Impact of Affect Reactivity and Regulation on Breast Cancer Treatment Decisions
Sponsor study identifier
Secondary identifiers
REGISTRY · CTRP (Clinical Trial Reporting Program)
OTHER · OnCore
NIH
observational
178
1 country
1
Study Start
August 2016
Actual (reported)Primary Completion
March 6, 2021
Actual (reported)Study Completion
July 8, 2021
Actual (reported)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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
July 8, 2021
Actual (reported)Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
August 2016
Actual (reported)November 7, 2016
Actual (reported)February 13, 2017
Actual (reported)March 6, 2021
Actual (reported)July 8, 2021
Actual (reported)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.
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.
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.
Undergo blood and saliva sample collection
Undergo fMRI related tasks
patients with stage 0-III breast cancer at Stanford Cancer Center, as well as healthy subjects
Stanford University, School of Medicine
Palo Alto, California, 94304, United States
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.
blood and saliva
David Spiegel
Stanford University
178 participants (actual enrollment reported by the registry).
First Submitted
November 7, 2016
First Posted
February 13, 2017
Study Start
August 2016
Actual (reported)Up to 18 months
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
Choice of BLM and reliance on information from nonmedical sources assessed using the Rosenberg questionnaire
Up to 18 months
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.
Ancillary studies
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Primary Completion
March 6, 2021
Actual (reported)Study Completion
July 8, 2021
Actual (reported)Last Updated
July 27, 2022
Record last verified: 2022-07
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Source: ClinicalTrials.gov.
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