Implementation of Family Psychosocial Risk Assessment in Pediatric Cancer

NCT04446728 | Active Not Recruiting

• 1 other identifier: AK001
• Study Type: interventional
• Target: 18
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Pediatric Cancer

Keywords

Families; Psychosocial; Health equity

Outcome Measures

Primary Outcomes (9)

• Families screened

  Number of families screened divided by number of families eligible

  At conclusion of cohort year (12 months post baseline)

• Site Participation Rate

  Number of sites that completed the study divided by sites enrolled

  At conclusion of the study (12 months post baseline)

• Families provided feedback

  Number of families provided feedback divided by number of families screened

  At conclusion of cohort year (12 months post baseline)

• Ethnic minority families screened

  Number of ethnic minority families screened divided by number of ethnic minority families eligible

  At conclusion of cohort year (12 months post baseline)

• Physician Engagement in Addressing Racial and Ethnic Health Care Disparities (AREA) scale

  Changes in level of engagement in addressing health disparities as measured by the AREA, a 9 point scale with a 5 point likert response. Total scores range from 0 to 36 with higher scores indicating higher level of engagement

  Baseline, 6 and 12 months

• Maslach Burnout Inventory (MBI)

  Changes in burnout measured with this 22 item scale with a items on a 7 point Likert scale, higher scores indicate higher job satisfaction. Range of scores is from 0 to 42.

  Baseline, 6 and 12 months

• Acceptability of Intervention Measure (AIM)

  Changes in acceptability of the PAT using this four item survey on a 5 point likert scale; range of scores is from 5 to 25; higher score is higher acceptability

  Baseline, 6 months, 12 months

• Intervention Appropriateness Measure (IAM)

  Changes in perceived appropriateness of the PAT using this four item survey on a 5 point likert scale; range of scores is from 5 to 25; higher score is higher appropriateness

  Baseline, 6 months, 12 months

• Feasibility of Intervention Measure (FIM)

  Changes in perceptions of the feasibility of using the PAT measured with this four item survey on a 5 point likert scale; range of scores is from 5 to 25; higher score is higher feasibility

  Baseline, 6 months, 12 months

Study Arms (2)

Strategy I.Training

ACTIVE COMPARATOR

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

Behavioral: Training Webinar

Strategy II.Training+Implementation Enhanced Resources (TIER)

ACTIVE COMPARATOR

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.

Behavioral: Training Webinar; Behavioral: Training Webinar Plus Implementation Enhanced Resources (TIER)

Interventions

Training Webinar BEHAVIORAL

The training webinar is a three hour training. The purpose of the study is to implement the Psychosocial Assessment Tool (PAT) in their center.

Strategy I.Training; Strategy II.Training+Implementation Enhanced Resources (TIER)

Training Webinar Plus Implementation Enhanced Resources (TIER) BEHAVIORAL

In addition the Training Webinar, sites randomized to Strategy II will identify a Champion and will participate in monthly consultation calls in support of implementation of the PAT

Strategy II.Training+Implementation Enhanced Resources (TIER)

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Sites were selected in advance based on data collected in a previous study regarding psychosocial staffing in the pediatric cancer program.
• Sites that were at or above the median for size of their psychosocial staff were eligible. - --
• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Nemours Children's Clinic: lead
• Children's Hospital of Philadelphia: collaborator
• American Cancer Society, Inc.: collaborator

Study Sites (1)

Nemours Children's Health

Wilmington, Delaware, 19083, United States

Location

Related Publications (4)

• Barakat LP, Scialla MA, Ramaswamy N, Deatrick JA, Arasteh K, Sandler E, Hammer SN, Kazak AE. A comparative effectiveness trial for universal psychosocial screening with the Psychosocial Assessment Tool (PAT) across 18 childhood cancer programs in the United States: adoption, penetration, and health equity. Implement Sci. 2026 Feb 26. doi: 10.1186/s13012-026-01493-4. Online ahead of print.

  PMID: 41742161 DERIVED

• Deatrick JA, Kazak AE, Scialla MA, Madden RE, McDonnell GA, Okonak K, Barakat LP. Advancing health equity in pediatric cancer through implementation of universal family psychosocial risk screening. Psychooncology. 2022 Sep;31(9):1483-1490. doi: 10.1002/pon.5978. Epub 2022 Jul 1.

  PMID: 35726382 DERIVED

• Deatrick JA, Kazak AE, Madden RE, McDonnell GA, Okonak K, Scialla MA, Barakat LP. Using qualitative and participatory methods to refine implementation strategies: universal family psychosocial screening in pediatric cancer. Implement Sci Commun. 2021 Jun 5;2(1):62. doi: 10.1186/s43058-021-00163-4.

  PMID: 34090525 DERIVED

• Kazak AE, Deatrick JA, Scialla MA, Sandler E, Madden RE, Barakat LP. Implementation of family psychosocial risk assessment in pediatric cancer with the Psychosocial Assessment Tool (PAT): study protocol for a cluster-randomized comparative effectiveness trial. Implement Sci. 2020 Jul 29;15(1):60. doi: 10.1186/s13012-020-01023-w.

  PMID: 32727493 DERIVED

MeSH Terms

Conditions

Neoplasms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: This is an implementation trial in which institutions are assigned to conditions. There is no masking.
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Center Director

Study Record Dates

• First Submitted: June 2, 2020
• First Posted: June 25, 2020
• Study Start: January 1, 2021
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: December 30, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: At conclusion of study
• Access Criteria: Data sharing will be considered with clinical leaders, investigators, policy makers and cancer advocates interested in implementation strategies for psychosocial screening and care.

Locations

US (1)