Anatomic Stage IV Breast Cancer AJCC v8NCT06206239
Evaluation of Barriers to Cancer Care Delivery and Outcomes for Women of Color With Metastatic Breast Cancer
An observational study of Anatomic Stage IV Breast Cancer AJCC v8 and Metastatic Breast Carcinoma, run by Thomas Jefferson University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Anatomic Stage IV Breast Cancer AJCC v8, Metastatic Breast Carcinoma
- How many people
- 44 participants
- Where
- 1 siteUnited States
- Study dates
- 9 Mar 2022to 31 Mar 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: Patients diagnosed with metastatic disease at Sidney Kimmel Cancer Center (SKCC)-Jefferson.
Who may be able to join
- Female
- Aged 18 and older
- English-speaking
- Diagnosed with metastatic breast cancer within 24 months of study enrollment
- Receiving treatment at the SKCC in Center City, New Jersey, or Methodist Hospital
- Provide signed and dated informed consent form
- Willing to comply with all study procedures and be available for the duration of the study
Who cannot join
- Male breast cancer patients
- Women with breast cancer that is not metastatic
- Women who discontinue treatment for their metastatic disease at SKCC
Trial locations and contacts
1 site in 1 country.
United States1 site
Thomas Jefferson University
Philadelphia, Pennsylvania, 19107
About this study
Official title: The Impact of Social Determinants of Health on Cancer Care Delivery & Outcomes for Metastatic Breast Cancer Patients
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.
Read the 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' Innovation's 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 patient's 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 patient's 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.
- Medical subject headings
- Breast Neoplasms
What is being measured
The primary outcome is the main question the study is designed to answer.
Acuity Risk Score Aim 1
For modeling the acuity risk scores, the 3-level scores will be collapsed into a binary outcome measure (low vs. medium/high) at each assessment. These longitudinal observations collected over time will be modeled by generalized logistic regression using Generalized Estimating Equations (GEE) for robust error variance accounting for the correlations in observations from the same patient. The model will include predictor terms for race, time, and race-by-time interactions. This approach will be capable of characterizing baseline racial disparities in acuity risk, as well as distinguishing which racial groups might benefit the most from the intervention of the social worker in changing acuity risk score. The coefficients for race at baseline and linear combinations of coefficients for race and time to characterize changes in acuity risk will be exponentiated for representation as odds ratios and presented with 95% confidence intervals.
Measured: 6 months
Treatment delays and interruption Aim 2
Will be represented as binary endpoints for modeling.
Measured: At end of study (3-6 months after baseline visit)
Patient adherence to recommended cancer treatment Aim 2
Will be represented as binary endpoints for modeling.
Measured: At end of study (3-6 months after baseline visit)
Patient encounter with nurse navigator, palliative care, and/or genetic counselor Aim 2
Will be represented as binary endpoints for modeling.
Measured: At end of study (3-6 months after baseline visit)
Clinical trial participation within first 24 months of metastatic breast cancer diagnosis Aim 2
Will be represented as binary endpoints for modeling
Measured: 24 months
Secondary outcomes (2)
Social determinants of health (Aim 1)
Secondary analyses will include similar models of other outcomes, including financial toxicity, social needs, barriers, and recommendations. Will explore confounding in these models, as well, by replacing the time and/or race-time interaction term(s) with socioeconomic and demographic variables. To identify the socioeconomic variables within the comprehensive screening tool that may be related to these disparities, will fit and summarize similar longitudinal GEE regression models of the respective socioeconomic component measures to identify which one(s) drive or counteract baseline racial disparities in acuity risk and/or changes in risk associated with social worker intervention.
Measured: At baseline, and repeated within 6 months
Social needs screening (Aim 1)
Via Centers for Medicare and Medicaid Services' Innovation's Accountable Health Communities Health-Related Social Needs Screening Tool Binary scale (yes/no): Living situation, Utilities, Education, Disabilities Likert Scale: Safety, Family and community support Categorical: Employment, Digital literacy
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jan 2024
- Study start9 Mar 2022
- Primary completion31 Mar 2023
- Study completion31 Mar 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Anatomic Stage IV Breast Cancer AJCC v8Studies of the same condition, open and under way.
- More trials run by Thomas Jefferson UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 44 participants (actual)
Sponsor and investigators
- Lead sponsor
- Thomas Jefferson University
- Sponsor type
- University, hospital or other
- Collaborators
- Pfizer
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06206239
- Sponsor's protocol ID
- 22G.119
- Other IDs
- JT 20526
- Status last verified
- May 2025
- First submitted
- 2 Mar 2023
- Last updated
- 20 May 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Impact of Social Determinants of Health on Cancer Care Delivery & Outcomes for Metastatic Breast Cancer Patients
- ClinicalTrials.gov ID
- NCT06206239
- Acronym / sponsor ID
- 22G.119
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 44 participants (actual)
- Lead sponsor
- Thomas Jefferson UniversityUniversity, hospital or other
- Collaborators
- Pfizer
- Study start
- 9 Mar 2022 (actual)
- Primary completion
- 31 Mar 2023 (actual)
- Study completion
- 31 Mar 2024 (actual)
- First posted
- 16 Jan 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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' Innovation's 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 patient's 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 patient's 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 design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients diagnosed with metastatic disease at Sidney Kimmel Cancer Center (SKCC)-Jefferson.
Key inclusion criteria (7 listed)
- Female
- Aged 18 and older
- English-speaking
- Diagnosed with metastatic breast cancer within 24 months of study enrollment
- Receiving treatment at the SKCC in Center City, New Jersey, or Methodist Hospital
Key exclusion criteria (3 listed)
- Male breast cancer patients
- Women with breast cancer that is not metastatic
- Women who discontinue treatment for their metastatic disease at SKCC
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Acuity Risk Score Aim 1
Time frame: 6 months
For modeling the acuity risk scores, the 3-level scores will be collapsed into a binary outcome measure (low vs. medium/high) at each assessment. These longitudinal observations collected over time will be modeled by generalized logistic regression using Generalized Estimating Equations (GEE) for robust error variance accounting for the correlations in observations from the same patient. The model will include predictor terms for race, time, and race-by-time interactions. This approach will be capable of characterizing baseline racial disparities in acuity risk, as well as distinguishing which racial groups might benefit the most from the intervention of the social worker in changing acuity risk score. The coefficients for race at baseline and linear combinations of coefficients for race and time to characterize changes in acuity risk will be exponentiated for representation as odds ratios and presented with 95% confidence intervals.
Treatment delays and interruption Aim 2
Time frame: At end of study (3-6 months after baseline visit)
Will be represented as binary endpoints for modeling.
Patient adherence to recommended cancer treatment Aim 2
Time frame: At end of study (3-6 months after baseline visit)
Will be represented as binary endpoints for modeling.
Patient encounter with nurse navigator, palliative care, and/or genetic counselor Aim 2
Time frame: At end of study (3-6 months after baseline visit)
Will be represented as binary endpoints for modeling.
Clinical trial participation within first 24 months of metastatic breast cancer diagnosis Aim 2
Time frame: 24 months
Will be represented as binary endpoints for modeling
2 secondary outcomes
Social determinants of health (Aim 1)
Time frame: At baseline, and repeated within 6 months
Social needs screening (Aim 1)
Time frame: 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 May 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Anatomic Stage IV Breast Cancer AJCC v8 and Metastatic Breast Carcinoma, run by Thomas Jefferson University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Acuity Risk Score Aim 1 (time frame: 6 months). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 May 2025; AzTrials last refreshed its copy on 8 Nov 2026.