Your session is about to expire
← Back to Search
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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline up to 6 months after chemotherapy
Awards & highlights
Study 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.Check my eligibility
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.See study design
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 belowSelect...
I speak English.
Select...
I am a woman with early to locally advanced breast cancer advised to have chemotherapy before surgery.
Select...
I am 18 years old or older.
Select...
I can use Headspace on my phone, tablet, or computer.
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
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Effect of the Stress-Reduction Intervention on Changes in Patient-Reported Outcomes From T0 to T2 and T3
Secondary outcome measures
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
+3 moreTrial 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
~3330
Find a Location
Who is running the clinical trial?
M.D. Anderson Cancer CenterLead Sponsor
2,977 Previous Clinical Trials
1,789,476 Total Patients Enrolled
148 Trials studying Breast Cancer
63,286 Patients Enrolled for Breast Cancer
Hackett FoundationOTHER
Cobi J. Heijnen, PHDPrincipal InvestigatorM.D. Anderson Cancer Center
1 Previous Clinical Trials
24 Total Patients Enrolled
1 Trials studying Breast Cancer
24 Patients Enrolled for Breast Cancer
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am currently undergoing psychotherapy.You have been diagnosed with certain types of inflammatory autoimmune diseases like rheumatoid arthritis, lupus, or multiple sclerosis.I am currently taking medications like propranolol or corticosteroids.I am a woman with early to locally advanced breast cancer advised to have chemotherapy before surgery.I can use Headspace on my phone, tablet, or computer.I speak English.I am 18 years old or older.You have been regularly practicing meditation for at least one hour a week in the past three months.I have been diagnosed with a thought disorder like schizophrenia.
Research Study Groups:
This trial has the following groups:- Group 1: Standard of Care
- Group 2: Mind-Body Exercises
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Recent research and studies
Share this study with friends
Copy Link
Messenger