Skip to main content
OpenTrials
Recruiting

NCT Number: NCT07278414

Assessing and Addressing 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.

Recruiting

Interested in participating?

Request Info

Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Atrium Health Wake Forest Baptist Comprehensive Cancer Center

Winston-Salem, North Carolina, 27157, United States

Location status: Recruiting

Location contact

Joanna M Robles, MD

PRINCIPAL_INVESTIGATOR

Katherine Brinkley

CONTACT

[email protected]

336-702-4483

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

Primary outcomes

  1. Unmet Health-Related Social Needs (HRSN)

    Time frame: Baseline

    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

  2. Processes of HRSN screening and referrals

    Time frame: Approximately 10 months after study initiation

    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.

Secondary outcomes

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

    Time frame: Approximately 15 months after study initiation

    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).

Study contacts

Contact information is provided by the study sponsor or research team.

Hiral Amin

CONTACT

[email protected]

704-446-4838

Sponsors and collaborators

Lead sponsor

Wake Forest University Health Sciences

Other

Collaborators

  • Atrium Health Levine Cancer Institute
  • National Center for Advancing Translational Sciences (NCATS)

Registry information

Official study title

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

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Dec 12, 2025
Registry last updated
Jul 17, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.