Functional Magnetic Resonance Imaging in Assessing Affect Reactivity and Regulation in Patients W… (NCT03050463) | Clinical Trial Compass
CompletedNot Applicable
Functional Magnetic Resonance Imaging in Assessing Affect Reactivity and Regulation in Patients With Stage 0-III Breast Cancer
United States178 participantsStarted 2016-08
Plain-language summary
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.
Who can participate
Age range18 Years
SexFEMALE
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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 b…
What they're measuring
1
Explicit Affect Reactivity and Regulation Measured Using functional MRI (fMRI) Reactivity Probes
Timeframe: Up to 18 months
2
Implicit Affect Reactivity and Regulation Measured Using fMRI Reactivity Probes