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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
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06219434
Enrollment
15
Registered
2024-01-23
Start date
2023-11-13
Completion date
2025-11-03
Last updated
2025-12-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Breast Carcinoma

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.

Interventions

Participate in mindfulness program

PROCEDUREFunctional Magnetic Resonance Imaging

Undergo fMRI

PROCEDUREBiospecimen Collection

Undergo blood sample collection

OTHERQuestionnaire Administration

Ancillary studies

Sponsors

Thomas Jefferson University
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
SUPPORTIVE_CARE
Masking
NONE

Eligibility

Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

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

Exclusion criteria

* Under the age of 18 * Cannot provide informed consent

Design outcomes

Primary

MeasureTime frameDescription
Participation rateUp to 1 yearWill be determined by 75% of the participants will participate in at least 6 of the 8 mindfulness sessions.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026