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Enrolling by invitationNCT06412029HRSNUpdated Oct 5, 2026

Understanding and Enhancing Health-Related Social Needs (HRSN) Screening Among Community Oncology Practices

An observational study in Cancer, sponsored by Wake Forest University Health Sciences. Enrolling by invitation at 38 sites in 3 countries. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-10-05.

Sponsored by Wake Forest University Health Sciences · Observational

Updated Oct 5, 20261 site addedGo to Updates ↓
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
144
Ages
18 Years and older
Sex
All
01

Study summary

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.

02

Conditions studied

  • Cancer

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Keywords

  • Cancer Health Disparities
03

In context

Neoplasms

10,818 studies on the registry are indexed under Neoplasms; 2,324 are open to participants now.

This study's planned enrollment of 144 is below the median of 200 across 2,638 observational studies indexed under Neoplasms.

Browse Neoplasms studies →

Lead sponsor

Wake Forest University Health Sciences is the lead sponsor of 1,351 studies on the registry; 201 are open to participants now.

Of its 332 completed or terminated interventional studies of FDA-regulated products, 251 (76%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
Yes
Sampling method
Non-probability sample

Study population

NCI Community Oncology Research Program (NCORP) clinics

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

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
  • 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.

Exclusion criteria

Exclusion Criteria:

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

05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
144 participants (estimated)
Patient registry
No

Groups and cohorts

  • Part 1

    Part 1: Participants attend training, complete clinic assessments and observations and may complete an interview on study.

    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.

    Other: Non-Interventional

  • Part 3

    Part 3: Participants attend a co-design workshop and complete surveys on study feasibility.

    Other: Non-Interventional

Interventions

  • OtherNon-Interventional

    Non-interventional study

06

What researchers measure

Primary outcomes

  1. HRSN screening reach (Part 1)

    Determining the perception of the proportion of patients at clinics who are screened for health related social needs (HRSN).

    Time frame: From study enrollment to approximately 4 and 16 weeks post initial study training

  2. 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.

    Time frame: From study enrollment to time completion of key informant interviews, approximately within 6 months

  3. 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.

    Time frame: Between time of clinic selection and co-design workshop completion, to be no more than 6 months

07

Study locations

38 sites
08

References and documents

Individual participant data

Plan to share: 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.

Time frame: 6 months after publication for a 2 year duration

Access criteria: upon request to NCORP@wakehealth.edu

Data sharing details ↗ · nctn-data-archive.nci.nih.gov

No publications or documents are linked to this record.

09

Timeline

1 registry update since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Started Nov 2024 (actual). Primary completion is estimated for Aug 2027, 33 months after the start.

Of 1,098 non-industry observational studies under Neoplasms, half reached primary completion within 61 months of starting (the median), counting those still running; a quarter within 24 and three quarters within 227. This study's planned 33 months is below that.

Counting every sponsor, half of 1,246 studies reached it within 58 months; a quarter within 24 and three quarters within 210.

Neoplasms covers many different conditions, not one, so the studies compared here vary widely. Read these figures as a rough guide.

How these figures are worked out, and which studies are left out of them.

Registered
May 7, 2024
First posted
May 14, 2024
StartActual
Nov 20, 2024
Primary completionEst.
Aug 30, 2027
CompletionEst.
Aug 30, 2028
Last update
Oct 5, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
Sites
1 site added
Show site
  • Mercy Medical Center - Des Moines · Des Moines, United States
Oct 5, 2026
Show all 1 update
  1. Oct 5, 2026
    1 site added
    Show site
    • Mercy Medical Center - Des Moines · Des Moines, United States
    + 1 other change: verification date

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

10

Registry details

Key details

Study ID
NCT06412029
Responsible party
Sponsor
First posted
May 14, 2024
Start date
Nov 20, 2024
Primary completion
Aug 30, 2027 (estimated)
Completion
Aug 30, 2028 (estimated)
Last update
Oct 5, 2026

Study contacts

Kathryn Weaver, PhD
study chair · Wake Forest University Health Sciences

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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