NCT06412029

Brief Summary

This study evaluates health related social needs screening processes in community oncology clinics.

Trial Health

78
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
144

participants targeted

Target at P50-P75 for all trials

Timeline
6mo left

Started Nov 2024

Geographic Reach
3 countries

37 active sites

Status
enrolling by invitation

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress75%
Nov 2024Nov 2026

First Submitted

Initial submission to the registry

May 7, 2024

Completed
7 days until next milestone

First Posted

Study publicly available on registry

May 14, 2024

Completed
6 months until next milestone

Study Start

First participant enrolled

November 20, 2024

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2026

Expected
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2026

Last Updated

February 19, 2026

Status Verified

February 1, 2026

Enrollment Period

1.7 years

First QC Date

May 7, 2024

Last Update Submit

February 16, 2026

Conditions

Keywords

Cancer Health Disparities

Outcome Measures

Primary Outcomes (3)

  • HRSN screening reach (Part 1)

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

    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.

    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.

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

Study Arms (3)

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

Non-interventional study

Part 1Part 2Part 3

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

NCI Community Oncology Research Program (NCORP) clinics

You may qualify if:

  • 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:
  • 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
  • +19 more criteria

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (37)

Helen F Graham Cancer Center

Newark, Delaware, 19713, United States

Location

Carle at The Riverfront

Danville, Illinois, 61832, United States

Location

Carle Physician Group-Effingham

Effingham, Illinois, 62401, United States

Location

Carle Physician Group-Mattoon/Charleston

Mattoon, Illinois, 61938, United States

Location

Carle Cancer Institute Normal

Normal, Illinois, 61761, United States

Location

Illinois CancerCare-Peoria

Peoria, Illinois, 61615, United States

Location

Carle Cancer Center

Urbana, Illinois, 61801, United States

Location

Mission Cancer and Blood - Ankeny

Ankeny, Iowa, 50023, United States

Location

Iowa Methodist Medical Center

Des Moines, Iowa, 50309, United States

Location

Mission Cancer and Blood - Des Moines

Des Moines, Iowa, 50309, United States

Location

University Medical Center New Orleans

New Orleans, Louisiana, 70112, United States

Location

MaineHealth Cancer Care - Brunswick

Brunswick, Maine, 04011, United States

Location

Penobscot Bay Medical Center

Rockport, Maine, 04856, United States

Location

Christiana Care - Union Hospital

Elkton, Maryland, 21921, United States

Location

Cancer Hematology Centers - Flint

Flint, Michigan, 48503, United States

Location

Genesee Hematology Oncology PC

Flint, Michigan, 48503, United States

Location

Genesys Hurley Cancer Institute

Flint, Michigan, 48503, United States

Location

Essentia Health Saint Joseph's Medical Center

Brainerd, Minnesota, 56401, United States

Location

Essentia Health Cancer Center

Duluth, Minnesota, 55415, United States

Location

Hennepin County Medical Center

Minneapolis, Minnesota, 55415, United States

Location

Central Care Cancer Center - Bolivar

Bolivar, Missouri, 65613, United States

Location

CoxHealth South Hospital

Springfield, Missouri, 65807, United States

Location

NYP/Columbia University Medical Center/Herbert Irving Comprehensive Cancer Center

New York, New York, 10032, United States

Location

FirstHealth of the Carolinas-Moore Regional Hospital

Pinehurst, North Carolina, 28374, United States

Location

Wake Forest NCORP Research Base

Winston-Salem, North Carolina, 27157, United States

Location

Essentia Health Cancer Center-South University Clinic

Fargo, North Dakota, 58103, United States

Location

Geisinger Medical Center

Danville, Pennsylvania, 17822, United States

Location

Prisma Health Cancer Institute - Butternut

Greenville, South Carolina, 29605, United States

Location

Prisma Health Cancer Institute - Faris

Greenville, South Carolina, 29605, United States

Location

ThedaCare Regional Cancer Center

Appleton, Wisconsin, 54911, United States

Location

Aurora Cancer Care-Grafton

Grafton, Wisconsin, 53024, United States

Location

Aurora Cancer Care-Kenosha South

Kenosha, Wisconsin, 53142, United States

Location

Aurora Saint Luke's Medical Center

Milwaukee, Wisconsin, 53215, United States

Location

FHP Health Center-Guam

Tamuning, GU, 96913, Guam

Location

Puerto Rico Hematology Oncology Group

Bayamón, 00961, Puerto Rico

Location

Centro Comprensivo de Cancer de UPR

San Juan, 00927, Puerto Rico

Location

San Juan City Hospital

San Juan, 00936, Puerto Rico

Location

MeSH Terms

Conditions

Neoplasms

Study Officials

  • Kathryn Weaver, PhD

    Wake Forest University Health Sciences

    STUDY CHAIR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 7, 2024

First Posted

May 14, 2024

Study Start

November 20, 2024

Primary Completion (Estimated)

August 1, 2026

Study Completion (Estimated)

November 1, 2026

Last Updated

February 19, 2026

Record last verified: 2026-02

Data Sharing

IPD Sharing
Will share

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
More information

Locations