the psychosocial support interventions, but these types of interventions generally focus on emotional and mental support, which are typically safe for participants. ^{2 6 7 8 9}

How is the psychosocial support treatment for pediatric cancer different from other treatments?

This treatment is unique because it focuses on providing emotional and social support to children with cancer and their families, rather than directly targeting the cancer itself. It involves screening for psychosocial risks and mapping these to specific resources, helping families manage mental health challenges like depression and anxiety during cancer treatment. ^{2 5 7 10 11}

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

References

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

Psychosocial needs of pediatric cancer patients and their caregivers at end of treatment: Why psychosocial screening remains important. [2023]

2. England pubmed.ncbi.nlm.nih.gov

Pilot randomized psychosocial trial of a screening intervention in pediatric oncology. [2022]

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

Standards for the Psychosocial Care of Children With Cancer and Their Families: An Introduction to the Special Issue. [2023]

4. Germany pubmed.ncbi.nlm.nih.gov

[Parental assessment of a psycho-oncologic treatment concept in pediatrics]. [2014]

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

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

6. Canada 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. [2023]

7. England pubmed.ncbi.nlm.nih.gov

The multidisciplinary pediatric psycho-oncology workforce: A national report on supervision for staff and training opportunities. [2020]

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

Delivery of care consistent with the psychosocial standards in pediatric cancer: Current practices in the United States. [2020]

9. Germany pubmed.ncbi.nlm.nih.gov

Psychosocial risk, symptom burden, and concerns in families affected by childhood cancer. [2022]

10. England pubmed.ncbi.nlm.nih.gov

Protocol for mapping psychosocial screening to resources in pediatric oncology: a pilot randomized controlled trial. [2022]

11. Turkey pubmed.ncbi.nlm.nih.gov

Turkish Validity and Reliability Study of Psychosocial Assessment Tool Oncology Version. [2023]