Clinical trial · Interventional
An Early Stress-Reduction Intervention in Patients With Newly Diagnosed Breast Cancer
An Early Stress-Reduction Intervention in Patients With Newly Diagnosed Breast Cancer: A Randomized Pilot Study
NCT03429907CI-TRIAL-00113269active not recruitingN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Malignant Neoplasm of Breast | Malignant Breast Neoplasm | ALIAS | 0.90 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Mind-Body Exercises | Behavioral | — | UNRESOLVED |
| Questionnaires | Behavioral | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Mind-Body Exercises
- description
- Participants do daily mind-body exercises for 14 days before starting chemotherapy. The exercises are presented on an online application ("app") that runs on participant's personal electronic device (such as a mobile phone or tablet). Questionnaires completed at baseline, at third and at last cycle of chemotherapy, and 6 months after chemotherapy.
- interventionNames
- Behavioral: Mind-Body Exercises
- Behavioral: Questionnaires
- type
- OTHER
- label
- Standard of Care
- description
- Questionnaires completed at baseline, at third and at last cycle of chemotherapy, and 6 months after chemotherapy.
- interventionNames
- Behavioral: Questionnaires
Primary outcomes (1)
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: 1. 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. 2. Patients = or \> 18 years old 3. Patients who speak English 4. Patients who are willing and able to review, understand, and provide written consent 5. Patients who agree to comply with all study procedures 6. Patients who have access to a mobile phone, tablet, or personal computer, that supports the Headspace application Exclusion Criteria: 1. Patients with a documented diagnosis of a formal thought disorder (e.g., schizophrenia) 2. 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 3. Patients who are currently receiving psychotherapy 4. Patients with pre-existing diagnosis of an inflammatory autoimmune disease such as rheumatoid arthritis, systemic lupus erythematosus, or multiple sclerosis 5. Patients who are currently taking adrenergic receptor antagonist (e.g., propranolol) or corticosteroids (e.g., dexamethasone, methylprednisolone)
References
Publications (0)
Data not yet available
No reference posted for this study.