Malignant Neoplasm of BreastNCT03429907
An Early Stress-Reduction Intervention in Patients With Newly Diagnosed Breast Cancer
A study testing Mind-Body Exercises and Questionnaires in people with Malignant Neoplasm of Breast, run by M.D. Anderson Cancer Center at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Malignant Neoplasm of Breast
- What is being tested?
- Mind-Body Exercises and Questionnaires
- Type of treatment
- Pill or oral medicine, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 62 participants
- Where
- 1 siteUnited States
- Study dates
- 5 Dec 2017to 30 Apr 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Texas MD Anderson Cancer Center
Houston, Texas, 77030
About this study
Official title: An Early Stress-Reduction Intervention in Patients With Newly Diagnosed Breast Cancer: A Randomized Pilot Study
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.
Read the detailed description
Study Groups:
If you agree to take part in this study, you will be randomly assigned (as in the flip of a coin) to 1 of 2 groups. You will have an equal chance of being in either group:
- If you are in Group 1, you will be asked to do daily mind-body exercises for 14 days, beginning before you start receiving chemotherapy. The exercises are short, about 10 minutes per day. The exercises are presented on an online application ("app") that runs on your personal electronic device (such as a mobile phone or tablet). You will be required to install the application on your personal device and to create an account. The study staff will tell you how to perform the exercises, install the application, and create an account. During the 14 days, you will receive automated daily reminders to do the exercises. After you have finished the 14 days of mind-body exercises, you may continue to use the application free of charge for the remainder of the year. After the first year, if you want to keep using the application, you will have to pay for it.
- If you are in Group 2, you will not perform the mind-body exercises. You will be offered one year of free access to the application described above at your last study visit.
Study Visits - All Participants:
Before you start chemotherapy:
- You will complete 10 questionnaires about your stress, mood, physical symptoms, and personality. It should take about 45 minutes to complete all of the questionnaires. You can decide to complete some of the questionnaires from home on a personal computer.
- Information about you (such as age and race) and the disease will be collected from your medical record.
- Blood (about 1 tablespoon) will be drawn for testing of genes and biomarkers that may be related to physical symptoms and mood. Biomarkers are found in the blood and tissue and may help researchers measure the effects of the daily mind-body exercises.
- A hair sample will be taken to measure hormones that are commonly released during times of stress. A lock of hair about the width of a pencil lead will be cut close to your scalp.
- You may be asked to complete a computer task in which you press buttons multiple times in a set time limit. You will receive written instructions on how to complete the task. It should take 15 minutes to complete this task.
At about 15 days after you started the study:
°You will complete one question about your stress. You can complete this question in the clinic or from home on a personal computer.
During chemotherapy:
At about the third month and the sixth month of chemotherapy:
- You will complete 6 questionnaires about your stress, mood, and physical symptoms. It should take about 30 minutes to complete the questionnaires. You can decide to complete these questionnaires from home on a personal computer.
- If your schedule allows for it and you agree, blood (about 1 tablespoon) will be drawn for biomarker testing. If you do not have time to complete this blood draw, it will not affect your participation in this study.
About 6 months after you finish receiving chemotherapy:
- You will complete 8 questionnaires about your stress, mood, and physical symptoms. It should take about 30 minutes to complete the questionnaires.
- Blood (about 1 tablespoon) will be drawn for biomarker testing.
- You may be asked to complete the computer task described above.
Length of Study:
Your participation on this study will be over about 6 months after your last cycle of chemotherapy. If chemotherapy will not be the first treatment you receive for your diagnosis, then your participation on this study will be over at 2 weeks after the start of the study.
- Conditions
- Malignant Neoplasm of Breast
- Being tested
- Mind-Body Exercises, Questionnaires
- Keywords
- Malignant neoplasm of breast, Mind-Body Exercises, Questionnaires, Surveys
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mind-Body ExercisesBehavioural
Participants do daily mind-body exercises for 14 days before starting chemotherapy. The exercises are about 10 minutes per day.
QuestionnairesBehavioural
Also called Surveys
Questionnaires completed at baseline, at third and at last cycle of chemotherapy, and 6 months after chemotherapy.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Behavioral: Questionnaires |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline up to 6 months after chemotherapy
Secondary outcomes (6)
Changes in Inflammatory Markers
To determine the associations of patient-reported outcomes with inflammatory biomarkers, researchers will analyze parallel growth patterns in which correlations between intercept/slope in the PROs and intercept/slope in the biomarkers are tested.
