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

Stanford University

Status: Completed

Conditions: Stage IIIA Breast Cancer; Healthy Subject; Stage IB Breast Cancer; Stage IIIB Breast Cancer; Stage IIB Breast Cancer; Stage IIA Breast Cancer; Stage IIIC Breast Cancer; Stage IA Breast Cancer; Stage 0 Breast Cancer

Treatments: Other: Questionnaire Administration; Procedure: Functional Magnetic Resonance Imaging; Procedure: Biospecimen Collection

Study type: Observational

Funder types: Other; NIH

Identifiers

NCT03050463

U01CA197282 (U.S. NIH Grant/Contract)

IRB-34959

NCI-2016-01547 (Registry Identifier)

BRSADJ0030 (Other Identifier)

Details and patient eligibility

About

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.

Full description

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.

OUTLINE: Study plans to recruit total of 170 women. Participants will be assigned to 3 arms. For women diagnosed with breast cancer (total of 130) 65 with BLM as part of their cancer treatment and 65 non-BLM. The 3rd arm being 40 women with no cancer diagnosis as controls.

Study protocol will be the same for all 170 Study participants. Active participation by each participant will be approximately 8 hours at baseline and 2 hours at 6, 12, and 18-month follow-ups. Baseline assessment involve completing a set of questionnaires, participating in various tasks while undergoing an MRI scan of the head, providing saliva samples and I tube of blood. Follow-up assessments involve completing a set of questionnaires and saliva collection, all can be done at home.

Enrollment: 178 patients

Sex: Female

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

178 participants in 3 patient groups

breast cancer with bilateral mastectomy

Description:

This group has patients with breast cancer who have chosen to have a bilateral mastectomy. Patients complete questionnaires over 1 hour, undergo fMRI related tasks over 2-2.5 hours, and blood/saliva sample collection upon awakening, 30 minutes after awakening, and at 9 pm in the evening for 3 consecutive days.

Treatment:

Procedure: Biospecimen Collection

Procedure: Functional Magnetic Resonance Imaging

Other: Questionnaire Administration

breast cancer without bilateral mastectomy

Description:

This group has patients diagnosed with breast cancer who have chosen not to have bilateral mastectomy (e.g. they may have unilateral mastectomy, lumpectomy, radiation, etc. but not bilateral mastectomy). Patients complete questionnaires over 1 hour, undergo fMRI related tasks over 2-2.5 hours, and blood/saliva sample collection upon awakening, 30 minutes after awakening, and at 9 pm in the evening for 3 consecutive days.

Treatment:

Procedure: Biospecimen Collection

Procedure: Functional Magnetic Resonance Imaging

Other: Questionnaire Administration

healthy subjects

Description:

Patients complete questionnaires over 1 hour, undergo fMRI related tasks over 2-2.5 hours, and blood/saliva sample collection upon awakening, 30 minutes after awakening, and at 9 pm in the evening for 3 consecutive days.

Treatment:

Procedure: Biospecimen Collection

Procedure: Functional Magnetic Resonance Imaging

Other: Questionnaire Administration