- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03881085
Stress Reactivity Among African American Breast Cancer Survivors
January 29, 2026 updated by: Medical University of South Carolina
The Science of Behavior Change in African American Breast Cancer Survivors
Despite increased access to early detection and the availability of more effective therapeutic strategies, African American women continue to experience excess rates of morbidity and mortality from breast cancer.
An emerging hypothesis about breast cancer disparities is that social conditions and physiological responses to social stressors influence biological processes that are important to the initiation and progression of disease.
This hypothesis is based on data from animal studies which have shown that rats that are exposed to social stressors such as isolation are likely to develop mammary tumors that are histologically and etiologically similar to those that develop among African American women.
The HPA axis plays a central role in regulating the physiological stress response; dysregulation of the HPA has been suggested as a mechanism through which social and biological factors contribute to racial disparities in breast cancer outcomes.
Many African Americans experience stressful life events and circumstances, including economic, discriminatory, and other stressors.
These social factors may contribute to an increased risk of advanced stage disease, but not all African American women who are exposed to adverse social factors develop advanced stage disease and those who have a limited number of psychosocial stressors can develop advanced stage breast cancer, regardless of early detection.
This may be because stress reactivity, or one's physiological and psychological responses to a stressor, is highly individualized and dependent on psychological and social determinants as well as genetic factors.
But, these biological and psychosocial pathways have not been examined among women at increased risk for disparities.
Therefore, this study will characterize stress reactivity and emotional regulation among African American breast cancer survivors and measure the association between these responses and decisions about cancer control and treatment compliance.
As part of providing empirical data on biological and psychological pathways that contribute to breast cancer disparities, the investigator's study will identify novel intervention targets that can be used to improve self-management in a population that is at risk for limited cancer control.
Study Overview
Status
Completed
Conditions
Detailed Description
Dysregulation of the HPA has been suggested as a mechanism through which social and biological factors contribute to racial disparities in breast cancer outcomes.The HPA axis plays a central role in regulating the physiological stress response;a prolonged and elevated glucocorticoid (GC) response following a social stressor predicts tumor growth rates and the development of mammary cancer in rats that histologically and etiologically resembles human disease.Many African Americans experience stressful life events and circumstances, including economic, discriminatory, and other stressors.
These psychosocial factors may contribute to an increased risk of advanced stage breast cancer among African American women, but not all African American women who are exposed to adverse psychosocial and social stressors develop advanced stage breast cancer and African American women who have a limited number of stressors also develop advanced stage breast cancer, regardless of early detection.
This may be because stress reactivity, or one's physiological and psychological responses to a stressor, is highly individualized and dependent on psychological and social determinants.
However, empirical data are not available on stress reactivity among African American breast cancer survivors and how these reactions vary among women based on their exposure to chronic stressors and psychological characteristics.
Empirical data are also lacking on the association between stress reactivity and cancer control behaviors among African American breast cancer survivors even though prior studies have shown that these women are less likely than whites to engage in health behaviors that are important to cancer control and research is now being conducted to understand how stress affects these behaviors.This research is testing the hypothesis that stress: (1) promotes temporal discounting; (2) has an adverse effect on self-efficacy, and (3) reduces executive functioning (e.g., goal setting, planning).
However, stress reactivity, and the association between these responses and cancer control behaviors (e.g., diet, physical activity, and treatment compliance), have not been examined among African American breast cancer survivors.
Prior studies have shown that African Americans have a dysregulated stress response as a result of persistent exposure to chronic and acute and stressors; this may alter stress responses and lead to high levels of allostatic load.
In order to develop effective behavioral interventions for African American breast cancer survivors, an important first step is to verify that the mechanisms (e.g., temporal discounting, self-efficacy) involved in health behaviors for cancer control (e.g., diet, physical activity, treatment compliance) are associated with stress reactivity among these women.
Therefore this study will characterize stress reactivity among African American breast cancer survivors and validate the association between these responses and targeted mechanisms of behavior change.
