Assessing and Addressing Health-Related Social Needs Among Families of Children With Cancer

Developing and Refining an Intervention to Assess and Address Health-Related Social Needs Among Families of Children With Cancer

The purpose of this study is to design Community Enhancing Resources for Childhood cAncer support (CERCA) and refine intervention procedures to target Health-related Social Needs (HRSN) in families of children with cancer. CERCA will leverage existing community resources and create partnerships that will lead to sustainable outcomes. The hypothesis is that through context-driven co-design and community-engaged research methods, the study team will develop an acceptable intervention to target unmet HRSN in families of children with cancer.

Study Overview

• Status: Recruiting
• Conditions: Caregiver Distress; Childhood Cancers; Caregiver Social Support; Social Needs
• Intervention / Treatment: Other: Community Enhancing Resources for Childhood cAncer support (CERCA)

Detailed Description

The first goal of this study is to identify unmet health-related social needs (HRSN) faced by families undergoing pediatric cancer care and identify health system and community resources to address these unmet HRSN. The second goal of this study is to conduct a context assessment of the current processes related to HRSN screening and referrals in the pediatric oncology clinic via individual interviews and clinical workflow observations with healthcare professionals and clinical staff in the pediatric oncology clinic.

Participants of this study will include caregivers of children in cancer care, representatives of community-based organizations that provide resources for families of children with cancer, and healthcare professionals. The study involves virtual or in-person interviews and co-design workshops and will not alter the treatment decisions made by the enrolling investigator or management of the participant's health.

• Study Type: Observational
• Enrollment (Estimated): 60

Contacts and Locations

• Study Contact: Name: Katherine Brinkley; Phone Number: 336-702-4483; Email: katherine.brinkley@advocatehealth.org

Study Locations

• United States
  • North Carolina
    • Winston-Salem, North Carolina, United States, 27157
      • Recruiting
      • Atrium Health Wake Forest Baptist Comprehensive Cancer Center
      • Contact: Katherine Brinkley; Phone Number: 336-702-4483; Email: katherine.brinkley@advocatehealth.org
      • Principal Investigator: Joanna M Robles, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

• Sampling Method: Non-Probability Sample

Study Population

Adults of all races and ethnicities of 18 years of age or more who meet the eligibility criteria are eligible to participate in this study. No participants will be excluded on the basis of their gender, race, or ethnicity.

Description

Inclusion Criteria:

Caregivers of Children with Cancer

• A caregiver of a child (<18 years old) actively receiving treatment or recently completed treatment (within the past 1 year prior to enrollment) for any type of cancer. A caregiver is defined as any individual involved in bringing the child to the clinic or providing care at home, the hospital, or other healthcare setting (e.g., parents, guardians, siblings, etc.).
• Ability to understand IRB-approved information sheet and willingness to provide consent.
• Age ≥ 18 years at the time of consent.
• Ability to understand the English and/or Spanish language.

Community-based Organizations

• Representative of community-based organizations that provide resources for families of children with cancer
• Ability to understand IRB-approved information sheet and willingness to provide consent.
• Age ≥ 18 years at the time of consent.
• Ability to understand English and/or Spanish language.

Healthcare Professionals

• Physicians, advanced practice practitioners, nurses, clinical social workers, medical assistants, clinic patient service representatives, and cancer center administrators at AHWFBC.
• Ability to understand IRB-approved information sheet and willingness to provide consent.
• Age ≥ 18 years at the time of consent.
• Ability to understand English and/or Spanish language.

Exclusion Criteria:

• There are no specific exclusion criteria.

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Caregivers, Community-Based Organizations, and Healthcare Professionals; Caregivers of children undergoing cancer care, representatives of community-based organizations that provide resources for families of children with cancer, and healthcare providers of children undergoing cancer care	Other: Community Enhancing Resources for Childhood cAncer support (CERCA); CERCA is a context-driven, co-designed intervention leveraging community resources to address unmet Health-related Social Needs (HRSN) among families of children with cancer. This study will observe the process of intervention development and assess acceptability and feasibility.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Unmet Health-Related Social Needs (HRSN)	Identification of unmet health-related social needs (HRSN) faced by families undergoing pediatric cancer care and identify health system and community resources to address these unmet HRSN	Baseline
Processes of HRSN screening and referrals	Context assessment of the current processes related to HRSN screening and referrals in the pediatric oncology clinic via individual interviews and clinical workflow observations with healthcare professionals and clinical staff in the pediatric oncology clinic.	Approximately 10 months after study initiation

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
To develop CERCA (Community Enhancing Resources for Childhood cAncer support)	The CERCA intervention will be co-designed with community-based organizations, caregivers, pediatric oncology healthcare professionals, and cancer center administration. These partners will work alongside the research team via three iterative workshops to: 1) refine the conceptual model for CERCA using data from individual interviews, 2) define intervention features, 3) identify context factors based on context assessment interviews/observations and 4) co-design a protocol of the intervention (e.g., content, decisions on design and tailoring of intervention, and materials).	Approximately 15 months after study initiation

Collaborators and Investigators

• Sponsor: Wake Forest University Health Sciences
• Collaborators: National Center for Advancing Translational Sciences (NCATS); Atrium Health Levine Cancer Institute
• Investigators: Principal Investigator: Joanna M Robles, MD, Wake Forest University Health Sciences

Study record dates

Study Major Dates

• Study Start (Actual): January 7, 2026
• Primary Completion (Estimated): January 1, 2027
• Study Completion (Estimated): June 1, 2027

Study Registration Dates

• First Submitted: December 1, 2025
• First Submitted That Met QC Criteria: December 1, 2025
• First Posted (Actual): December 12, 2025

Study Record Updates

• Last Update Posted (Actual): May 4, 2026
• Last Update Submitted That Met QC Criteria: April 27, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Keywords: Childhood Cancer; Social Needs; Caregiver Support
• Additional Relevant MeSH Terms: Neoplasms
• Other Study ID Numbers: IRB00138352; 1K12TR004931-01 (U.S. NIH Grant/Contract); ONC-PED-2501 (Other Identifier: Atrium Health); NCI-2025-08622 (Other Identifier: National Cancer Institute)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Qualitative data only

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No