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Recruiting NCT07278414

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

Observational Childhood Cancers Caregiver Social Support Caregiver Distress Social Needs

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Community Enhancing Resources for Childhood cAncer support (CERCA).
Who it may be relevant to
Registry conditions: Childhood Cancers, Caregiver Social Support, Caregiver Distress, Social Needs. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

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

Overview

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.

Interventions

  • 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.

Primary outcome measures

  • Unmet Health-Related Social Needs (HRSN) [Time frame: Baseline]
  • Processes of HRSN screening and referrals [Time frame: Approximately 10 months after study initiation]
Secondary outcome measures (1)
  • To develop CERCA (Community Enhancing Resources for Childhood cAncer support) [Time frame: Approximately 15 months after study initiation]

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.

Exclusion criteria

  • There are no specific exclusion criteria.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Observational model
Cohort

Study locations

United States · 1 center
  • Atrium Health Wake Forest Baptist Comprehensive Cancer Center — Winston-Salem

Identifiers

NCT: NCT07278414 · IRB00138352 · 1K12TR004931-01 · ONC-PED-2501 · NCI-2025-08622

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