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

NCT03050463 | Completed DMC

• 4 other identifiers: IRB-34959NCI-2016-01547BRSADJ0030U01CA197282
• Study Type: observational
• Target: 178
• Locations: 1 country
• Sites: 1

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.

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

Outcome Measures

Primary Outcomes (2)

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

  Multivariate regression analysis will be used to examine affect reactivity among women with a recent diagnosis of breast cancer in comparison to healthy controls at baseline. Functional data will be collected on the explicit affect regulation task (20 minutes) and explicit cancer related affect regulation task (8 minutes). Affect reactivity and cancer-related affect reactivity will be defined by WATCH negative minus WATCH neutral and by WATCH cancer-related negative and WATCH neutral contrast. The larger this value, the greater the affect reactivity. Explicit affect regulation will defined by WATCH negative minus REAPPRAISE negative, and by WATCH negative minus REAPPRAISE cancer-related negative contrasts. The greater this value, the less successful explicit regulation is.

  Up to 18 months

• Implicit Affect Reactivity and Regulation Measured Using fMRI Reactivity Probes

  Multivariate regression analysis will be used to examine affect reactivity among women with a recent diagnosis of breast cancer in comparison to healthy controls at baseline. Functional data will be collected on the implicit affect regulation task (13 minutes) and implicit cancer-related affect regulation task (13 minutes). Affect reactivity and cancer-related affect reactivity will be defined by incongruent minus congruent trials and incongruent cancer minus congruent cancer-related trials. The greater this value, the more affect reactivity there is. Implicit affect regulation for general affective content will be calculated by post-congruent incongruent trials minus post-incongruent incongruent trials. Similarly, implicit affect regulation for cancer related content will be calculated from the post-congruent incongruent trials minus post-incongruent incongruent trials in the cancer-related adaptation of the task. The greater this value, the less successful implicit regulation is.

  Up to 18 months

Secondary Outcomes (3)

• Diurnal Slope of Cortisol

  Up to 18 months

• BLM decision and affective distress

  Up to 18 months

• Functional status as a predictor of longitudinal progression

  Up to 18 months

Other Outcomes (1)

• Choice of BLM and reliance on information from nonmedical sources assessed using the Rosenberg questionnaire

  Up to 18 months

Study Arms (3)

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.

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

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.

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

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.

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

Interventions

Biospecimen Collection PROCEDURE

Undergo blood and saliva sample collection

breast cancer with bilateral mastectomy; breast cancer without bilateral mastectomy; healthy subjects

Functional Magnetic Resonance Imaging PROCEDURE

Undergo fMRI related tasks

Also known as: fMRI, FUNCTIONAL MRI

breast cancer with bilateral mastectomy; breast cancer without bilateral mastectomy; healthy subjects

Questionnaire Administration OTHER

Ancillary studies

breast cancer with bilateral mastectomy; breast cancer without bilateral mastectomy; healthy subjects

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

patients with stage 0-III breast cancer at Stanford Cancer Center, as well as healthy subjects

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Stanford University: lead
• National Cancer Institute (NCI): collaborator

Study Sites (1)

Stanford University, School of Medicine

Palo Alto, California, 94304, United States

Location

Related Publications (1)

• 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.

  PMID: 37083300 DERIVED

Biospecimen

Retention: SAMPLES WITH DNA

blood and saliva

MeSH Terms

Conditions

Breast Carcinoma In Situ; Breast Neoplasms

Condition Hierarchy (Ancestors)

Carcinoma in Situ; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Neoplasms by Site; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• David Spiegel

  Stanford University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 7, 2016
• First Posted: February 13, 2017
• Study Start: August 1, 2016
• Primary Completion: March 6, 2021
• Study Completion: July 8, 2021
• Last Updated: July 27, 2022

Record last verified: 2022-07

Locations

US (1)