An interventional study of Health Enhancement Program and Mindfulness-Based Stress Reduction in Breast Cancer and Cognitive Symptom, sponsored by New York University. Completed at 1 site in United States. Open to female participants aged 18 Years to 79 Years. Per ClinicalTrials.gov, last updated 2022-11-02.
Sponsored by New York University · Not applicable, Interventional, and Supportive care
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This study will use non-invasive neuroimaging (i.e., MRI) to examine whether Mindfulness-Based Stress Reduction (MBSR) improves neural markers of cognitive function for postmenopausal women taking aromatase inhibitor (AI) therapy for breast cancer. The pilot randomized controlled trial will obtain preliminary efficacy of MBSR versus Health Enhancement Program (HEP) active control to improve neural markers of cognitive function. The final sample will include 32 postmenopausal women with breast cancer. MBSR and HEP groups will meet for a matched schedule of 8 weekly 2.5-hour sessions and a one-day weekend retreat. Specimen and data collection will be done at three time points: pre-randomization (i.e., within three weeks before beginning the intervention), within three weeks after completion of the intervention, and approximately three months (+/- three weeks) post intervention. Change scores for neuroimaging parameter estimates will be correlated with change scores for measures of cognitive function and affect. Differential expression of genes will be correlated with neuroimaging parameter estimates.
Adjuvant aromatase inhibitor (AI) therapy improves disease-free and overall survival for postmenopausal women after surgery for hormone receptor-positive breast cancer. Among symptoms associated with AI therapy are changes in cognitive function. Up to 25% of postmenopausal women with breast cancer report that they experience changes in cognitive function during AI therapy. Studies using neuropsychological tests found subtle deteriorations in verbal and visual learning and memory-as well as concentration, working memory, and executive function-for as many as a third of these patients. Changes in cognitive function may be associated with changes in affect (e.g., worry, depressive symptoms). Neural markers of cognitive changes, including changes in brain function and structure, may underlie changes in cognitive function.
The investigators' recent preliminary neuroimaging work to describe neural markers of cognitive changes suggests that postmenopausal women with breast cancer have inefficient cognitive-emotion processing before AI therapy, as evidenced by greater neural activity in the hippocampus (working memory) and amygdala (emotion processing) during task performance compared to controls. During AI therapy, patients show differential activation compared to controls in the dorsolateral prefrontal cortex (executive function and working memory), medial prefrontal cortices (cortical control of amygdala responses), and hippocampus.
Stress responses could partially explain relationships between AI therapy and neural markers of cognitive changes. The Mindfulness Stress-Buffering Account suggests that interventions such as Mindfulness-Based Stress Reduction (MBSR) may improve stress responses by attenuating negative appraisals of stress and reducing reactivity to stressful situations. For example, mindfulness meditation improved psychological stress responses in women with breast cancer. It improved some measures of cognitive function. Mindfulness practices reduced physiological markers of stress responses, including inflammatory markers in women with breast cancer and in stressed community adults, as well as cortisol reactivity for breast cancer survivors and during chemotherapy for colorectal cancer. Although similar neural deficits as were found in the investigators' preliminary work have been shown to improve in stressed adult populations using MBSR, it is not known whether the intervention improves neural deficits in women taking AI therapy (estrogen, production of which is blocked by AI therapy, is neuroprotective and promotes neural plasticity). Genetic variability was previously found to moderate the effect of MBSR on self-reported cognitive function. Therefore, it is possible that inter-individual variability in the expression of genes involved in stress responses could moderate relationships between AI therapy and neural markers of cognitive changes during MBSR. Taken together, MBSR may improve neural markers of cognitive changes shown in preliminary work to be deficient in postmenopausal women before and during AI therapy for breast cancer by targeting stress responses. Changes in these neural markers may correspond to improved self-report and neuropsychological measures of cognitive function.
Hypothesis: Stress reduction, moderated by gene expression, blunts the impact of AI therapy on neural markers of cognitive function, thereby improving cognitive function and affect in women with breast cancer.
14,832 studies on the registry are indexed under Breast Neoplasms; 3,320 are open to participants now.
This study's enrollment of 23 is below the median of 72 across 10,903 interventional studies indexed under Breast Neoplasms.
