Clinical trial NCT03881085: Stress Reactivity Among African American Breast Cancer Survivors
Official title: The Science of Behavior Change in African American Breast Cancer Survivors
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Breast Cancer Female
Stress Reaction
Keywords: minorities
stress reactivity
allostatic load
disparities
Lead sponsor: Medical University of South Carolina
Sponsor class: OTHER
First posted: 2019-03-19
Enrollment: 110
Sex: FEMALE
Minimum age (years): 21
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Examine stress reactivity among African American Breast Cancer Survivors utilizing cortisol.
timeFrame: 21 months
measure: Examine stress reactivity among African American Breast Cancer Survivors utilizing vital signs.
timeFrame: 21 months
measure: Examine the association between levels of stress reactivity and stressors as it relates to socioeconomic status, clinical factors, and social stress
timeFrame: 21 months
measure: Examine glucocorticoid sensitivity as a potential predictor of stress reactivity
timeFrame: 21 months
measure: Examine stress reactivity on temporal discounting
timeFrame: 21 months
measure: Determine the extent to which active engagement with a stressor is associated with adherence to dietary recommendations for cancer control
timeFrame: 1 month
measure: Determine the extent to which active engagement with a stressor is associated with adherence to physical activity recommendations for cancer control
timeFrame: 1 month
Secondary outcomes:
Other outcomes:
Locations:
city: Charleston
country: United States
facility: Medical University of South Carolina
state: South Carolina
Study officials:
References:
citation: 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.