Stress Reactivity Among African American Breast Cancer Survivors

NCT03881085 | Completed

• 1 other identifier: AABCSR
• Study Type: observational
• Target: 110
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Breast Cancer Female; Stress Reaction

Keywords

minorities; stress reactivity; allostatic load; disparities

Outcome Measures

Primary Outcomes (7)

• 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.

  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.

  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.

  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.

  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.

  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.

  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.

  1 month

Eligibility Criteria

• Age: 21 Years - 75 Years
• Gender Eligibility Details: Due to the nature of this study, only women who were born biologically as female will be eligible to participate in this study. Men who develop breast cancer have a different pathophysiology than women, and therefore, will not be included in this sample.
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• Women who are not African American or Black
• Diagnosed with a later stage of breast cancer
• Not within the defined treatment parameters

Sponsors & Collaborators

• Medical University of South Carolina: lead

Study Sites (1)

Medical University of South Carolina

Charleston, South Carolina, 29425, United States

Location

Related Publications (1)

• 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.

  PMID: 32833476 DERIVED

Biospecimen

Retention: SAMPLES WITH DNA

Blood samples, urine samples, and saliva samples

MeSH Terms

Conditions

Fractures, Stress

Condition Hierarchy (Ancestors)

Fractures, Bone; Wounds and Injuries

Study Design

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

Study Record Dates

• First Submitted: March 4, 2019
• First Posted: March 19, 2019
• Study Start: October 19, 2018
• Primary Completion: July 20, 2021
• Study Completion: July 20, 2021
• Last Updated: February 2, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)