An Early Stress-Reduction Intervention in Patients With Newly Diagnosed Breast Cancer (NCT03429907) | Clinical Trial Compass
Active — Not RecruitingNot Applicable
An Early Stress-Reduction Intervention in Patients With Newly Diagnosed Breast Cancer
United States62 participantsStarted 2017-12-05
Plain-language 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 an investigational study.
Up to 140 participants will be enrolled in this study. All participants will be recruited at MD Anderson.
Who can participate
Age range
18 Years
Sex
FEMALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. 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 criteria
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Effect of the Stress-Reduction Intervention on Changes in Patient-Reported Outcomes From T0 to T2 and T3
Timeframe: Baseline up to 6 months after chemotherapy
. 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)