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 range

18 Years

Sex

FEMALE

See this in plain English?

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…

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Explicit Affect Reactivity and Regulation Measured Using functional MRI (fMRI) Reactivity Probes

Timeframe: Up to 18 months

Implicit Affect Reactivity and Regulation Measured Using fMRI Reactivity Probes

Timeframe: Up to 18 months

Trial details

NCT IDNCT03050463

SponsorStanford University

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2021-03-06

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