CancerHRSNNCT06412029
Understanding and Enhancing Health-Related Social Needs (HRSN) Screening Among Community Oncology Practices
An observational study of Cancer, run by Wake Forest University Health Sciences at 38 sites in 3 countries.
Trial summary
This study evaluates health related social needs screening processes in community oncology clinics. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Cancer
- What is being tested?
- Non-Interventional
- How many people
- 144 participants
- Where
- 38 sitesin 3 countries
- Study dates
- 20 Nov 2024to 30 Aug 2028
- 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: NCI Community Oncology Research Program (NCORP) clinics
Who may be able to join
- Part 1
- NCORP PRACTICES:
- Must be an affiliate or sub-affiliate of an NCORP Community or Minority Underserved Community site
- Must provide outpatient oncology care
- Must be a NCORP practice (defined as one or more NCORP affiliates/sub-affiliates, that have a common administrative structure and share providers and/or patients)
- Must have identified two or more Practice Staff that are available and willing to participate on the Practice Interest Form
Show all 34Show fewer
- Must have identified at least 1-3 outpatient oncology clinics willing to participate on the Practice Interest Form
- CLINICS:
- 1-3 clinics within the practice should be selected
- Clinics may or may not be located in different physical locations
- The investigators will encourage NCORP practices to select clinics within a practice that differ in current or potential implementation of health related social needs (HRSN) screening (e.g., different clinic workflow or staff, different screening triggers, different tools), so that heterogeneity within NCORP practices can be captured
- Clinics must be willing to allow Practice Staff participants to observe the clinical operations in-person
- PRACTICE STAFF:
- Must be willing and able to take time to observe in person and document 1-3 selected clinics within the practice (approximately 2-3 hours per clinic)
- Must be staff at the selected and enrolled practice. Suggestions of appropriate staff are cancer care delivery research (CCDR) Lead, research nurse, clinical research coordinator or NCORP Administrators. Staff members with primary clinical roles may also be appropriate, if available
- Must be willing and able to participate in two 1.5 hour virtual training sessions
- Must be willing to interview Clinic Key Informants (approximately 30 minutes per interview; in-person or remotely over the internet or by phone)
- If the clinic is chosen for Part 2, must be willing to schedule an interview between Clinic Key Informant and Wake Forest health HRSN Study Team or designee
- If the clinic is chosen for Part 3, must be willing to participate in a three hour or two 1.5 hour in-person (if possible) workshop(s). If the clinic schedules an in-person workshop, there will be no hybrid or separate virtual option for those that cannot attend
- Must be willing to be recorded when participating in interviews and the workshop.
- CLINIC KEY INFORMANT:
- Must be willing to participate in Part 1 Operational Assessment, which involves a semi-structured interview (approximately 30 minutes; in-person or remotely over the internet or by phone) and a brief Non-patient Demographics Survey (approximately 5 minutes)
- If the clinic is chosen for Part 2, must be willing to participate in an additional 45 minute interview (remotely over the internet or by phone)
- If the clinic is chosen for Part 3, must be willing to participate in a three hour or two 1.5 hour in-person (if possible) workshop(s). If the clinic schedules an in-person workshop, there will be no hybrid or separate virtual option for those that cannot attend
- Part 3
- STAFF WORKSHOP PARTICIPANT:
- Must be a clinic stakeholder (e.g., providers, practice managers, etc.) of the selected clinic
- Must be willing and able to participate in a three hour or two 1.5 hour in-person (if possible) recorded workshop. If the clinic schedules an in-person workshop, there will be no hybrid or separate virtual option for those that cannot attend
- Must be willing to be recorded when participating in interviews and the workshop.
- PATIENT WORKSHOP PARTICIPANT:
- Must be a prospective clinic stakeholder (e.g., patient representative) of the selected clinic
- Must be willing and able to participate in a three hour or two 1.5 hour in-person (if possible) recorded workshop. If the clinic schedules an in-person workshop, there will be no hybrid or separate virtual option for those that cannot attend
- Must have received cancer treatment at the selected clinic within the last five years
- Must be willing to be recorded when participating in the workshop.
