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Supportive care (mindfulness program) for Breast Cancer

N/A

Recruiting

Research Sponsored by Thomas Jefferson University

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Breast cancer diagnosis preparing to undergo chemotherapy

18 years or older

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 1 year

Awards & highlights

Study Summary

This trial is testing if practicing mindfulness can help prevent cognitive dysfunction, also known as chemo-brain, in women with breast cancer who are about to undergo chemotherapy. Chemo-brain is a well

Who is the study for?

This trial is for women preparing to undergo chemotherapy for breast cancer. It aims to see if mindfulness meditation can prevent 'chemo-brain', a condition where patients experience cognitive issues after chemo.Check my eligibility

What is being tested?

The study tests a mindfulness intervention against the occurrence of 'chemo-brain'. Participants will practice mindfulness, have their brain structure and function assessed via MRI, and complete questionnaires about their cognitive function.See study design

What are the potential side effects?

Mindfulness practices are generally considered safe with no significant side effects; however, some individuals may experience increased emotional sensitivity or distress during meditation.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I have breast cancer and am about to start chemotherapy.

Select...

I am 18 years old or older.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 1 year

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 1 year

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 1 year for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Participation rate

Trial Design

1Treatment groups

Experimental Treatment

Group I: Supportive care (mindfulness program)Experimental Treatment4 Interventions

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

First Studied

Drug Approval Stage

How many patients have taken this drug

Functional Magnetic Resonance Imaging

2016

Completed Phase 4

~890

Biospecimen Collection

2004

Completed Phase 2

~1700

0 / 2Eligibility criteria met

Find a Location

Who is running the clinical trial?

Thomas Jefferson UniversityLead Sponsor

445 Previous Clinical Trials

145,477 Total Patients Enrolled

5 Trials studying Breast Cancer

607 Patients Enrolled for Breast Cancer

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are participants being actively sought for this ongoing research study?

"Indeed, according to clinicaltrials.gov, this trial is presently recruiting participants. The initial posting was on November 13th, 2023 and the most recent update occurred on January 12th, 2024. A total of twelve individuals are sought for enrollment from a single site."

Answered by AI

What is the current number of individuals being recruited for participation in this clinical study?

"Indeed, according to the information available on clinicaltrials.gov, this particular medical trial is actively seeking eligible participants. The trial was initially posted on November 13th, 2023 and last updated on January 12th, 2024. There is a need for a total of 12 patients who will be recruited from one location."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

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

2023. "Evaluation of a Mindfulness Intervention to Prevent Chemo-brain in Women Preparing for Chemotherapy for Breast Cancer". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06219434.