Status:
ACTIVE_NOT_RECRUITING
An Early Stress-Reduction Intervention in Patients With Newly Diagnosed Breast Cancer
Lead Sponsor:
M.D. Anderson Cancer Center
Collaborating Sponsors:
Hackett Foundation
Conditions:
Malignant Neoplasm of Breast
Eligibility:
FEMALE
18+ years
Phase:
NA
Brief Summary
The goal of this research study is to learn if starting a stress-reduction program before treatment can affect your stress, mood, and physical symptoms during and after treatment for cancer. This is ...
Detailed Description
Study Groups: If you agree to take part in this study, you will be randomly assigned (as in the flip of a coin) to 1 of 2 groups. You will have an equal chance of being in either group: * If you are...
Eligibility Criteria
Inclusion
- Women with stage I-III breast cancer who are followed by the Department of Breast Medical Oncology and are recommended for neoadjuvant chemotherapy, any regimen. If chemotherapy is received in an outside facility, patients are eligible if they are scheduled to return to MD Anderson after completion of chemotherapy.
- Patients = or \> 18 years old
- Patients who speak English
- Patients who are willing and able to review, understand, and provide written consent
- Patients who agree to comply with all study procedures
- Patients who have access to a mobile phone, tablet, or personal computer, that supports the Headspace application
Exclusion
- Patients with a documented diagnosis of a formal thought disorder (e.g., schizophrenia)
- Patients who are currently or have been in the past three months actively engaged in meditation-related exercises for at least one hour a week
- Patients who are currently receiving psychotherapy
- Patients with pre-existing diagnosis of an inflammatory autoimmune disease such as rheumatoid arthritis, systemic lupus erythematosus, or multiple sclerosis
- Patients who are currently taking adrenergic receptor antagonist (e.g., propranolol) or corticosteroids (e.g., dexamethasone, methylprednisolone)
Key Trial Info
Start Date :
December 5 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 30 2026
Estimated Enrollment :
62 Patients enrolled
Trial Details
Trial ID
NCT03429907
Start Date
December 5 2017
End Date
April 30 2026
Last Update
November 13 2025
Active Locations (1)
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1
University of Texas MD Anderson Cancer Center
Houston, Texas, United States, 77030