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

Not Recruiting

Trial ID: NCT03050463

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

Stanford Investigator(s)

David Spiegel
David Spiegel

Jack, Lulu and Sam Willson Professor of Medicine

Eligibility


Inclusion Criteria:

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:

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

Intervention(s):

procedure: Biospecimen Collection

procedure: Functional Magnetic Resonance Imaging

other: Questionnaire Administration

Not Recruiting

Contact Information

Stanford University
School of Medicine
300 Pasteur Drive
Stanford, CA 94305
Bita Nouriani
650-723-8479

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