Cortisol assessed in hair samples. In vitro determination of the sensitivity of leukocytes for regulation by cortisol . Blood drawn for plasma levels of biomarkers of immunological activity (C-reactive protein (CRP), IL-6, soluble IL-6 receptor (sIL-6R) TNF-alpha, TNF-receptors I and II (TNF-RI and TNF-RII), and IL-1 receptor antagonist (IL-1RA)), and DAMPs (HSP70, HMGB1, sRAGE). Blood for assessment of cytokine levels in supernatants. Supernatants from T-cells stimulated with anti CD3 and anti CD28 assessed for levels of gamma-interferon, IL-2, IL-10, and IL4. Supernatants from monocytes stimulated with lipopolysaccharide assessed for levels of TNF-alpha and IL-10.
Measured: Baseline up to 6 months after chemotherapy
Associations of patient-reported stress and neuroendocrine biomarkers
Described using cross-sectional Pearson's r correlations and multiple regression models including identified confounding variables.
Cortisol assessed in hair samples. This measure will give insight into the amount of stress experienced in the past month, the time during which the participant was dealing with diagnostic tests and a possible breast cancer diagnosis.
Measured: 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.
Blood for plasma levels of biomarkers of immunological activity (C-reactive protein (CRP), IL-6, soluble IL-6 receptor (sIL-6R) TNF-alpha, TNF-receptors I and II (TNF-RI and TNF-RII), and IL-1 receptor antagonist (IL-1RA)), and DAMPs (HSP70, HMGB1, sRAGE). Blood collected for analysis of mitochondrial function.
Measured: Baseline up to 6 months after chemotherapy
Determine the relation between motivational effort expenditure and the neurotoxic symptom fatigue.
The ratio of high effort/low effort choices on the EEfRT analyzed with Generalized Estimating Equations (GEE) models, which allow for controlling for time-varying covariates such as trial number.
Measured: Baseline up to 6 months after chemotherapy
The association between EEfRT outcome and patient-reported stress and personality characteristics assessed with separate GEE models
Measured: Baseline up to 6 months after chemotherapy
Changes in Mitochondrial Function
To determine the associations of patient-reported outcomes with mitochondrial function, researchers will analyze parallel growth patterns in which correlations between intercept/slope in the PROs and intercept/slope in the biomarkers are tested.
Measured: Baseline up to 6 months after chemotherapy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Feb 2018
- Study start5 Dec 2017
- Primary completion30 Apr 2028 (estimated)
- Study completion30 Apr 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Malignant Neoplasm of BreastStudies of the same condition, open and under way.
- More trials run by M.D. Anderson Cancer CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 62 participants (actual)
Sponsor and investigators
- Lead sponsor
- M.D. Anderson Cancer Center
- Sponsor type
- University, hospital or other
- Collaborators
- Hackett Foundation
- Responsible party
- Sponsor
- Investigators
- Keri Schadler, PHD, Principal investigator, M.D. Anderson Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03429907
- Sponsor's protocol ID
- 2016-0600
- Other IDs
- NCI-2018-01079
- Status last verified
- May 2026
- First submitted
- 24 Jan 2018
- Last updated
- 2 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Early Stress-Reduction Intervention in Patients With Newly Diagnosed Breast Cancer: A Randomized Pilot Study
- ClinicalTrials.gov ID
- NCT03429907
- Acronym / sponsor ID
- 2016-0600
- Conditions
- Malignant Neoplasm of Breast
- Keywords
- Malignant neoplasm of breast, Mind-Body Exercises, Questionnaires, Surveys
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 62 participants (actual)
- Lead sponsor
- M.D. Anderson Cancer CenterUniversity, hospital or other
- Collaborators
- Hackett Foundation
- Study start
- 5 Dec 2017 (actual)
- Primary completion
- 30 Apr 2028 (estimated)
- Study completion
- 30 Apr 2028 (estimated)
- First posted
- 12 Feb 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Study Groups:
If you agree to take part in this study, you will be randomly assigned (as in the flip of a coin) to 1 of 2 groups. You will have an equal chance of being in either group:
- If you are in Group 1, you will be asked to do daily mind-body exercises for 14 days, beginning before you start receiving chemotherapy. The exercises are short, about 10 minutes per day. The exercises are presented on an online application ("app") that runs on your personal electronic device (such as a mobile phone or tablet). You will be required to install the application on your personal device and to create an account. The study staff will tell you how to perform the exercises, install the application, and create an account. During the 14 days, you will receive automated daily reminders to do the exercises. After you have finished the 14 days of mind-body exercises, you may continue to use the application free of charge for the remainder of the year. After the first year, if you want to keep using the application, you will have to pay for it.
