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

NCT ID: NCT07278414

Last Updated: 2026-01-08

Basic Information

• Recruitment Status: RECRUITING
• Total Enrollment: 60 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2026-02-28
• Study Completion Date: 2027-06-30

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.

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.

Conditions

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

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

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

Community Enhancing Resources for Childhood cAncer support (CERCA)

Intervention Type: 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.

Interventions

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.

Intervention Type: OTHER

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Atrium Health Levine Cancer Institute

OTHER

Sponsor Role: collaborator

National Center for Advancing Translational Sciences (NCATS)

NIH

Sponsor Role: collaborator

Wake Forest University Health Sciences

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Joanna M Robles, MD

Role: PRINCIPAL_INVESTIGATOR

Wake Forest University Health Sciences

Locations

Atrium Health Wake Forest Baptist Comprehensive Cancer Center

Winston-Salem, North Carolina, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Katherine Brinkley

Role: CONTACT

katherine.brinkley@advocatehealth.org

336-702-4483

Facility Contacts

Katherine Brinkley

Role: primary

katherine.brinkley@advocatehealth.org

336-702-4483

Other Identifiers

1K12TR004931-01

Identifier Type: NIH

Identifier Source: secondary_id

View Link

ONC-PED-2501

Identifier Type: OTHER

Identifier Source: secondary_id

NCI-2025-08622

Identifier Type: OTHER

Identifier Source: secondary_id

IRB00138352

Identifier Type: -

Identifier Source: org_study_id