GEM: A Single-Arm Trial Assessing Feasibility of Allostatic Load Biomarkers and CVD Risk Among Black Breast Cancer Survivors
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 入组人数
- 25
- 主要终点
- Feasibility
研究概览
简要总结
This study's overall objective is to test the effects of a culturally tailored gratitude, exercise, and mindfulness/emotional freedom techniques (GEM) psychosocial intervention on allostatic load and atherosclerotic cardiovascular disease risk in black women breast Cancer survivors. Allostatic load refers to the cumulative physiological burden of chronic stress, which is a major contributor to CVD risk, impaired immune function, and worse cancer outcomes. Atherosclerotic cardiovascular disease risk encompasses factors such as blood pressure, cholesterol, and glucose control that predict long-term cardiovascular health.
Among survivors of breast cancer in the U.S., black women have the highest rates of mortality from breast cancer, cardiometabolic disease, and all causes. These disparities are likely due to complex interactions between socioeconomic, psychosocial, and biological risk factors. A higher prevalence of cardiometabolic risk factors among black women breast cancer survivors is one critical disparity associated with poorer breast cancer outcomes and increased cardiometabolic risk, including that driven by cardiotoxicity from breast cancer treatment. Engagement in physical activity, which reduces cardiometabolic risk, is associated with significant reductions in all-cause and cancer mortality in breast cancer survivors. However, black breast cancer survivors report lower levels of physical activity compared to their white counterparts, and most interventions targeting this behavior have not effectively engaged black women. Interventions that effectively increase physical activity in black women breast cancer survivors hold promise as a means for reducing these persistent disparities in survival outcomes.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —(Adult, Older Adult)
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Participants must identify as Black women who have survived breast cancer
- •Participants must have completed primary cancer treatment (surgery, chemotherapy, and/or radiation) at least 6 months prior to enrollment
- •Adults ≥ 18 years old
- •Capable of completing study requirements
- •Informed consent obtained from the participant and documentation of participant agreement to comply with all study-related processes
排除标准
- •Females who are pregnant or breastfeeding
- •Prisoners or subjects who are involuntarily incarcerated, or subjects who are compulsorily detained for treatment of either a psychiatric or physical illness.
- •Impaired cognition (i.e., inability to follow and respond appropriately during screening).
- •Participants currently enrolled in other lifestyle, exercise, or psychosocial interventions will be excluded.
研究组 & 干预措施
Gratitude, exercise and mindfulness program
干预措施: Gratitude, exercise, and mindfulness program (Behavioral)
结局指标
主要结局
Feasibility
时间窗: 8 months
Determine the feasibility of collecting a comprehensive panel of allostatic load biomarkers and atherosclerotic cardiovascular disease risk components. This will be measured by the number of subjects who successfully complete the baseline assessments, which include self-reported questionnaires and biomarker collection, participate in a minimum number of 6 of 8 intervention sessions, and complete the post-intervention assessments, including follow-up questionnaires and biomarker collection.
次要结局
- Difference in hemoglobin A1c(8 weeks)
- Difference in total cholesterol(8 weeks)
- Difference in LDL(8 weeks)
- Difference in HDL(8 weeks)
- Difference in fasting glucose(8 weeks)
- Difference in C-reactive protein(8 weeks)
- Difference in cortisol(8 weeks)
- Difference in glomerular filtration rate(8 weeks)
- Difference in albumin to creatinine ratio(8 weeks)
- Difference in Gratitude Questionnaire-6 score(8 months)
- Difference in International Physical Activity Questionnaire score(8 months)
- Difference in The Gratitude Questionnaire-Six Item Form score(8 months)
- Difference in Functional Assessment of Chronic Illness Therapy-Spiritual Well-Being Scale (FACTIT-Sp) score(8 months)
- Difference in General Self-Efficacy Scale score(8 months)
- Difference in Superwoman Schema score(8 months)
- Difference in Perceived Stress Scale score(8 months)
