NCT03050463

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

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 178 (actual)
• Sponsor: Stanford University · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Accepted

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.

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

Interventions

Type	Name	Description
PROCEDURE	Biospecimen Collection	Undergo blood and saliva sample collection
PROCEDURE	Functional Magnetic Resonance Imaging	Undergo fMRI related tasks
OTHER	Questionnaire Administration	Ancillary studies

Timeline

• Start date: 2016-08-01
• Primary completion: 2021-03-06
• Completion: 2021-07-08
• First posted: 2017-02-13
• Last updated: 2022-07-27

Locations

1 site across 1 country: United States