Who cannot join
- Part 1
- PRACTICE STAFF:
- Unable to understand, read and communicate in English, as the trainings and observations will be documented in English
- Part 3
- STAFF WORKSHOP PARTICIPANT:
- Unable to understand, read and communicate in English, as the workshop will be conducted in English
- PATIENT WORKSHOP PARTICIPANT:
- Unable to understand, read and communicate in English, as the workshop will be conducted in English
Trial locations and contacts
38 sites in 3 countries. Contact the study team or a site near you to ask about taking part.
38 sites in 3 countries
United States34 sites
Mission Cancer and Blood - Ankeny
Ankeny, Iowa, 50023
ThedaCare Regional Cancer Center
Appleton, Wisconsin, 54911
Central Care Cancer Center - Bolivar
Bolivar, Missouri, 65613
Essentia Health Saint Joseph's Medical Center
Brainerd, Minnesota, 56401
MaineHealth Cancer Care - Brunswick
Brunswick, Maine, 04011
Carle at The Riverfront
Danville, Illinois, 61832
Geisinger Medical Center
Danville, Pennsylvania, 17822
Iowa Methodist Medical Center
Des Moines, Iowa, 50309
Mission Cancer and Blood - Des Moines
Des Moines, Iowa, 50309
Mercy Medical Center - Des Moines
Des Moines, Iowa, 50314
Essentia Health Cancer Center
Duluth, Minnesota, 55415
Carle Physician Group-Effingham
Effingham, Illinois, 62401
Christiana Care - Union Hospital
Elkton, Maryland, 21921
Essentia Health Cancer Center-South University Clinic
Fargo, North Dakota, 58103
Cancer Hematology Centers - Flint
Flint, Michigan, 48503
Genesee Hematology Oncology PC
Flint, Michigan, 48503
Genesys Hurley Cancer Institute
Flint, Michigan, 48503
Aurora Cancer Care-Grafton
Grafton, Wisconsin, 53024
Prisma Health Cancer Institute - Butternut
Greenville, South Carolina, 29605
Prisma Health Cancer Institute - Faris
Greenville, South Carolina, 29605
Aurora Cancer Care-Kenosha South
Kenosha, Wisconsin, 53142
Carle Physician Group-Mattoon/Charleston
Mattoon, Illinois, 61938
Aurora Saint Luke's Medical Center
Milwaukee, Wisconsin, 53215
Hennepin County Medical Center
Minneapolis, Minnesota, 55415
University Medical Center New Orleans
New Orleans, Louisiana, 70112
NYP/Columbia University Medical Center/Herbert Irving Comprehensive Cancer Center
New York, New York, 10032
Helen F Graham Cancer Center
Newark, Delaware, 19713
Carle Cancer Institute Normal
Normal, Illinois, 61761
Illinois CancerCare-Peoria
Peoria, Illinois, 61615
FirstHealth of the Carolinas-Moore Regional Hospital
Pinehurst, North Carolina, 28374
Penobscot Bay Medical Center
Rockport, Maine, 04856
CoxHealth South Hospital
Springfield, Missouri, 65807
Carle Cancer Center
Urbana, Illinois, 61801
Wake Forest NCORP Research Base
Winston-Salem, North Carolina, 27157
Puerto Rico3 sites
Puerto Rico Hematology Oncology Group
Bayamón, 00961
Centro Comprensivo de Cancer de UPR
San Juan, 00927
San Juan City Hospital
San Juan, 00936
About this study
This study evaluates health related social needs screening processes in community oncology clinics.
Read the detailed description
The primary objective of this study is to assess current processes around health related social needs (HRSN) screening among NCORP clinics and categorize clinics based on their implementation of HRSN screening. The primary endpoint will be a detailed understanding of current processes, with attention to variability by key clinic characteristics.
There are 3 parts of the study in which participants can participate in one or all parts (3 total).
Part 1: Participants attend training, complete clinic assessments and observations and may complete an interview on study.
Part 2: Identified clinic staff will be interviewed to discuss factors that influence HRSN screening at their clinic and help develop generalized guidance.
Part 3: Participants attend a co-design workshop and complete surveys on study feasibility.
