Healthy SubjectNCT03050463
Functional Magnetic Resonance Imaging in Assessing Affect Reactivity and Regulation in Patients With Stage 0-III Breast Cancer
An observational study of Healthy Subject and Stage 0 Breast Cancer, run by Stanford University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Healthy Subject, Stage 0 Breast Cancer, Stage IA Breast Cancer
- What is being tested?
- Biospecimen Collection, Functional Magnetic Resonance Imaging and Questionnaire Administration
- Type of treatment
- Surgery or procedure
- How many people
- 178 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2016to 8 Jul 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Study population: patients with stage 0-III breast cancer at Stanford Cancer Center, as well as healthy subjects
Who may be able to join
- 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)
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- 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
Who cannot join
- 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
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- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Stanford University, School of Medicine
Palo Alto, California, 94304
About this study
Official title: 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.
Read the detailed description
PRIMARY OBJECTIVES:
- 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:
- 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
- Being tested
- Biospecimen Collection, Functional Magnetic Resonance Imaging, Questionnaire Administration
- Medical subject headings
- Breast Carcinoma In Situ, Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Biospecimen CollectionProcedure or surgery
Undergo blood and saliva sample collection
Functional Magnetic Resonance ImagingProcedure or surgery
Also called fMRI, FUNCTIONAL MRI
Undergo fMRI related tasks
Questionnaire AdministrationOther
Ancillary studies
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: 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. Receives: Procedure: Biospecimen Collection; Procedure: Functional Magnetic Resonance Imaging; Other: Questionnaire Administration |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: Up to 18 months
Secondary outcomes (3)
Diurnal Slope of Cortisol
Affect management is associated with the diurnal slope of cortisol. The stress of a breast cancer diagnosis and subsequent treatment choices is bound to affect hormonal stress response systems, such as the hypothalamic-pituitary-adrenal axis (HPA). Cortisol levels, measured reliably in saliva, are a meaningful and accessible way of assessing physiological stress response. Salient to this study of affect regulation, the investigators have found that flatter diurnal cortisol slope is associated with higher repressive-defensiveness and less sustained expression of primary negative affect in a group setting.
Measured: Up to 18 months
BLM decision and affective distress
Longitudinal trajectories of affective distress are examined. For this, The Contralateral Prophylactic Mastectomy (CPM) survey consists of 23 items related to decision making, knowledge, risk perceptions, and worry about breast cancer. It was developed based on expert knowledge measuring decision making, risk perceptions, and knowledge outcomes in patients with breast cancer. It showed in a recent study that choice of CPM is related to significant anxiety about cancer coupled with overestimation of the risk of recurrence and therefore of the benefit of the procedure. This will be used to study the link between affect reactivity and regulation and cognitive distortion about risks and benefits.
Measured: Up to 18 months
Functional status as a predictor of longitudinal progression
Functional status is assessed through self-report measures. The "Ways of Coping Checklist" was developed to assess eight fundamental dimensions of the coping process: confrontation, distancing, self-control, seeking social support, accepting responsibility, escape/avoidance, planful problem solving, and positive reappraisal. These dimensions measure two general functions of coping, problem-focused coping and emotion-focused coping. Problem-focused coping is aimed at doing something to change the stressful situation for the better, whereas emotion- focused coping is aimed at regulating emotional distress
Measured: Up to 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Feb 2017
- Study startAug 2016
- Primary completion6 Mar 2021
- Study completion8 Jul 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Healthy SubjectStudies of the same condition, open and under way.
- More trials run by Stanford UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 178 participants (actual)
Sponsor and investigators
- Lead sponsor
- Stanford University
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- David Spiegel, Principal investigator, Stanford University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03050463
- Sponsor's protocol ID
- IRB-34959
- Other IDs
- NCI-2016-01547, BRSADJ0030, U01CA197282
- Status last verified
- Jul 2022
- First submitted
- 7 Nov 2016
- Last updated
- 27 Jul 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 37083300
Study at a glance
From the registry record, last updated by the sponsor on 27 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Affect Reactivity and Regulation on Breast Cancer Treatment Decisions
- ClinicalTrials.gov ID
- NCT03050463
- Acronym / sponsor ID
- IRB-34959
- Conditions
- Healthy Subject, Stage 0 Breast Cancer, Stage IA Breast Cancer, Stage IB Breast Cancer, Stage IIA Breast Cancer, Stage IIB Breast Cancer
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 178 participants (actual)
- Lead sponsor
- Stanford UniversityUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- Aug 2016 (actual)
- Primary completion
- 6 Mar 2021 (actual)
- Study completion
- 8 Jul 2021 (actual)
- First posted
- 13 Feb 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- 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:
- 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.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| breast cancer with bilateral mastectomy | – | Procedure: Biospecimen Collection, Procedure: Functional Magnetic Resonance Imaging, Other: Questionnaire AdministrationThis 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. |
| breast cancer without bilateral mastectomy | – | Procedure: Biospecimen Collection, Procedure: Functional Magnetic Resonance Imaging, Other: Questionnaire AdministrationThis 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. |
| healthy subjects | – | Procedure: Biospecimen Collection, Procedure: Functional Magnetic Resonance Imaging, Other: Questionnaire AdministrationPatients 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- patients with stage 0-III breast cancer at Stanford Cancer Center, as well as healthy subjects
Key inclusion criteria (18 listed)
- 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
Key exclusion criteria (16 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Biospecimen CollectionUndergo blood and saliva sample collection | Procedure or surgery | breast cancer with bilateral mastectomy, breast cancer without bilateral mastectomy, healthy subjects |
| Functional Magnetic Resonance ImagingAlso: fMRI, FUNCTIONAL MRIUndergo fMRI related tasks | Procedure or surgery | breast cancer with bilateral mastectomy, breast cancer without bilateral mastectomy, healthy subjects |
| Questionnaire AdministrationAncillary studies | Other | breast cancer with bilateral mastectomy, breast cancer without bilateral mastectomy, healthy subjects |
Primary outcome
Explicit Affect Reactivity and Regulation Measured Using functional MRI (fMRI) Reactivity Probes
Time frame: Up to 18 months
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.
Implicit Affect Reactivity and Regulation Measured Using fMRI Reactivity Probes
Time frame: Up to 18 months
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.
3 secondary outcomes
Diurnal Slope of Cortisol
Time frame: Up to 18 months
BLM decision and affective distress
Time frame: Up to 18 months
Functional status as a predictor of longitudinal progression
Time frame: Up to 18 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jul 2022.
- Derived from this study: PubMed 37083300Zhang 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
David Spiegel principal investigator
Stanford University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Healthy Subject and Stage 0 Breast Cancer, run by Stanford University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 18 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Jul 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Explicit Affect Reactivity and Regulation Measured Using functional MRI (fMRI) Reactivity Probes (time frame: Up to 18 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03050463, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Jul 2022.