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

NCT07278414 | Recruiting DMC

• 4 other identifiers: IRB001383521K12TR004931-01ONC-PED-2501NCI-2025-08622
• Study Type: observational
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Caregiver Distress; Social Needs; Childhood Cancers; Caregiver Social Support

Keywords

Social Needs; Caregiver Support; Childhood Cancer

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (1)

• To develop CERCA (Community Enhancing Resources for Childhood cAncer support)

  Approximately 15 months after study initiation

Study Arms (1)

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)

Interventions

Community Enhancing Resources for Childhood cAncer support (CERCA) OTHER

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.

Caregivers, Community-Based Organizations, and Healthcare Professionals

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

Sponsors & Collaborators

• National Center for Advancing Translational Sciences (NCATS): collaborator
• Atrium Health Levine Cancer Institute: collaborator
• Wake Forest University Health Sciences: lead

Study Sites (1)

Atrium Health Wake Forest Baptist Comprehensive Cancer Center

Winston-Salem, North Carolina, 27157, United States

RECRUITING

MeSH Terms

Conditions

Neoplasms

Study Officials

• Joanna M Robles, MD

  Wake Forest University Health Sciences

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Katherine Brinkley

CONTACT

336-702-4483; katherine.brinkley@advocatehealth.org

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 1, 2025
• First Posted: December 12, 2025
• Study Start: January 7, 2026
• Primary Completion (Estimated): January 1, 2027
• Study Completion (Estimated): June 1, 2027
• Last Updated: May 4, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)