- Conditions
- Cancer
- Being tested
- Non-Interventional
- Keywords
- Cancer Health Disparities
- Medical subject headings
- Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Non-InterventionalOther
Non-interventional study
| Study group | Role | What they receive |
|---|---|---|
| Part 1 | Part 1: Participants attend training, complete clinic assessments and observations and may complete an interview on study. Receives: Other: Non-Interventional | |
| Part 2 | Part 2: Identified clinic staff will be interviewed to discuss factors that influence health related social needs (HRSN) screening at their clinic and help develop generalized guidance. Receives: Other: Non-Interventional | |
| Part 3 | Part 3: Participants attend a co-design workshop and complete surveys on study feasibility. Receives: Other: Non-Interventional |
What is being measured
The primary outcome is the main question the study is designed to answer.
HRSN screening reach (Part 1)
Determining the perception of the proportion of patients at clinics who are screened for health related social needs (HRSN).
Measured: From study enrollment to approximately 4 and 16 weeks post initial study training
Barriers and facilitators influencing HRSN screening implementation
Synthesize themes to create a list of barriers and facilitators influencing HRSN screening implementation within high-implementation clinics, moderate-implementation clinics, and low-implementation clinics.
Measured: From study enrollment to time completion of key informant interviews, approximately within 6 months
Generation of a tailored implementation plan for each participating clinic
Generation (defined for each clinic as completed or not completed) of a tailored implementation plan for each participating clinic in Part 3 that includes (1) adaptations to current HRSN screening and follow-up processes, and (2) potential implementation strategies to enhance HRSN screening implementation.
Measured: Between time of clinic selection and co-design workshop completion, to be no more than 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 May 2024
- Study start20 Nov 2024
- Primary completion30 Aug 2027 (estimated)
- Study completion30 Aug 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CancerStudies 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
- 144 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Wake Forest University Health Sciences
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Kathryn Weaver, PhD, Study chair, Wake Forest University Health Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06412029
- Sponsor's protocol ID
- IRB00113288
- Other IDs
- NCI-2024-02411, WF-2303CD, 5UG1CA189824
- Acronym
- HRSN
- Status last verified
- Oct 2026
- First submitted
- 7 May 2024
- Last updated
- 5 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Wake Forest NCORP Research Base is committed to following the NIH Statement on Sharing Research Data (http://grants.nih.gov/grants/guide/notice-files/NOT-OD-03-032.html). As of July 2018, the WF NCORP RB signed an agreement with NCI to contribute de-identified data and data dictionaries from clinical trials conducted through our RB to the NCI NCTN/NCORP data archive within 6 months of primary and non-primary publications of phase II/III and phase III trials to https://nctn-data-archive.nci.nih.gov/. This will become the primary means for sharing raw data, and we will adhere to the guidelines spelled out in the NCTN/NCORP Data Archive Usage Guide. De-identified data from studies not covered by the agreement (e.g., phase II and observational studies) will be made available upon request. All data files will be de-identified. De-identification procedures will meet the HIPAA criteria as detailed in the Code of Federal Regulations, Part 45, Section 164.514.
Study at a glance
From the registry record, last updated by the sponsor on 5 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Understanding and Enhancing Health-Related Social Needs (HRSN) Screening Among Community Oncology Practices
- ClinicalTrials.gov ID
- NCT06412029
- Acronym / sponsor ID
- HRSN / IRB00113288
- Conditions
- Cancer
- Keywords
- Cancer Health Disparities
- Study type
- Observational
- Recruitment status
- Enrolling by invitation
- Enrolment
- 144 participants (estimated)
- Lead sponsor
- Wake Forest University Health SciencesUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- 20 Nov 2024 (actual)
- Primary completion
- 30 Aug 2027 (estimated)
- Study completion
- 30 Aug 2028 (estimated)
- First posted
- 14 May 2024 (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.
This study evaluates health related social needs screening processes in community oncology clinics.
Detailed description
The primary objective of this study is to assess current processes around health related social needs (HRSN) screening among NCORP clinics and categorize clinics based on their implementation of HRSN screening. The primary endpoint will be a detailed understanding of current processes, with attention to variability by key clinic characteristics.
