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

Breast Carcinoma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06219434
• Other study ID #: iRISID-2023-2430
• Status: Recruiting
• Phase: N/A
• Start date: November 13, 2023
• Est. completion date: October 1, 2024

Study information

• Verified date: May 2024
• Source: Thomas Jefferson University
• Contact: Ana maria Lopez, MD
• Phone: 215-503-7917
• Email: AnaMaria.Lopez[@]jefferson.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 12
• Est. completion date: October 1, 2024
• Est. primary completion date: October 1, 2024
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• 18 years or older

• Breast cancer diagnosis preparing to undergo chemotherapy

Exclusion Criteria:

• Under the age of 18

• Cannot provide informed consent

Related Conditions & MeSH terms

• Breast Carcinoma
• Breast Neoplasms

Intervention

Behavioral:
• Mindfulness Relaxation
Participate in mindfulness program

Procedure:
• Functional Magnetic Resonance Imaging
Undergo fMRI
• Biospecimen Collection
Undergo blood sample collection

Other:
• Questionnaire Administration
Ancillary studies

Locations

Country	Name	City	State
United States	Thomas Jefferson University Hopsital	Philadelphia	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
Thomas Jefferson University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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