Impact of Affect Reactivity and Regulation on Breast Cancer Treatment Decisions
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 178
- 试验地点
- 1
- 主要终点
- Implicit Affect Reactivity and Regulation Measured Using fMRI Reactivity Probes
研究概览
简要总结
The investigators hope to gain a better understanding of the influence of affect reactivity and regulation on the decision of newly diagnosed breast cancer patients to choose bilateral mastectomy. The information gained can help develop an intervention to enable management of cancer-related anxiety by non-surgical means.
详细描述
PRIMARY OBJECTIVES:
I. Examine affect reactivity and regulation among women with a recent diagnosis of breast cancer in comparison to healthy controls.
II. Relate affect reactivity and regulation to choice of bilateral mastectomy (BLM).
SECONDARY OBJECTIVES:
I. Assess long term functioning correlates of BLM decision and affect reactivity and regulation.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Prospective
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
- •Women Diagnosed with breast cancer
- •Age 18 or older
- •Agree to suspend treatments containing Benzodiazepines and steroids up to 2 weeks pre and during cortisol sampling (based on PI's clinical judgement)
- •Agree to taking saliva samples and having fMRI scan
- •No contraindications to MRI imaging (like ferromagnetic metal in their body)
- •Proficiency in English sufficient to complete questionnaires and follow instructions during the fMRI assessments
- •US Citizen or resident able to receive payment legally
- •Documented stage 0-III breast cancer
- •Unilateral breast tumors
- •Age 18 or older
- •Agree to suspend treatments containing Benzodiazepines and steroids up to 2 weeks pre and during cortisol sampling (based on PI's clinical judgement)
- •Agree to having saliva samples and fMRI scan
- •No contraindications to MRI imaging (like ferromagnetic metal in their body)
- •Proficiency in English sufficient to complete questionnaires and follow instructions during the fMRI assessments
- •US Citizen or resident able to receive payment legally
排除标准
- •Women Diagnosed with breast cancer
- •Other active cancers within the past 10 years other than squamous cell carcinoma of the skin
- •Any significant neurologic disease, such as dementia, multi-infarct dementia, Parkinson's or Huntington's disease, brain tumor, progressive supranuclear palsy, seizure disorder, subdural hematoma, multiple sclerosis, stroke, or traumatic brain injury
- •Hearing impaired
- •Current untreated psychosis, or bipolar disorder, or substance/alcohol abuse/dependence
- •Current use of psychotropic (based on PI's clinical judgement) medication 5 or more days a week
- •Cancer diagnosis, current or past
- •Any significant neurologic disease, such as dementia, multi-infarct dementia, Parkinson's or Huntington's disease, brain tumor, progressive supranuclear palsy, seizure disorder, subdural hematoma, multiple sclerosis, stroke, or traumatic brain injury
- •Hearing impaired
- •Current untreated psychosis, or bipolar disorder, or substance/alcohol abuse/dependence
- •Current use of psychotropic (based on PI's clinical judgement) medication 5 or more days a week
- •Breast cancer diagnosis in 1 first degree relative or 2 or more second degree relatives
- •Ovarian cancer diagnosis in 1 first or second degree relative
结局指标
主要结局
Implicit Affect Reactivity and Regulation Measured Using fMRI Reactivity Probes
时间窗: Up to 18 months
Multivariate regression analysis will be used to examine affect reactivity among women with a recent diagnosis of breast cancer in comparison to healthy controls at baseline. Functional data will be collected on the implicit affect regulation task (13 minutes) and implicit cancer-related affect regulation task (13 minutes). Affect reactivity and cancer-related affect reactivity will be defined by incongruent minus congruent trials and incongruent cancer minus congruent cancer-related trials. The greater this value, the more affect reactivity there is. Implicit affect regulation for general affective content will be calculated by post-congruent incongruent trials minus post-incongruent incongruent trials. Similarly, implicit affect regulation for cancer related content will be calculated from the post-congruent incongruent trials minus post-incongruent incongruent trials in the cancer-related adaptation of the task. The greater this value, the less successful implicit regulation is.
Explicit Affect Reactivity and Regulation Measured Using functional MRI (fMRI) Reactivity Probes
时间窗: Up to 18 months
Multivariate regression analysis will be used to examine affect reactivity among women with a recent diagnosis of breast cancer in comparison to healthy controls at baseline. Functional data will be collected on the explicit affect regulation task (20 minutes) and explicit cancer related affect regulation task (8 minutes). Affect reactivity and cancer-related affect reactivity will be defined by WATCH negative minus WATCH neutral and by WATCH cancer-related negative and WATCH neutral contrast. The larger this value, the greater the affect reactivity. Explicit affect regulation will defined by WATCH negative minus REAPPRAISE negative, and by WATCH negative minus REAPPRAISE cancer-related negative contrasts. The greater this value, the less successful explicit regulation is.
次要结局
- Diurnal Slope of Cortisol(Up to 18 months)
- BLM decision and affective distress(Up to 18 months)
- Functional status as a predictor of longitudinal progression(Up to 18 months)