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Stress Reactivity Among African American Breast Cancer Survivors

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ClinicalTrials.gov Identifier: NCT03881085
Recruitment Status : Recruiting
First Posted : March 19, 2019
Last Update Posted : March 19, 2019
Sponsor:
Information provided by (Responsible Party):
Chanita Hughes Halbert, Medical University of South Carolina

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.

Condition or disease
Breast Cancer Female Stress Reaction

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.

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Study Type : Observational
Estimated Enrollment : 120 participants
Observational Model: Cohort
Time Perspective: Retrospective
Official Title: The Science of Behavior Change in African American Breast Cancer Survivors
Actual Study Start Date : October 19, 2018
Estimated Primary Completion Date : August 31, 2020
Estimated Study Completion Date : September 14, 2020

Resource links provided by the National Library of Medicine





Primary Outcome Measures :
  1. 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.

  2. 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.

  3. Examine the association between levels of stress reactivity and stressors as it relates to socioeconomic status, clinical factors, and social stressors [ 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.

  4. Examine glucocorticoid sensitivity as a potential predictor of stress reactivity [ Time Frame: 21 months ]
    An overnight urine collection sample will determine circulating levels of neutrophils, lymphpcytes, and monocytes to determine glucocorticoid sensitivity.

  5. 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.

  6. Determine the extent to which active engagement with a stressor is associated with adherence to dietary recommendations for cancer control [ Time Frame: 21 months ]
    Self-reported diet behaviors will be associated with levels of stress reactivity 1-month following stress induction.

  7. Determine the extent to which active engagement with a stressor is associated with adherence to physical activity recommendations for cancer control [ Time Frame: 21 months ]
    Self-reported physical activity behaviors will be associated with levels of stress reactivity 1-month following stress induction.


Biospecimen Retention:   Samples With DNA
Blood samples, urine samples, and saliva samples


Information from the National Library of Medicine

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Ages Eligible for Study:   21 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Gender Based Eligibility:   Yes
Gender Eligibility Description:   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.
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.
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03881085


Contacts
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Contact: Chanita Hughes-Halbert, PhD 843-876-2421 hughesha@musc.edu
Contact: Melanie S Jefferson, PhD 843-876-2430 sweatma@musc.edu

Locations
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United States, South Carolina
Medical University of South Carolina Recruiting
Charleston, South Carolina, United States, 29425
Contact: Chanita Hughes-Halbert, PhD    843-876-2421    hughesha@musc.edu   
Contact: Melanie Jefferson, PhD    843-876-2430    sweatma@musc.edu   
Sponsors and Collaborators
Medical University of South Carolina
  Study Documents (Full-Text)

Documents provided by Chanita Hughes Halbert, Medical University of South Carolina:

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Responsible Party: Chanita Hughes Halbert, Principal Investigator, Medical University of South Carolina
ClinicalTrials.gov Identifier: NCT03881085     History of Changes
Other Study ID Numbers: AABCSR
First Posted: March 19, 2019    Key Record Dates
Last Update Posted: March 19, 2019
Last Verified: March 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Chanita Hughes Halbert, Medical University of South Carolina:
minorities
stress reactivity
allostatic load
disparities

Additional relevant MeSH terms:
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Breast Neoplasms
Fractures, Stress
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Fractures, Bone
Wounds and Injuries