Early Stress-Reduction Intervention in Reducing Stress in Patients with Stage I-III Breast Cancer

Status: closed to accrual

This trial studies how well an early stress-reduction intervention works in reducing stress in patients with stage I-III breast cancer. Starting a stress-reduction program before treatment may affect stress, mood, and physical symptoms during and after treatment for cancer.

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 >= 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

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)

PRIMARY OBJECTIVES:

I. To test the effect of a stress-reduction intervention implemented prior to commencement of chemotherapy on patient-reported neurotoxic somatic (overall symptom severity, fatigue, and cognitive functioning) and depressive symptoms during and after chemotherapy.

SECONDARY OBJECTIVES:

I. To test the effect of a stress-reduction intervention implemented prior to commencement of chemotherapy on changes in peripheral inflammatory biomarkers and leukocyte mitochondrial function during and after chemotherapy.

II. To determine the associations of patient-reported stress and neuroendocrine biomarkers prior to chemotherapy with inflammatory biomarkers, mitochondrial function, and patient-reported neurotoxic somatic and depressive symptoms before, during, and after chemotherapy.

III. To determine the associations of patient-reported neurotoxic somatic and depressive symptoms with inflammatory biomarkers and mitochondrial functioning before, during, and after chemotherapy.

IV. To determine the effect of a stress-reduction intervention implemented prior to commencement of chemotherapy on patient-reported stress two weeks after commencement of the intervention.

V. To determine the relation between motivational effort expenditure and the neurotoxic symptom fatigue.

VI. To determine how personality characteristics (maladaptive traits, trait positive and negative affect, and dispositional mindfulness) and polymorphisms in gene associated to inflammation, neuroregeneration, or dopaminergic neurotransmission influence the effect of a stress-reduction intervention on patient-reported neurotoxic somatic and depressive symptoms during and after chemotherapy.

VII. To determine whether baseline or changes in dispositional mindfulness influence the effect of a stress-reduction intervention on patient-reported neurotoxic somatic and depressive symptoms during and after chemotherapy.

OUTLINE: Patients are randomized to 1 of 2 groups.

GROUP I: Patients complete mind-body exercises over 10 minutes daily for 14 days before starting chemotherapy. Patients also undergo collection of blood samples throughout the trial.

GROUP II: Patients do not complete mind-body exercises before starting chemotherapy. Patients undergo collection of blood samples throughout the trial.

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Early Stress-Reduction Intervention in Reducing Stress in Patients with Stage I-III Breast Cancer

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