- If you are in Group 2, you will not perform the mind-body exercises. You will be offered one year of free access to the application described above at your last study visit.
Study Visits - All Participants:
Before you start chemotherapy:
- You will complete 10 questionnaires about your stress, mood, physical symptoms, and personality. It should take about 45 minutes to complete all of the questionnaires. You can decide to complete some of the questionnaires from home on a personal computer.
- Information about you (such as age and race) and the disease will be collected from your medical record.
- Blood (about 1 tablespoon) will be drawn for testing of genes and biomarkers that may be related to physical symptoms and mood. Biomarkers are found in the blood and tissue and may help researchers measure the effects of the daily mind-body exercises.
- A hair sample will be taken to measure hormones that are commonly released during times of stress. A lock of hair about the width of a pencil lead will be cut close to your scalp.
- You may be asked to complete a computer task in which you press buttons multiple times in a set time limit. You will receive written instructions on how to complete the task. It should take 15 minutes to complete this task.
At about 15 days after you started the study:
°You will complete one question about your stress. You can complete this question in the clinic or from home on a personal computer.
During chemotherapy:
At about the third month and the sixth month of chemotherapy:
- You will complete 6 questionnaires about your stress, mood, and physical symptoms. It should take about 30 minutes to complete the questionnaires. You can decide to complete these questionnaires from home on a personal computer.
- If your schedule allows for it and you agree, blood (about 1 tablespoon) will be drawn for biomarker testing. If you do not have time to complete this blood draw, it will not affect your participation in this study.
About 6 months after you finish receiving chemotherapy:
- You will complete 8 questionnaires about your stress, mood, and physical symptoms. It should take about 30 minutes to complete the questionnaires.
- Blood (about 1 tablespoon) will be drawn for biomarker testing.
- You may be asked to complete the computer task described above.
Length of Study:
Your participation on this study will be over about 6 months after your last cycle of chemotherapy. If chemotherapy will not be the first treatment you receive for your diagnosis, then your participation on this study will be over at 2 weeks after the start of the study.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Mind-Body Exercises | Experimental | Behavioral: Mind-Body Exercises, Behavioral: QuestionnairesParticipants 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. |
| Standard of Care | Other | Behavioral: QuestionnairesQuestionnaires completed at baseline, at third and at last cycle of chemotherapy, and 6 months after chemotherapy. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (5 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Mind-Body ExercisesParticipants do daily mind-body exercises for 14 days before starting chemotherapy. The exercises are about 10 minutes per day. | Behavioural | Mind-Body Exercises |
| QuestionnairesAlso: SurveysQuestionnaires completed at baseline, at third and at last cycle of chemotherapy, and 6 months after chemotherapy. | Behavioural | Mind-Body Exercises, Standard of Care |
Primary outcome
Effect of the Stress-Reduction Intervention on Changes in Patient-Reported Outcomes From T0 to T2 and T3
Time frame: Baseline up to 6 months after chemotherapy
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.
6 secondary outcomes
Changes in Inflammatory Markers
Time frame: Baseline up to 6 months after chemotherapy
Associations of patient-reported stress and neuroendocrine biomarkers
Time frame: 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.
Time frame: Baseline up to 6 months after chemotherapy
Determine the relation between motivational effort expenditure and the neurotoxic symptom fatigue.
Time frame: Baseline up to 6 months after chemotherapy
The association between EEfRT outcome and patient-reported stress and personality characteristics assessed with separate GEE models
Time frame: Baseline up to 6 months after chemotherapy
Changes in Mitochondrial Function
Time frame: Baseline up to 6 months after chemotherapy
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jun 2026.
- University of Texas MD Anderson Cancer Center WebsiteLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Keri Schadler, PHD principal investigator
M.D. Anderson Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Mind-Body Exercises and Questionnaires in people with Malignant Neoplasm of Breast, run by M.D. Anderson Cancer Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 2 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Effect of the Stress-Reduction Intervention on Changes in Patient-Reported Outcomes From T0 to T2 and T3 (time frame: Baseline up to 6 months after chemotherapy). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Jun 2026.