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Stress-Reduction Program for Breast Cancer

N/A

Waitlist Available

Led By Cobi J. Heijnen, PHD

Research Sponsored by M.D. Anderson Cancer Center

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Patients who speak English

Women with stage I-III breast cancer who are recommended for neoadjuvant chemotherapy

Must not have

Patients who are currently taking adrenergic receptor antagonist (e.g., propranolol) or corticosteroids (e.g., dexamethasone, methylprednisolone)

Patients with a documented diagnosis of a formal thought disorder (e.g., schizophrenia)

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline up to 6 months after chemotherapy

Awards & highlights

No Placebo-Only Group

Summary

This trial is looking at whether starting a stress-reduction program before cancer treatment can help with stress, mood, and physical symptoms during and after treatment. Up to 140 people will be enrolled at MD Anderson.

Who is the study for?

This trial is for women over 18 with stage I-III breast cancer who are about to start chemotherapy. Participants must speak English, be able to consent, follow study procedures, and have access to a device that supports the Headspace app. It's not for those with autoimmune diseases, current psychotherapy or meditation practices, or taking certain medications.

What is being tested?

The study tests if starting stress-reduction exercises before cancer treatment can help manage stress, mood swings, and physical symptoms during and after therapy. Participants will use mind-body exercises through an app alongside regular questionnaires.

What are the potential side effects?

Since this trial involves mind-body exercises like meditation rather than medication, there are no typical drug side effects; however participants may experience emotional discomfort or increased awareness of stress.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I speak English.

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I am a woman with early to locally advanced breast cancer advised to have chemotherapy before surgery.

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I am 18 years old or older.

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I can use Headspace on my phone, tablet, or computer.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I am currently taking medications like propranolol or corticosteroids.

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I have been diagnosed with a thought disorder like schizophrenia.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline up to 6 months after chemotherapy

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline up to 6 months after chemotherapy

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline up to 6 months after chemotherapy for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

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

Secondary study objectives

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

Associations of patient-reported stress and neuroendocrine biomarkers

Changes in Inflammatory Markers

+2 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Group I: Standard of CareExperimental Treatment1 Intervention

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

Group II: Mind-Body ExercisesExperimental Treatment2 Interventions

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.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Questionnaires

2013

Completed Phase 2

~4280

0 / 6Eligibility criteria met