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Completed

NCT Number: NCT06219434

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

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

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Key information

Conditions

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

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Thomas Jefferson University Hopsital

Philadelphia, Pennsylvania, 19107, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • Under the age of 18
  • Cannot provide informed consent

Treatment and study plan

Mindfulness Relaxation

Behavioral

Participate in mindfulness program

Other names: MBSR, Mindful Meditation, Mindfulness Meditation, Mindfulness-Based Stress Reduction

functional magnetic resonance imaging

Procedure

Undergo fMRI

Other names: fMRI, FUNCTIONAL MRI

Biospecimen Collection

Procedure

Undergo blood sample collection

Other names: Biological Sample Collection, Biospecimen Collected, Specimen Collection

Questionnaire Administration

Other

Ancillary studies

Primary outcomes

  1. Participation rate

    Time frame: Up to 1 year

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

Sponsors and collaborators

Lead sponsor

Thomas Jefferson University

Other

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2025
Study completion
2025
First posted
Jan 23, 2024
Registry last updated
Dec 8, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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