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

NCT06219434 | Completed

• 2 other identifiers: iRISID-2023-2430JT 32145
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

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

Conditions

Breast Carcinoma

Outcome Measures

Primary Outcomes (1)

• Participation rate

  Will be determined by 75% of the participants will participate in at least 6 of the 8 mindfulness sessions.

  Up to 1 year

Study Arms (1)

Supportive care (mindfulness program)

EXPERIMENTAL

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.

Behavioral: Mindfulness Relaxation; Procedure: Functional Magnetic Resonance Imaging; Procedure: Biospecimen Collection; Other: Questionnaire Administration

Interventions

Mindfulness Relaxation BEHAVIORAL

Participate in mindfulness program

Also known as: MBSR, Mindful Meditation, Mindfulness Meditation, Mindfulness-Based Stress Reduction

Supportive care (mindfulness program)

Functional Magnetic Resonance Imaging PROCEDURE

Undergo fMRI

Also known as: fMRI, FUNCTIONAL MRI

Supportive care (mindfulness program)

Biospecimen Collection PROCEDURE

Undergo blood sample collection

Also known as: Biological Sample Collection, Biospecimen Collected, Specimen Collection

Supportive care (mindfulness program)

Questionnaire Administration OTHER

Ancillary studies

Supportive care (mindfulness program)

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• Under the age of 18
• Cannot provide informed consent

Sponsors & Collaborators

• Thomas Jefferson University: lead

Study Sites (1)

Thomas Jefferson University Hopsital

Philadelphia, Pennsylvania, 19107, United States

Location

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Mindfulness; Mindfulness-Based Stress Reduction; Specimen Handling

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Cognitive Behavioral Therapy; Behavior Therapy; Psychotherapy; Behavioral Disciplines and Activities; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Investigative Techniques

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 12, 2024
• First Posted: January 23, 2024
• Study Start: November 13, 2023
• Primary Completion: August 14, 2025
• Study Completion: November 3, 2025
• Last Updated: December 8, 2025

Record last verified: 2025-12

Locations

US (1)