Browse Breast Neoplasms studies →New York University is the lead sponsor of 123 studies on the registry; 32 are open to participants now.
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Exclusion Criteria:
MRI-incompatible metal implant*
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Periods have stopped for good: usually no period for 12 months in a row without another medical reason, sometimes confirmed by a blood test (FSH).
Neoadjuvant treatment is given before the main treatment (usually surgery), often to shrink a tumour. Adjuvant treatment is given after it, to lower the chance of the cancer coming back.
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
Postmenopausal
Periods have stopped for good: usually no period for 12 months in a row without another medical reason, sometimes confirmed by a blood test (FSH).
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Adjuvant and neoadjuvant
Neoadjuvant treatment is given before the main treatment (usually surgery), often to shrink a tumour. Adjuvant treatment is given after it, to lower the chance of the cancer coming back.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Metastases
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Mindfulness-Based Stress Reduction
Behavioral: Mindfulness-Based Stress Reduction
Health Enhancement Program
Behavioral: Health Enhancement Program
The HEP control, which was developed to serve as an active control to MBSR, will receive manualized health education from experts in physical activity, functional movement, music therapy, and nutrition-without mindfulness instruction-using similar modalities to MBSR training for a matched schedule.
Also known as: HEP
The MBSR group will receive training from a certified instructor during a group-based, 2.5-hour manualized educational activity weekly for eight weeks. Activities include body scans, gentle stretching, yoga, and mindful awareness. Participants will be asked to complete daily 45-minute, audio-guided mindfulness activities and a one-day weekend retreat to reinforce learning.
Also known as: MBSR
Functional Neural Activation Parameter Estimate
global maximum cluster-level neural activation during task-based functional magnetic resonance imaging for MBSR group compared to Health Enhancement Program group in a whole-brain analysis; paradigm: Emotional Faces N-Back; conditions: happy face distractors minus no face distractors; value has no minimum or maximum; value has no reference ranges; higher values indicate more neural activation
Time frame: baseline, 3 months
List Sorting Working Memory Test
from National Institutes of Health (NIH) Toolbox; Age 7+ v2.1; measures working memory; T-score range 23-77; 50 indicates the population mean with a standard deviation of 10; higher scores indicate better working memory performance; scores below 40 suggest cognitive impairment
Time frame: baseline, 6 months
Flanker Inhibitory Control and Attention Test
from National Institutes of Health (NIH) Toolbox; Age 12+ v2.1; measures attention; T-score range 23-77; 50 indicates the population mean with a standard deviation of 10; higher scores indicate better attention performance; scores below 40 suggest cognitive impairment
Time frame: baseline, 6 months
Cognitive Function
From the Quality of Life in Neurological Disorders (Neuro-QoL) Bank; v2.0; patient-reported outcome; measures executive function and general cognitive concerns; T-score range 17.3-64.2; 50 indicates the population mean with a standard deviation of 10; higher scores indicate better self-reported cognitive function; scores 41-45 suggest mild cognitive impairment, 31-40 suggest moderate cognitive impairment, and 30 or below suggest severe cognitive impairment
Time frame: baseline, 3 months, 6 months
Anxiety
From the Quality of Life in Neurological Disorders (Neuro-QoL) Bank; v1.0; patient reported outcome; T-score range 36.4-76.8; 50 indicates the population mean with a standard deviation of 10; higher scores indicate worse self-reported anxiety; scores 55-59 suggest mild anxiety, 60-69 suggest moderate anxiety, and 70 or above suggest severe anxiety
Time frame: baseline, 3 months, 6 months
Depression
From the Quality of Life in Neurological Disorders (Neuro-QoL) Bank; v1.0; patient-reported outcome; measures depressive symptoms; T-score range 36.9-75.0; 50 indicates the population mean with a standard deviation of 10; higher scores indicate worse depressive symptoms; scores 55-59 suggest mild depressive symptoms, 60-69 suggest moderate depressive symptoms, and 70 or above suggest severe depressive symptoms
Time frame: baseline, 3 months, 6 months
Gene Expression
AMIGO1 gene expression in raw gene counts for MBSR group compared to Health Enhancement Program group in a whole transcriptome analysis using ribonucleic acid sequencing (RNA-Seq); minimum 0, no maximum; value has no reference ranges; higher values indicate more gene expression
Time frame: baseline, 3 months, 6 months
NYU was activated as a site in September 2017. Recruitment and screening began in January 2018. Enrollment started in April 2018 and ended in October 2019. Bellevue Hospital site approval was received in July 2019. Enrollment began then in its affiliated clinics and ended in October 2019.
