Evaluation of Barriers to Cancer Care Delivery and Outcomes for Women of Color With Metastatic Breast Cancer

NCT06206239 | Completed

• 2 other identifiers: 22G.119JT 20526
• Study Type: observational
• Target: 44
• Locations: 1 country
• Sites: 1

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.

Conditions

Anatomic Stage IV Breast Cancer AJCC v8; Metastatic Breast Carcinoma

Outcome Measures

Primary Outcomes (5)

• 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.

  6 months

• Treatment delays and interruption Aim 2

  Will be represented as binary endpoints for modeling.

  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.

  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.

  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

  24 months

Secondary Outcomes (2)

• Social determinants of health (Aim 1)

  At baseline, and repeated within 6 months

• Social needs screening (Aim 1)

  6 months

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients diagnosed with metastatic disease at Sidney Kimmel Cancer Center (SKCC)-Jefferson.

You may qualify if:

• 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

You may not qualify if:

• Male breast cancer patients
• Women with breast cancer that is not metastatic
• Women who discontinue treatment for their metastatic disease at SKCC

Sponsors & Collaborators

• Thomas Jefferson University: lead
• Pfizer: collaborator

Study Sites (1)

Thomas Jefferson University

Philadelphia, Pennsylvania, 19107, United States

Location

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 2, 2023
• First Posted: January 16, 2024
• Study Start: March 9, 2022
• Primary Completion: March 31, 2023
• Study Completion: March 31, 2024
• Last Updated: May 20, 2025

Record last verified: 2025-05

Locations

US (1)