Breast Cancer FemaleNCT03881085
Stress Reactivity Among African American Breast Cancer Survivors
An observational study of Breast Cancer Female and Stress Reaction, run by Medical University of South Carolina at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 21 to 75 years, women only
- Conditions the study is for
- Breast Cancer Female, Stress Reaction
- How many people
- 110 participants
- Where
- 1 siteUnited States
- Study dates
- 19 Oct 2018to 20 Jul 2021
- 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 21 to 75 years
- Women only
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- Women who are not African American or Black
- Diagnosed with a later stage of breast cancer
- Not within the defined treatment parameters
Trial locations and contacts
1 site in 1 country.
United States1 site
Medical University of South Carolina
Charleston, South Carolina, 29425
About this study
Official title: 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.
Read the 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.
- Conditions
- Breast Cancer Female, Stress Reaction
- Keywords
- minorities, stress reactivity, allostatic load, disparities
- Medical subject headings
- Fractures, Stress
What is being measured
The primary outcome is the main question the study is designed to answer.
Examine stress reactivity among African American Breast Cancer Survivors utilizing cortisol.
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.
Measured: 21 months
Examine stress reactivity among African American Breast Cancer Survivors utilizing vital signs.
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.
Measured: 21 months
Examine the association between levels of stress reactivity and stressors as it relates to socioeconomic status, clinical factors, and social stress
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.
Measured: 21 months
Examine glucocorticoid sensitivity as a potential predictor of stress reactivity
A blood sample will determine circulating levels of neutrophils, lymphocytes, and monocytes to determine glucocorticoid sensitivity.
Measured: 21 months
Examine stress reactivity on temporal discounting
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.
Measured: 21 months
Determine the extent to which active engagement with a stressor is associated with adherence to dietary recommendations for cancer control
Self-reported diet behaviors will be associated with levels of stress reactivity 1-month following stress induction.
Measured: 1 month
Determine the extent to which active engagement with a stressor is associated with adherence to physical activity recommendations for cancer control
Self-reported physical activity behaviors will be associated with levels of stress reactivity 1-month following stress induction.
Measured: 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Mar 2019
- Study start19 Oct 2018
- Primary completion20 Jul 2021
- Study completion20 Jul 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Breast Cancer FemaleStudies of the same condition, open and under way.
- More trials run by Medical University of South CarolinaThe 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
- 110 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medical University of South Carolina
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03881085
- Sponsor's protocol ID
- AABCSR
- Status last verified
- Jan 2026
- First submitted
- 4 Mar 2019
- Last updated
- 2 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Halbert CH, Jefferson MS, Danielson C, Froeliger B, Giordano A, Thaxton JE. An observational study and randomized trial of stress reactivity in cancer disparities. Health Psychol. 2020 Sep;39(9):745-757. doi: 10.1037/hea0000882.
PubMed 32833476
Study at a glance
From the registry record, last updated by the sponsor on 2 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Science of Behavior Change in African American Breast Cancer Survivors
- ClinicalTrials.gov ID
- NCT03881085
- Acronym / sponsor ID
- AABCSR
- Conditions
- Breast Cancer Female, Stress Reaction
- Keywords
- minorities, stress reactivity, allostatic load, disparities
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 110 participants (actual)
- Lead sponsor
- Medical University of South CarolinaUniversity, hospital or other
- Study start
- 19 Oct 2018 (actual)
- Primary completion
- 20 Jul 2021 (actual)
- Study completion
- 20 Jul 2021 (actual)
- First posted
- 19 Mar 2019 (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.
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.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 21 to 75 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (3 listed)
- Women who are not African American or Black
- Diagnosed with a later stage of breast cancer
- Not within the defined treatment parameters
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
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.
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.
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.
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.
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.
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.
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.
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 2 Feb 2026.
- Derived from this study: PubMed 32833476Halbert CH, Jefferson MS, Danielson C, Froeliger B, Giordano A, Thaxton JE. An observational study and randomized trial of stress reactivity in cancer disparities. Health Psychol. 2020 Sep;39(9):745-757. doi: 10.1037/hea0000882.
- Individual participant dataSharing planned: No
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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 Breast Cancer Female and Stress Reaction, run by Medical University of South Carolina 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 4 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 2 Feb 2026. 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?
Examine stress reactivity among African American Breast Cancer Survivors utilizing cortisol. (time frame: 21 months). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03881085, which also lists 1 linked publication.
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 2 Feb 2026.