Functional Magnetic Resonance Imaging in Assessing Affect Reactivity and Regulation in Patients With Stage 0-III Breast Cancer
| Status: | Recruiting |
|---|---|
| Conditions: | Breast Cancer, Cancer, Cancer, Cancer, Cancer, Cancer |
| Therapuetic Areas: | Oncology |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 6/3/2018 |
| Start Date: | August 2016 |
| End Date: | January 2020 |
| Contact: | Bita Nouriani |
| Email: | treatmentdecisionstudy@stanford.edu |
| Phone: | 650-723-8479 |
Impact of Affect Reactivity and Regulation on Breast Cancer Treatment Decisions
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.
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.
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.
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.
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
We found this trial at
1
site
Palo Alto, California 94304
Principal Investigator: David Spiegel
Phone: 650-723-8479
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