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

Not Applicable

Recruiting

• Conditions: Breast Carcinoma
• Interventions: Behavioral: Mindfulness Relaxation; Procedure: Functional Magnetic Resonance Imaging; Procedure: Biospecimen Collection; Other: Questionnaire Administration

• Registration Number: NCT06219434
• Lead Sponsor: Thomas Jefferson University

Brief 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.

Study Timeline

• Study Start: 2023-11-13
• Study First Submitted: 2024-01-12
• Study First Submitted QC: 2024-01-12
• Study First Posted: 2024-01-23
• Status Verified: 2025-01
• Last Update Submitted: 2025-01-02
• Last Update Posted: 2025-01-03
• Primary Completion: 2025-10-01
• Study Completion: 2025-10-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 12

Inclusion Criteria

• 18 years or older
• Breast cancer diagnosis preparing to undergo chemotherapy

Exclusion Criteria

• Under the age of 18
• Cannot provide informed consent

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Supportive care (mindfulness program)	Functional Magnetic Resonance Imaging	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.
Supportive care (mindfulness program)	Questionnaire Administration	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.
Supportive care (mindfulness program)	Mindfulness Relaxation	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.
Supportive care (mindfulness program)	Biospecimen Collection	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.

Primary Outcome Measures

Name	Time	Method
Participation rate	Up to 1 year	Will be determined by 75% of the participants will participate in at least 6 of the 8 mindfulness sessions.

Trial Locations

Locations (1)

Thomas Jefferson University Hopsital; 🇺🇸 Philadelphia, Pennsylvania, United States