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

NCT ID: NCT03050463

Last Updated: 2022-07-27

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 178 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2016-08-31
• Study Completion Date: 2021-07-08

Brief 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.

Detailed 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.

Conditions

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

Study Design

• Observational Model Type: CASE_CONTROL
• Study Time Perspective: PROSPECTIVE

Study Groups

breast cancer with bilateral mastectomy

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.

Biospecimen Collection

Intervention Type: PROCEDURE

Undergo blood and saliva sample collection

Functional Magnetic Resonance Imaging

Intervention Type: PROCEDURE

Undergo fMRI related tasks

Questionnaire Administration

Intervention Type: OTHER

Ancillary studies

breast cancer without bilateral mastectomy

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.

Biospecimen Collection

Intervention Type: PROCEDURE

Undergo blood and saliva sample collection

Functional Magnetic Resonance Imaging

Intervention Type: PROCEDURE

Undergo fMRI related tasks

Questionnaire Administration

Intervention Type: OTHER

Ancillary studies

healthy subjects

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.

Biospecimen Collection

Intervention Type: PROCEDURE

Undergo blood and saliva sample collection

Functional Magnetic Resonance Imaging

Intervention Type: PROCEDURE

Undergo fMRI related tasks

Questionnaire Administration

Intervention Type: OTHER

Ancillary studies

Interventions

Biospecimen Collection

Undergo blood and saliva sample collection

Intervention Type: PROCEDURE

Functional Magnetic Resonance Imaging

Undergo fMRI related tasks

Intervention Type: PROCEDURE

Questionnaire Administration

Ancillary studies

Intervention Type: OTHER

Other Intervention Names

fMRI; FUNCTIONAL MRI

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

National Cancer Institute (NCI)

NIH

Sponsor Role: collaborator

Stanford University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

David Spiegel

Role: PRINCIPAL_INVESTIGATOR

Stanford University

Locations

Stanford University, School of Medicine

Palo Alto, California, United States

Countries

United States

References

Zhang JX, Kurian AW, Jo B, Nouriani B, Neri E, Gross JJ, Spiegel D. Emotion regulation and choice of bilateral mastectomy for the treatment of unilateral breast cancer. Cancer Med. 2023 Jun;12(11):12837-12846. doi: 10.1002/cam4.5963. Epub 2023 Apr 21.

Reference Type: DERIVED

PMID: 37083300 (View on PubMed)

Provided Documents

Document Type: Informed Consent Form

View Document

Other Identifiers

NCI-2016-01547

Identifier Type: REGISTRY

Identifier Source: secondary_id

BRSADJ0030

Identifier Type: OTHER

Identifier Source: secondary_id

U01CA197282

Identifier Type: NIH

Identifier Source: secondary_id

View Link

IRB-34959

Identifier Type: -

Identifier Source: org_study_id