Study Type
Observational
Enrollment (Actual)
110
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
South Carolina
-
Charleston, South Carolina, United States, 29425
- Medical University of South Carolina
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
21 years to 75 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Sampling Method
Non-Probability Sample
Study Population
Subjects eligible to participate in this study include African American breast cancer survivors who were diagnosed with Stage I, II, or Illa disease and have completed all breast cancer treatment.
Women who are both acute and long-term survivors are eligible to participate in this study.
For all women, patients must have been between the ages of 21-75 at diagnosis and diagnosed within the last 5 years.
For those who are acute survivors, patients are eligible to participate in the study if they completed surgical treatment within the past three months, regardless of if they have initiated adjuvant therapy.
Description
Inclusion Criteria:
- Self-identify as African American or Black women
- Histologically confirmed stage of I, II, or IIIa breast cancer.
- Between the ages of 21-75 at diagnosis
- Have been diagnosed within the last 5 years
Exclusion Criteria:
- Women who are not African American or Black
- Diagnosed with a later stage of breast cancer
- Not within the defined treatment parameters
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Examine stress reactivity among African American Breast Cancer Survivors utilizing cortisol.
Time Frame: 21 months
|
Conduct an A Tier Social Stress Test (TSST)with patients to induce a stress response.
Cortisol is being examined as a stress biomarker and will be measured at baseline, at multiple timepoints (n=3) during the TSST, and immediately after the TSST to assess changes in cortisol levels.
|
21 months
|
|
Examine stress reactivity among African American Breast Cancer Survivors utilizing vital signs.
Time Frame: 21 months
|
Collect vital assessments that include heart rate and systolic and diastolic blood pressure at baseline, during the course of the Trier Social Stress Test (TSST), and immediately after the TSST in order to examine changes in vitals as it relates to stress responses during the TSST.
|
21 months
|
|
Examine the association between levels of stress reactivity and stressors as it relates to socioeconomic status, clinical factors, and social stress
Time Frame: 21 months
|
Characterize the nature and distribution of stress reactivity among African American breast cancer survivors based on socioeconomic, clinical, and social stressors.
Socioeconomic status will be collected via self-report utilizing household income and education items from the Behavioral Risk Factor Surveillance System (BRFSS) tool.
Financial strain will be evaluated using the Comprehensive Score for financial Toxicity (COST) tool.
Social stress will be assessed by levels of social isolation using the loneliness scale.
Clinical variables relating to disease stage will be extracted from the patient's electronic medical record.
|
21 months
|
|
Examine glucocorticoid sensitivity as a potential predictor of stress reactivity
Time Frame: 21 months
|
A blood sample will determine circulating levels of neutrophils, lymphocytes, and monocytes to determine glucocorticoid sensitivity.
|
21 months
|
|
Examine stress reactivity on temporal discounting
Time Frame: 21 months
|
The Kirby Delay Discounting Task conducted immediately (10 minutes) or longer (20 minutes) following exposure to the Trier Social Stress Test to examine temporal discounting.
|
21 months
|
|
Determine the extent to which active engagement with a stressor is associated with adherence to dietary recommendations for cancer control
Time Frame: 1 month
|
Self-reported diet behaviors will be associated with levels of stress reactivity 1-month following stress induction.
|
1 month
|
|
Determine the extent to which active engagement with a stressor is associated with adherence to physical activity recommendations for cancer control
Time Frame: 1 month
|
Self-reported physical activity behaviors will be associated with levels of stress reactivity 1-month following stress induction.
|
1 month
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
October 19, 2018
Primary Completion (Actual)
July 20, 2021
Study Completion (Actual)
July 20, 2021
Study Registration Dates
First Submitted
March 4, 2019
First Submitted That Met QC Criteria
March 15, 2019
First Posted (Actual)
March 19, 2019
Study Record Updates
Last Update Posted (Actual)
February 2, 2026
Last Update Submitted That Met QC Criteria
January 29, 2026
Last Verified
January 1, 2026
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- AABCSR
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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