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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT06219434
Other study ID # iRISID-2023-2430
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
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
Health authority
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

Study Design


Related Conditions & MeSH terms


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
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