Clinical Trial Details
— Status: Completed
Administrative data
NCT number |
NCT03881085 |
Other study ID # |
AABCSR |
Secondary ID |
|
Status |
Completed |
Phase |
|
First received |
|
Last updated |
|
Start date |
October 19, 2018 |
Est. completion date |
July 20, 2021 |
Study information
Verified date |
May 2022 |
Source |
Medical University of South Carolina |
Contact |
n/a |
Is FDA regulated |
No |
Health authority |
|
Study type |
Observational
|
Clinical 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. 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.
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.