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Clinical Trial Summary

This clinical trial tests how well a mindfulness intervention helps the prevention of chemotherapy-brain (chemo-brain) in women preparing for chemotherapy for breast cancer. Cognitive dysfunction after chemotherapy has been well-documented. Factors that have been used to document and/or have been correlated with chemo brain include self-report and structural brain changes including volume loss. Mindfulness is a type of meditation practice that can be learned to support well-being and decrease stress. Mindfulness is an approach that helps the person increase their awareness of the present moment without judgement. There are data that mindfulness may increase attention and concentration which may prevent some of the side effects from chemotherapy


Clinical Trial Description

PRIMARY OBJECTIVES: I. Assess the feasibility of an 8-week mindfulness intervention in women preparing for chemotherapy for breast cancer. II. Evaluate cognitive dysfunction related factors as an exploratory objective: cognitive function, quality of life, inflammatory markers, functional magnetic resonance imaging (fMRI) brain imaging, and a record of mindfulness practice. OUTLINE: Patients participate in a mindfulness program composed of topics that include mindfulness of breathing and the body scan, mindful eating, mindful activity, mindfulness in daily life, expanding the field of awareness, and maintaining a flexible mindfulness practice weekly over 2.5 hours for 8 weeks. Patients also undergo blood sample collection and fMRI on the study. After completion of study intervention, patients are followed up at 3 months. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT06219434
Study type Interventional
Source Thomas Jefferson University
Contact Ana maria Lopez, MD
Phone 215-503-7917
Email AnaMaria.Lopez@jefferson.edu
Status Recruiting
Phase N/A
Start date November 13, 2023
Completion date October 1, 2024

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