Clinical trial NCT03050463: Functional Magnetic Resonance Imaging in Assessing Affect Reactivity and Regulation in Patients With Stage 0-III Breast Cancer
Official title: Impact of Affect Reactivity and Regulation on Breast Cancer Treatment Decisions
Study type: OBSERVATIONAL
Overall status: COMPLETED
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
Lead sponsor: Stanford University
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2017-02-13
Enrollment: 178
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: patients with stage 0-III breast cancer at Stanford Cancer Center, as well as healthy subjects

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.

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

Primary outcomes:
measure: Explicit Affect Reactivity and Regulation Measured Using functional MRI (fMRI) Reactivity Probes
timeFrame: Up to 18 months
measure: Implicit Affect Reactivity and Regulation Measured Using fMRI Reactivity Probes
timeFrame: Up to 18 months
Secondary outcomes:
measure: Diurnal Slope of Cortisol
timeFrame: Up to 18 months
measure: BLM decision and affective distress
timeFrame: Up to 18 months
measure: Functional status as a predictor of longitudinal progression
timeFrame: Up to 18 months
Other outcomes:
measure: Choice of BLM and reliance on information from nonmedical sources assessed using the Rosenberg questionnaire
timeFrame: Up to 18 months
Locations:
city: Palo Alto
country: United States
facility: Stanford University, School of Medicine
state: California
Study officials:
affiliation: Stanford University
name: David Spiegel
role: PRINCIPAL_INVESTIGATOR
References: