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

Cancer Clinical Trial

— HRSN  

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06412029
• Other study ID #: WF-2303CD
• Secondary ID: NCI-2024-02411WF
• Status: Not yet recruiting
• Start date: August 2024
• Est. completion date: November 2026

Study information

• Verified date: May 2024
• Source: Wake Forest University Health Sciences
• Contact: Karen Craver
• Phone: 336-716-0891
• Email: NCORP[@]wakehealth.edu
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 144
• Est. completion date: November 2026
• Est. primary completion date: August 2026
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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 semistructured interview (approximately 30 minutes; in-person or remotely over the internet or by phone)

• 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 interviews and the workshop.

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

Related Conditions & MeSH terms

• Cancer

Intervention

Other:
• Non-Interventional
Non-interventional study

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Wake Forest University Health Sciences	National Cancer Institute (NCI)

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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