Clinical trial · Observational
Functional Magnetic Resonance Imaging in Assessing Affect Reactivity and Regulation in Patients With Stage 0-III Breast Cancer
Impact of Affect Reactivity and Regulation on Breast Cancer Treatment Decisions
NCT03050463CI-TRIAL-00059926completedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (9)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Healthy Subject | — | UNRESOLVED | — |
| Stage 0 Breast Cancer | Malignant Breast Neoplasm | CURATED_BROADER | 0.78 |
| Stage IA Breast Cancer | Malignant Breast Neoplasm | CURATED_BROADER | 0.78 |
| Stage IB Breast Cancer | Malignant Breast Neoplasm | CURATED_BROADER | 0.78 |
| Stage IIA Breast Cancer | Malignant Breast Neoplasm | CURATED_BROADER | 0.78 |
| Stage IIB Breast Cancer | Malignant Breast Neoplasm | CURATED_BROADER | 0.78 |
| Stage IIIA Breast Cancer | Malignant Breast Neoplasm | CURATED_BROADER | 0.78 |
| Stage IIIB Breast Cancer | Malignant Breast Neoplasm | CURATED_BROADER | 0.78 |
| Stage IIIC Breast Cancer | Malignant Breast Neoplasm |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Biospecimen Collection | Procedure | — | UNRESOLVED |
| Functional Magnetic Resonance Imaging | Procedure | — | UNRESOLVED |
| Questionnaire Administration | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (3)
- label
- 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.
- interventionNames
- Procedure: Biospecimen Collection
- Procedure: Functional Magnetic Resonance Imaging
- Other: Questionnaire Administration
- label
- 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.
- interventionNames
- Procedure: Biospecimen Collection
- Procedure: Functional Magnetic Resonance Imaging
- Other: Questionnaire Administration
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (1)
- DERIVEDZhang 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