An Early Stress-Reduction Intervention in Patients With Newly Diagnosed Breast Cancer

NCT03429907 | Active Not Recruiting

• 2 other identifiers: 2016-0600NCI-2018-01079
• Study Type: interventional
• Target: 62
• Locations: 1 country
• Sites: 1

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 an investigational study. Up to 140 participants will be enrolled in this study. All participants will be recruited at MD Anderson.

Conditions

Malignant Neoplasm of Breast

Keywords

Malignant neoplasm of breast; Mind-Body Exercises; Questionnaires; Surveys

Outcome Measures

Primary Outcomes (1)

• Effect of the Stress-Reduction Intervention on Changes in Patient-Reported Outcomes From T0 to T2 and T3

  For the primary objective, changes from T0 to T2 and T3 in neurotoxic somatic symptoms analyzed with multilevel models, in which changes over time are estimated simultaneously across groups.

  Baseline up to 6 months after chemotherapy

Secondary Outcomes (6)

• Changes in Inflammatory Markers

  Baseline up to 6 months after chemotherapy

• Associations of patient-reported stress and neuroendocrine biomarkers

  Baseline up to 6 months after chemotherapy

• Associations of patient-reported neurotoxic somatic and depressive symptoms with inflammatory biomarkers and mitochondrial functioning during and after chemotherapy.

  Baseline up to 6 months after chemotherapy

• Determine the relation between motivational effort expenditure and the neurotoxic symptom fatigue.

  Baseline up to 6 months after chemotherapy

• The association between EEfRT outcome and patient-reported stress and personality characteristics assessed with separate GEE models

  Baseline up to 6 months after chemotherapy

Study Arms (2)

Mind-Body Exercises

EXPERIMENTAL

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.

Behavioral: Mind-Body Exercises; Behavioral: Questionnaires

Standard of Care

OTHER

Questionnaires completed at baseline, at third and at last cycle of chemotherapy, and 6 months after chemotherapy.

Behavioral: Questionnaires

Interventions

Mind-Body Exercises BEHAVIORAL

Participants do daily mind-body exercises for 14 days before starting chemotherapy. The exercises are about 10 minutes per day.

Mind-Body Exercises

Questionnaires BEHAVIORAL

Questionnaires completed at baseline, at third and at last cycle of chemotherapy, and 6 months after chemotherapy.

Also known as: Surveys

Mind-Body Exercises; Standard of Care

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• M.D. Anderson Cancer Center: lead
• Hackett Foundation: collaborator

Study Sites (1)

University of Texas MD Anderson Cancer Center

Houston, Texas, 77030, United States

Location

Related Links

• University of Texas MD Anderson Cancer Center Website

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Surveys and Questionnaires

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Data Collection; Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health

Study Officials

• Keri Schadler, PHD

  M.D. Anderson Cancer Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 24, 2018
• First Posted: February 12, 2018
• Study Start: December 5, 2017
• Primary Completion (Estimated): April 30, 2028
• Study Completion (Estimated): April 30, 2028
• Last Updated: June 2, 2026

Record last verified: 2026-05

Locations

US (1)