NCT06219434

Evaluation of a Mindfulness Intervention to Prevent Chemo-brain in Women Preparing for Chemotherapy for Breast Cancer

Pilot Feasibility Evaluation of a Mindfulness (Mindfulness) Intervention in Women Preparing for Chemotherapy for Breast Cancer

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 15 (actual)
• Sponsor: Thomas Jefferson University · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Detailed 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.

Conditions

• Breast Carcinoma

Interventions

Type	Name	Description
BEHAVIORAL	Mindfulness Relaxation	Participate in mindfulness program
PROCEDURE	Functional Magnetic Resonance Imaging	Undergo fMRI
PROCEDURE	Biospecimen Collection	Undergo blood sample collection
OTHER	Questionnaire Administration	Ancillary studies

Timeline

• Start date: 2023-11-13
• Primary completion: 2025-08-14
• Completion: 2025-11-03
• First posted: 2024-01-23
• Last updated: 2025-12-08

Locations

1 site across 1 country: United States