Breast Cancer Clinical Trial
— Breast_SBDOHOfficial title:
Early Point-of-Service SBDOH Screening in Breast Cancer
NCT number | NCT06019988 |
Other study ID # | 19122 |
Secondary ID | |
Status | Recruiting |
Phase | N/A |
First received | |
Last updated | |
Start date | March 11, 2024 |
Est. completion date | March 11, 2025 |
The overarching goal of this project is to optimize the collection of social and behavioral determinants of health (SBDOH) for patients with a pathological diagnosis of breast cancer at Penn Medicine. The investigators will measure rates of SBDOH data collection by modality and rates of referral to and uptake of social support services, time to evaluation, staff time, acceptability, patient-centered communication, medical mistrust, and clinician acceptability.
Status | Recruiting |
Enrollment | 2500 |
Est. completion date | March 11, 2025 |
Est. primary completion date | March 11, 2025 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: Based on available EHR data, patients will be eligible for Activities 1 and 2 if they: - Are referred to one of the following locations for surgical consult following a new diagnosis of operable (Stage 0-III) breast cancer: the Hospital of the University of Pennsylvania (HUP), Penn Presbyterian Medical Center (PPMC), Pennsylvania Hospital (PAH), and Penn Medicine Radnor - Are female - Are 18 years of age or older, and - Are able to read and speak English or Spanish Clinicians and clinical leaders will be eligible for participation in Activity 2 if they: - Presently work as a clinician or clinical leader in breast surgery or oncology - Access PennChart as an aspect of their clinical duties - Are 18 years of age or older - Are able to read and speak English or Spanish Exclusion Criteria: Based on available EHR data, patients will be ineligible if they: - Are listed as not wanting to be contacted or solicited for research; - Have known metastatic disease at time of enrollment; and/or - Do not otherwise meet all of the enrollment criteria Clinicians and clinical leaders will be ineligible for participation in Activity 2 if they: - Are not presently engaged in clinical duties or - Do not otherwise meet all of the enrollment criteria This study will not exclude men or nonbinary people who may be diagnosed with breast cancer, but investigators anticipate the sample size for these characteristics will be too small to support meaningful analysis. |
Country | Name | City | State |
---|---|---|---|
United States | University of Pennsylvania | Philadelphia | Pennsylvania |
Lead Sponsor | Collaborator |
---|---|
Abramson Cancer Center at Penn Medicine | Gilead Sciences |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Rates of SBDOH screen completion prior to initial surgical consult | Rates of SBDOH screen completion prior to initial surgical consult will be first compared by instrument (Accountable Health Communities Health-Related Social Needs Screening Tool [AHC-HRSN], Health Leads Social Needs Screening Toolkit [Health Leads], National Comprehensive Cancer Network Distress Thermometer and Problem List [NCCN DT + PL]). Only the NCCN DT employs a 10-point Likert scale, where 0 = no distress and 10 = extreme distress. Among patients who do not respond to initial screening administration and who then receive the screening via either chatbot or IVR, rates of SBDOH screen completion will be compared by modality. | 1 year | |
Secondary | Time from biopsy to initial surgical consult | Time to evaluation (TTE) will be compared first by instrument (Accountable Health Communities Health-Related Social Needs Screening Tool [AHC-HRSN], Health Leads Social Needs Screening Toolkit [Health Leads], National Comprehensive Cancer Network Distress Thermometer and Problem List [NCCN DT + PL]). Only the NCCN DT employs a 10-point Likert scale, where 0 = no distress and 10 = extreme distress. Among patients who do not respond to initial screening administration and who then receive the screening via either chatbot or IVR, rates of SBDOH screen completion will be compared by modality. | 1 years | |
Secondary | Identify factors associated with rates of post-diagnosis, pre-consultation SBDOH screen completion | Factors associated with rates of SBDOH screen completion across all instruments (AHC-HRSN, Health Leads, and NCCN DT + PL) and modalities will be assessed via individual semi-structured qualitative interviews with patients who participate in Activity 1 as well as clinicians or clinical leaders. | 6 months |
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