Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| NCI-2018-01079 | Registry Identifier | NCI CTRP |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Hackett Foundation | OTHER |
Not provided
Not provided
Not provided
Not provided
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.
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:
Study Visits - All Participants:
Before you start chemotherapy:
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:
About 6 months after you finish receiving chemotherapy:
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.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| Standard of Care | Other | Questionnaires completed at baseline, at third and at last cycle of chemotherapy, and 6 months after chemotherapy. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Mind-Body Exercises | Behavioral | Participants do daily mind-body exercises for 14 days before starting chemotherapy. The exercises are about 10 minutes per day. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Keri Schadler, PHD | M.D. Anderson Cancer Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Texas MD Anderson Cancer Center | Houston | Texas | 77030 | United States |
Not provided
| Label | URL |
|---|---|
| University of Texas MD Anderson Cancer Center Website | View source |
Not provided
Not provided
| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D011795 | Surveys and Questionnaires |
| ID | Term |
|---|---|
| D003625 | Data Collection |
| D004812 | Epidemiologic Methods |
| D008919 | Investigative Techniques |
| D017531 | Health Care Evaluation Mechanisms |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Questionnaires | Behavioral | Questionnaires completed at baseline, at third and at last cycle of chemotherapy, and 6 months after chemotherapy. |
|
|
| 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. | 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. | 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. | 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 |
| 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. | Baseline up to 6 months after chemotherapy |
| D017437 |
| Skin and Connective Tissue Diseases |
| D011787 | Quality of Health Care |
| D017530 | Health Care Quality, Access, and Evaluation |
| D011634 | Public Health |
| D004778 | Environment and Public Health |