There are 3 parts of the study in which participants can participate in one or all parts (3 total).
Part 1: Participants attend training, complete clinic assessments and observations and may complete an interview on study.
Part 2: Identified clinic staff will be interviewed to discuss factors that influence HRSN screening at their clinic and help develop generalized guidance.
Part 3: Participants attend a co-design workshop and complete surveys on study feasibility.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Part 1 | – | Other: Non-InterventionalPart 1: Participants attend training, complete clinic assessments and observations and may complete an interview on study. |
| Part 2 | – | Other: Non-InterventionalPart 2: Identified clinic staff will be interviewed to discuss factors that influence health related social needs (HRSN) screening at their clinic and help develop generalized guidance. |
| Part 3 | – | Other: Non-InterventionalPart 3: Participants attend a co-design workshop and complete surveys on study feasibility. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- NCI Community Oncology Research Program (NCORP) clinics
Key inclusion criteria (34 listed)
- Part 1
- Must be an affiliate or sub-affiliate of an NCORP Community or Minority Underserved Community site
- Must provide outpatient oncology care
- Must be a NCORP practice (defined as one or more NCORP affiliates/sub-affiliates, that have a common administrative structure and share providers and/or patients)
- Must have identified two or more Practice Staff that are available and willing to participate on the Practice Interest Form
Key exclusion criteria (8 listed)
- Part 1
- Unable to understand, read and communicate in English, as the trainings and observations will be documented in English
- Part 3
- Unable to understand, read and communicate in English, as the workshop will be conducted in English
- Unable to understand, read and communicate in English, as the workshop will be conducted in English
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 |
|---|---|---|
| Non-InterventionalNon-interventional study | Other | Part 1, Part 2, Part 3 |
Primary outcome
HRSN screening reach (Part 1)
Time frame: From study enrollment to approximately 4 and 16 weeks post initial study training
Determining the perception of the proportion of patients at clinics who are screened for health related social needs (HRSN).
Barriers and facilitators influencing HRSN screening implementation
Time frame: From study enrollment to time completion of key informant interviews, approximately within 6 months
Synthesize themes to create a list of barriers and facilitators influencing HRSN screening implementation within high-implementation clinics, moderate-implementation clinics, and low-implementation clinics.
Generation of a tailored implementation plan for each participating clinic
Time frame: Between time of clinic selection and co-design workshop completion, to be no more than 6 months
Generation (defined for each clinic as completed or not completed) of a tailored implementation plan for each participating clinic in Part 3 that includes (1) adaptations to current HRSN screening and follow-up processes, and (2) potential implementation strategies to enhance HRSN screening implementation.
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 5 Oct 2026.
- Individual participant dataSharing planned: Yes. Wake Forest NCORP Research Base is committed to following the NIH Statement on Sharing Research Data (http://grants.nih.gov/grants/guide/notice-files/NOT-OD-03-032.html). As of July 2018, the WF NCORP RB signed an agreement with NCI to contribute de-identified data and data dictionaries from clinical trials conducted through our RB to the NCI NCTN/NCORP data archive within 6 months of primary and non-primary publications of phase II/III and phase III trials to https://nctn-data-archive.nci.nih.gov/. This will become the primary means for sharing raw data, and we will adhere to the guidelines spelled out in the NCTN/NCORP Data Archive Usage Guide. De-identified data from studies not covered by the agreement (e.g., phase II and observational studies) will be made available upon request. All data files will be de-identified. De-identification procedures will meet the HIPAA criteria as detailed in the Code of Federal Regulations, Part 45, Section 164.514.
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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.
Kathryn Weaver, PhD study chair
Wake Forest University Health Sciences
38 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cancer, run by Wake Forest University Health Sciences at 38 sites in 3 countries.
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 34 inclusion and 8 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: enrolling by invitation, as of the sponsor's last update on 5 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 38 sites in United States, Puerto Rico, Guam. 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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
HRSN screening reach (Part 1) (time frame: From study enrollment to approximately 4 and 16 weeks post initial study training). The study lists 3 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 5 Oct 2026.