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Enrolling by Invitation

NCT Number: NCT06412029

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

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

Enrolling by Invitation

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Key information

Conditions

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

FHP Health Center-Guam, Tamuning, GU, Guam

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About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Non-Interventional

Other

Non-interventional study

Primary outcomes

  1. HRSN screening reach (Part 1)

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

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

  2. Barriers and facilitators influencing HRSN screening implementation

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

    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.

  3. Generation of a tailored implementation plan for each participating clinic

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

    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.

Sponsors and collaborators

Lead sponsor

Wake Forest University Health Sciences

Other

Collaborators

  • National Cancer Institute (NCI)

Registry information

Acronym: HRSN

Important dates

Study start
2024
Primary completion
2027
Study completion
2028
First posted
May 14, 2024
Registry last updated
Jul 24, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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