Ignite Creation Date:
2024-05-06 @ 7:57 PM
Last Modification Date:
2024-10-26 @ 3:18 PM
Study NCT ID:
NCT06206239
Status:
COMPLETED
Last Update Posted:
2024-05-16
First Post:
2023-03-02
Brief Title:
Evaluation of Barriers to Cancer Care Delivery and Outcomes for Women of Color With Metastatic Breast Cancer
Sponsor:
Thomas Jefferson University
Organization:
Thomas Jefferson University
Study Overview
Official Title:
The Impact of Social Determinants of Health on Cancer Care Delivery Outcomes for Metastatic Breast Cancer Patients
Status:
COMPLETED
Status Verified Date:
2024-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This study evaluates disparities and barriers in cancer care delivery and outcomes in women of color by identifying socioeconomic variables that may be related to the inequity Social determinants of health or the conditions in which people live work and play have a profound effect on health outcomes This research is being done to understand whether social determinants of health factors like employment household income and home ownership affect access to care services and outcomes for patients with metastatic breast cancer who receive their cancer treatment at Sidney Kimmel Cancer Center at Jefferson Health
Detailed Description:
This is a single arm study that seeks to identify disparities in delivery of care and treatment outcomes for metastatic breast cancer patients of color and to identify socioeconomic variables that may be related to the inequity The study will enroll female patients ages 18 years initially diagnosed with metastatic disease within 60 months of study enrollment and continue to receive treatment for their metastatic disease at SKCC-Jefferson
Patients will have an in person or telehealth encounter with an oncology social worker at baseline and when feasible one additional encounter at 3-6 months from baseline At each encounter a comprehensive screening tool will be completed by the oncology social work that includes 3 instruments SDOH wheel CMS Innovations Accountable Health Communities Health-Related Social Needs Screening Tool 16 and Oncology Support tab All three instruments will be administered by a social worker at the patients first encounter following consent to participate in the study and when feasible re-administered at the next visit An acuity risk score will be calculated within the EMR for each of the encounters based on data input into the SDOH section
The social worker will also record information about financial toxicity social needs barriers to medical care and recommended intervention We will supplement the data extracted from our EMR with data extracted or calculated from county- or state-level data files to add to our ability to predict SDOH variables that are most associated with cancer care delivery or health outcomes This includes calculating an Area Deprivation Index for each patient which is a reflection of the level of neighborhood deprivation where a patient lives 15 We will also calculate the distance to travel to the cancer center for each patient based on their current address County-level breast cancer incidence and mortality will be added for each patient based on their current county of residence as these rates are proxies for access to cancer care among residents of a particular county Lastly we will add county-level rates of employment home ownership and educational attainment as measurements of SDOH that may influence outcomes among metastatic breast cancer patients
We will complete a retrospective chart review to identify patients who had delays in starting their recommended first line systemic treatment of greater than 21 days from their initial metastatic breast cancer diagnosis and collect information on the reason for the treatment delay when available We will also measure the number of treatment interruptions of greater than 7 days during the course of a patients first 3 lines of systemic treatment and categorize these interruptions as due to side effects vs reasons other than side effects We will also measure any interruption in their palliative radiation therapy and categorize these interruptions as due to side effect vs other reasons We plan to evaluate the number of referrals that are placed by the social worker or the provider at time of the comprehensive screening assessment and tracking if the patient had an appointment with Palliative Care genetic counseling and Psychiatry Oncology within 3 months of the referral placed by a cancer care providers or oncology social worker We will also evaluate the effect of the mentioned SES and SDOH measures on clinical trial participation of metastatic breast cancer
The study will last approximately 12 months
Patients will have an in person or telehealth encounter with an oncology social worker at baseline and when feasible one additional encounter at 3-6 months from baseline At each encounter a comprehensive screening tool will be completed by the oncology social work that includes 3 instruments SDOH wheel CMS Innovations Accountable Health Communities Health-Related Social Needs Screening Tool 16 and Oncology Support tab All three instruments will be administered by a social worker at the patients first encounter following consent to participate in the study and when feasible re-administered at the next visit An acuity risk score will be calculated within the EMR for each of the encounters based on data input into the SDOH section
The social worker will also record information about financial toxicity social needs barriers to medical care and recommended intervention We will supplement the data extracted from our EMR with data extracted or calculated from county- or state-level data files to add to our ability to predict SDOH variables that are most associated with cancer care delivery or health outcomes This includes calculating an Area Deprivation Index for each patient which is a reflection of the level of neighborhood deprivation where a patient lives 15 We will also calculate the distance to travel to the cancer center for each patient based on their current address County-level breast cancer incidence and mortality will be added for each patient based on their current county of residence as these rates are proxies for access to cancer care among residents of a particular county Lastly we will add county-level rates of employment home ownership and educational attainment as measurements of SDOH that may influence outcomes among metastatic breast cancer patients
We will complete a retrospective chart review to identify patients who had delays in starting their recommended first line systemic treatment of greater than 21 days from their initial metastatic breast cancer diagnosis and collect information on the reason for the treatment delay when available We will also measure the number of treatment interruptions of greater than 7 days during the course of a patients first 3 lines of systemic treatment and categorize these interruptions as due to side effects vs reasons other than side effects We will also measure any interruption in their palliative radiation therapy and categorize these interruptions as due to side effect vs other reasons We plan to evaluate the number of referrals that are placed by the social worker or the provider at time of the comprehensive screening assessment and tracking if the patient had an appointment with Palliative Care genetic counseling and Psychiatry Oncology within 3 months of the referral placed by a cancer care providers or oncology social worker We will also evaluate the effect of the mentioned SES and SDOH measures on clinical trial participation of metastatic breast cancer
The study will last approximately 12 months
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None