Understanding and Enhancing Health-Related Social Needs (HRSN) Screening Among Community Oncology Practices
NCT ID: NCT06412029
Last Updated: 2025-11-06
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
ENROLLING_BY_INVITATION
144 participants
OBSERVATIONAL
2024-10-31
2026-11-30
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
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
See the medical conditions and disease areas that this research is targeting or investigating.
Keywords
Explore important study keywords that can help with search, categorization, and topic discovery.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
COHORT
PROSPECTIVE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Part 1
Part 1: Participants attend training, complete clinic assessments and observations and may complete an interview on study.
Non-Interventional
Non-interventional study
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.
Non-Interventional
Non-interventional study
Part 3
Part 3: Participants attend a co-design workshop and complete surveys on study feasibility.
Non-Interventional
Non-interventional study
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Non-Interventional
Non-interventional study
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
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
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
18 Years
ALL
Yes
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
National Cancer Institute (NCI)
NIH
Wake Forest University Health Sciences
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Kathryn Weaver, PhD
Role: STUDY_CHAIR
Wake Forest University Health Sciences
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Helen F Graham Cancer Center
Newark, Delaware, United States
Carle at The Riverfront
Danville, Illinois, United States
Carle Physician Group-Effingham
Effingham, Illinois, United States
Carle Physician Group-Mattoon/Charleston
Mattoon, Illinois, United States
Carle Cancer Institute Normal
Normal, Illinois, United States
Illinois CancerCare-Peoria
Peoria, Illinois, United States
Carle Cancer Center
Urbana, Illinois, United States
Mission Cancer and Blood - Ankeny
Ankeny, Iowa, United States
Iowa Methodist Medical Center
Des Moines, Iowa, United States
Mission Cancer and Blood - Des Moines
Des Moines, Iowa, United States
University Medical Center New Orleans
New Orleans, Louisiana, United States
MaineHealth Cancer Care - Brunswick
Brunswick, Maine, United States
Penobscot Bay Medical Center
Rockport, Maine, United States
Christiana Care - Union Hospital
Elkton, Maryland, United States
Cancer Hematology Centers - Flint
Flint, Michigan, United States
Genesee Hematology Oncology PC
Flint, Michigan, United States
Genesys Hurley Cancer Institute
Flint, Michigan, United States
Essentia Health Saint Joseph's Medical Center
Brainerd, Minnesota, United States
Essentia Health Cancer Center
Duluth, Minnesota, United States
Hennepin County Medical Center
Minneapolis, Minnesota, United States
Central Care Cancer Center - Bolivar
Bolivar, Missouri, United States
CoxHealth South Hospital
Springfield, Missouri, United States
NYP/Columbia University Medical Center/Herbert Irving Comprehensive Cancer Center
New York, New York, United States
FirstHealth of the Carolinas-Moore Regional Hospital
Pinehurst, North Carolina, United States
Wake Forest NCORP Research Base
Winston-Salem, North Carolina, United States
Essentia Health Cancer Center-South University Clinic
Fargo, North Dakota, United States
Geisinger Medical Center
Danville, Pennsylvania, United States
Prisma Health Cancer Institute - Butternut
Greenville, South Carolina, United States
Prisma Health Cancer Institute - Faris
Greenville, South Carolina, United States
ThedaCare Regional Cancer Center
Appleton, Wisconsin, United States
Aurora Cancer Care-Grafton
Grafton, Wisconsin, United States
Aurora Cancer Care-Kenosha South
Kenosha, Wisconsin, United States
Aurora Saint Luke's Medical Center
Milwaukee, Wisconsin, United States
FHP Health Center-Guam
Tamuning, GU, Guam
Puerto Rico Hematology Oncology Group
Bayamón, , Puerto Rico
Centro Comprensivo de Cancer de UPR
San Juan, , Puerto Rico
San Juan City Hospital
San Juan, , Puerto Rico
Countries
Review the countries where the study has at least one active or historical site.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
NCI-2024-02411
Identifier Type: OTHER
Identifier Source: secondary_id
WF-2303CD
Identifier Type: OTHER
Identifier Source: secondary_id
IRB00113288
Identifier Type: -
Identifier Source: org_study_id