Functional Magnetic Resonance Imaging in Assessing Affect Reactivity and Regulation in Patients With Stage 0-III Breast Cancer

Trial ID or NCT#

NCT03050463

Status

not recruiting iconNOT RECRUITING

Purpose

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.

Official Title

Impact of Affect Reactivity and Regulation on Breast Cancer Treatment Decisions

Eligibility Criteria

Ages Eligible for Study: Older than 18 Years
Sexes Eligible for Study: Female
Accepts Healthy Volunteers: Yes
Inclusion Criteria:
  1. Women Diagnosed with breast cancer - Female - 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 Controls - Female - 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
Exclusion Criteria:
  1. Women Diagnosed with breast cancer - Other active cancers within the past 10 years other than squamous cell carcinoma of the skin - Pregnant - 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 Controls - Cancer diagnosis, current or past - Pregnant - 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

Investigator(s)

David Spiegel
David Spiegel
Psychiatrist
Jack, Lulu and Sam Willson Professor of Medicine

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Contact

Bita Nouriani
650-723-8479