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

Thomas Jefferson University

Status: Enrolling

Conditions: Breast Carcinoma

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

Study type: Interventional

Funder types: Other

Identifiers

NCT06219434

iRISID-2023-2430

Details and patient eligibility

About

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

Full 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.

Enrollment: 12 estimated patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

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

Exclusion criteria

• Under the age of 18
• Cannot provide informed consent

Trial design

Primary purpose: Supportive Care

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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12 participants in 1 patient group

Supportive care (mindfulness program)

Experimental group

Description:

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.

Treatment:

Behavioral: Mindfulness Relaxation

Procedure: Biospecimen Collection

Other: Questionnaire Administration

Procedure: Functional Magnetic Resonance Imaging