Clinical trial NCT06412029: Understanding and Enhancing Health-Related Social Needs (HRSN) Screening Among Community Oncology Practices
Official title: Understanding and Enhancing Health-Related Social Needs (HRSN) Screening Among Community Oncology Practices
Study type: OBSERVATIONAL
Overall status: ENROLLING_BY_INVITATION
Conditions: Cancer
Keywords: Cancer Health Disparities
Lead sponsor: Wake Forest University Health Sciences
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2024-05-14
Enrollment: 144
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: NCI Community Oncology Research Program (NCORP) clinics

Brief summary: 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.

Eligibility criteria: 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:

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

Primary outcomes:
measure: HRSN screening reach (Part 1)
timeFrame: From study enrollment to approximately 4 and 16 weeks post initial study training
measure: Barriers and facilitators influencing HRSN screening implementation
timeFrame: From study enrollment to time completion of key informant interviews, approximately within 6 months
measure: Generation of a tailored implementation plan for each participating clinic
timeFrame: Between time of clinic selection and co-design workshop completion, to be no more than 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Newark
country: United States
facility: Helen F Graham Cancer Center
state: Delaware
city: Danville
country: United States
facility: Carle at The Riverfront
state: Illinois
city: Effingham
country: United States
facility: Carle Physician Group-Effingham
state: Illinois
city: Mattoon
country: United States
facility: Carle Physician Group-Mattoon/Charleston
state: Illinois
city: Normal
country: United States
facility: Carle Cancer Institute Normal
state: Illinois
city: Peoria
country: United States
facility: Illinois CancerCare-Peoria
state: Illinois
city: Urbana
country: United States
facility: Carle Cancer Center
state: Illinois
city: Ankeny
country: United States
facility: Mission Cancer and Blood - Ankeny
state: Iowa
city: Des Moines
country: United States
facility: Iowa Methodist Medical Center
state: Iowa
city: Des Moines
country: United States
facility: Mission Cancer and Blood - Des Moines
state: Iowa
city: New Orleans
country: United States
facility: University Medical Center New Orleans
state: Louisiana
city: Brunswick
country: United States
facility: MaineHealth Cancer Care - Brunswick
state: Maine
city: Rockport
country: United States
facility: Penobscot Bay Medical Center
state: Maine
city: Elkton
country: United States
facility: Christiana Care - Union Hospital
state: Maryland
city: Flint
country: United States
facility: Cancer Hematology Centers - Flint
state: Michigan
city: Flint
country: United States
facility: Genesee Hematology Oncology PC
state: Michigan
city: Flint
country: United States
facility: Genesys Hurley Cancer Institute
state: Michigan
city: Brainerd
country: United States
facility: Essentia Health Saint Joseph's Medical Center
state: Minnesota
city: Duluth
country: United States
facility: Essentia Health Cancer Center
state: Minnesota
city: Minneapolis
country: United States
facility: Hennepin County Medical Center
state: Minnesota
city: Bolivar
country: United States
facility: Central Care Cancer Center - Bolivar
state: Missouri
city: Springfield
country: United States
facility: CoxHealth South Hospital
state: Missouri
city: Pinehurst
country: United States
facility: FirstHealth of the Carolinas-Moore Regional Hospital
state: North Carolina
city: Winston-Salem
country: United States
facility: Wake Forest NCORP Research Base
state: North Carolina
city: Fargo
country: United States
facility: Essentia Health Cancer Center-South University Clinic
state: North Dakota
city: Danville
country: United States
facility: Geisinger Medical Center
state: Pennsylvania
city: Greenville
country: United States
facility: Prisma Health Cancer Institute - Butternut
state: South Carolina
city: Greenville
country: United States
facility: Prisma Health Cancer Institute - Faris
state: South Carolina
city: Appleton
country: United States
facility: ThedaCare Regional Cancer Center
state: Wisconsin
city: Grafton
country: United States
facility: Aurora Cancer Care-Grafton
state: Wisconsin
city: Kenosha
country: United States
facility: Aurora Cancer Care-Kenosha South
state: Wisconsin
city: Milwaukee
country: United States
facility: Aurora Saint Luke's Medical Center
state: Wisconsin
city: Tamuning
country: Guam
facility: FHP Health Center-Guam
city: Bayamon
country: Puerto Rico
facility: Puerto Rico Hematology Oncology Group
city: San Juan
country: Puerto Rico
facility: Centro Comprensivo de Cancer de UPR
city: San Juan
country: Puerto Rico
facility: San Juan City Hospital
Study officials:
affiliation: Wake Forest University Health Sciences
name: Kathryn Weaver, PhD
role: STUDY_CHAIR
References: