Assessing and Addressing Health-Related Social Needs Among Families of Children With Cancer
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorWake Forest University Health Sciences
About this trial
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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
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.
Disqualifiers
There are no specific exclusion criteria.
Trial 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.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Community Enhancing Resources for Childhood cAncer support (CERCA)
Other interventionCERCA 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.
Treatment groups
60 Participants
are divided into 1 treatment groupGroup A: Caregivers, Community-Based Organizations, and Healthcare Professionals1 intervention
Trial outcomes
Primary outcomes
1
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
Time frame
Baseline2
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.
Time frame
Approximately 10 months after study initiationSecondary outcomes
1
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).
Time frame
Approximately 15 months after study initiationSponsors and contacts
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Wake Forest University Health Sciences
Lead sponsor
Atrium Health Levine Cancer Institute
Collaborator
National Center for Advancing Translational Sciences (NCATS)
Collaborator
Source ClinicalTrials.gov