Early Point-of-Service Social and Behavioral Determinants of Health (SBDOH) Screening and Enhance… (NCT06019988) | Clinical Trial Compass
Active — Not RecruitingNot Applicable
Early Point-of-Service Social and Behavioral Determinants of Health (SBDOH) Screening and Enhanced Navigation on Care Delivery for Patients With Breast Cancer
United States2,500 participantsStarted 2024-03-11
Plain-language summary
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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1This trial focuses on screening for social and behavioral factors — things like transportation, housing, or financial stress — before a first surgical appointment for breast cancer. Can you help me understand how those kinds of factors might actually affect my care, and whether getting screened for them early would be useful in my situation?
2Since this trial is 'active but not recruiting,' I can't join it anymore — but does our clinic or hospital already do any kind of social needs screening before surgical consultations, and if so, how would that work for me?
3The trial is measuring how often patients complete this type of screening before seeing a surgeon. What happens if social or financial barriers are identified — what support or navigation resources would actually be available to me?
4Given that this is categorized as a non-phase study focused on care delivery rather than a new drug or treatment, does participating in something like this carry any risks I should know about, or would it mainly change how I'm connected to support services?
5My priority right now is getting my breast cancer treatment started quickly — would taking part in a social needs screening process like the one in this trial slow down or change the timing of my surgical consultation in any way?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Rates of SBDOH screen completion prior to initial surgical consult