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
|Condition or disease|
|Breast Cancer Female Stress Reaction|
|Study Type :||Observational|
|Estimated Enrollment :||120 participants|
|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|
- 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 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.
- 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.
- 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: 21 months ]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: 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
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
|Contact: Chanita Hughes-Halbert, PhDfirstname.lastname@example.org|
|Contact: Melanie S Jefferson, PhDemail@example.com|
|United States, South Carolina|
|Medical University of South Carolina||Recruiting|
|Charleston, South Carolina, United States, 29425|
|Contact: Chanita Hughes-Halbert, PhD 843-876-2421 firstname.lastname@example.org|
|Contact: Melanie Jefferson, PhD 843-876-2430 email@example.com|