Childhood CancersNCT07278414
Assessing and Addressing Health-Related Social Needs Among Families of Children With Cancer
An observational study of Childhood Cancers and Caregiver Social Support, run by Wake Forest University Health Sciences at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Childhood Cancers, Caregiver Social Support, Caregiver Distress
- What is being tested?
- Community Enhancing Resources for Childhood cAncer support (CERCA)
- How many people
- 60 participants
- Where
- 1 siteUnited States
- Study dates
- 7 Jan 2026to Jun 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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.
Who may be able to join
- 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
Show all 15Show fewer
- 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.
Who cannot join
- There are no specific exclusion criteria.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Atrium Health Wake Forest Baptist Comprehensive Cancer Center
Winston-Salem, North Carolina, 27157
Katherine Brinkley, 336-702-4483, katherine.brinkley@advocatehealth.org
Joanna M Robles, MD
About this study
Official title: Developing and Refining an Intervention to Assess and Address 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.
Read the 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.
- Being tested
- Community Enhancing Resources for Childhood cAncer support (CERCA)
- Keywords
- Social Needs, Caregiver Support, Childhood Cancer
- Medical subject headings
- Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Other: Community Enhancing Resources for Childhood cAncer support (CERCA) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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.
Measured: Approximately 10 months after study initiation
Secondary 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).
Measured: Approximately 15 months after study initiation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Dec 2025
- Study start7 Jan 2026
- Primary completionJan 2027 (estimated)
- Study completionJun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Childhood CancersStudies of the same condition, open and under way.
- More trials run by Wake Forest University Health SciencesThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Wake Forest University Health Sciences
- Sponsor type
- University, hospital or other
- Collaborators
- Atrium Health Levine Cancer Institute, National Center for Advancing Translational Sciences (NCATS)
- Responsible party
- Sponsor
- Investigators
- Joanna M Robles, MD, Principal investigator, Wake Forest University Health Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07278414
- Sponsor's protocol ID
- IRB00138352
- Other IDs
- 1K12TR004931-01, ONC-PED-2501, NCI-2025-08622
- Status last verified
- Jul 2026
- First submitted
- 1 Dec 2025
- Last updated
- 17 Jul 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Qualitative data only
Study at a glance
From the registry record, last updated by the sponsor on 17 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Developing and Refining an Intervention to Assess and Address Health-Related Social Needs Among Families of Children With Cancer
- ClinicalTrials.gov ID
- NCT07278414
- Acronym / sponsor ID
- IRB00138352
- Keywords
- Social Needs, Caregiver Support, Childhood Cancer
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Wake Forest University Health SciencesUniversity, hospital or other
- Collaborators
- Atrium Health Levine Cancer Institute, National Center for Advancing Translational Sciences (NCATS)
- Study start
- 7 Jan 2026 (actual)
- Primary completion
- Jan 2027 (estimated)
- Study completion
- Jun 2027 (estimated)
- First posted
- 12 Dec 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Caregivers, Community-Based Organizations, and Healthcare Professionals | – | Other: Community Enhancing Resources for Childhood cAncer support (CERCA)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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (15 listed)
- 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.
Key exclusion criteria (1 listed)
- There are no specific exclusion criteria.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Other | Caregivers, Community-Based Organizations, and Healthcare Professionals |
Primary outcome
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
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.
1 secondary outcome
To develop CERCA (Community Enhancing Resources for Childhood cAncer support)
Time frame: Approximately 15 months after study initiation
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jul 2026.
- Individual participant dataSharing planned: No. Qualitative data only
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Joanna M Robles, MD principal investigator
Wake Forest University Health Sciences
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Childhood Cancers and Caregiver Social Support, run by Wake Forest University Health Sciences at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 15 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 17 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Hiral Amin (704-446-4838, Hiral.Amin@advocatehealth.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Unmet Health-Related Social Needs (HRSN) (time frame: Baseline). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Jul 2026.