| Milestone | MBSR | Health Enhancement Program |
|---|---|---|
| Started | 12 | 11 |
| Post-intervention | 11 | 9 |
| Completed | 10 | 7 |
| Not completed | 2 | 4 |
| Withdrew: Lost to follow-up | 1 | 2 |
| Withdrew: Withdrawal by subject | 0 | 2 |
| Withdrew: Inability to complete mri | 1 | 0 |
global maximum cluster-level neural activation during task-based functional magnetic resonance imaging for MBSR group compared to Health Enhancement Program group in a whole-brain analysis; paradigm: Emotional Faces N-Back; conditions: happy face distractors minus no face distractors; value has no minimum or maximum; value has no reference ranges; higher values indicate more neural activation
| beta weights | MBSR | Health Enhancement Program |
|---|---|---|
| baseline | -1.2 ± 2.27 | -1.8 ± 2.28 |
| 3 months | -0.8 ± 1.95 | -0.7 ± 2.27 |
from National Institutes of Health (NIH) Toolbox; Age 7+ v2.1; measures working memory; T-score range 23-77; 50 indicates the population mean with a standard deviation of 10; higher scores indicate better working memory performance; scores below 40 suggest cognitive impairment
| T-score | MBSR | Health Enhancement Program |
|---|---|---|
| baseline | 48.7 ± 6.05 | 51.5 ± 8.57 |
| 6 months | 50.5 ± 8.57 | 56.3 ± 10.75 |
from National Institutes of Health (NIH) Toolbox; Age 12+ v2.1; measures attention; T-score range 23-77; 50 indicates the population mean with a standard deviation of 10; higher scores indicate better attention performance; scores below 40 suggest cognitive impairment
| T-score | MBSR | Health Enhancement Program |
|---|---|---|
| baseline | 46.5 ± 8.17 | 41.9 ± 7.64 |
| 6 months | 43.3 ± 3.83 | 42.4 ± 11.27 |
From the Quality of Life in Neurological Disorders (Neuro-QoL) Bank; v2.0; patient-reported outcome; measures executive function and general cognitive concerns; T-score range 17.3-64.2; 50 indicates the population mean with a standard deviation of 10; higher scores indicate better self-reported cognitive function; scores 41-45 suggest mild cognitive impairment, 31-40 suggest moderate cognitive impairment, and 30 or below suggest severe cognitive impairment
| T-score | MBSR | Health Enhancement Program |
|---|---|---|
| baseline | 47.0 ± 6.49 | 45.9 ± 8.20 |
| 3 months | 45.4 ± 5.12 | 46.0 ± 8.93 |
| 6 months | 47.4 ± 6.37 | 46.4 ± 7.57 |
From the Quality of Life in Neurological Disorders (Neuro-QoL) Bank; v1.0; patient reported outcome; T-score range 36.4-76.8; 50 indicates the population mean with a standard deviation of 10; higher scores indicate worse self-reported anxiety; scores 55-59 suggest mild anxiety, 60-69 suggest moderate anxiety, and 70 or above suggest severe anxiety
| T-score | MBSR | Health Enhancement Program |
|---|---|---|
| baseline | 51.3 ± 5.40 | 53.1 ± 5.96 |
| 3 months | 48.8 ± 6.91 | 53.9 ± 12.28 |
| 6 months | 46.7 ± 7.56 | 50.3 ± 12.66 |
From the Quality of Life in Neurological Disorders (Neuro-QoL) Bank; v1.0; patient-reported outcome; measures depressive symptoms; T-score range 36.9-75.0; 50 indicates the population mean with a standard deviation of 10; higher scores indicate worse depressive symptoms; scores 55-59 suggest mild depressive symptoms, 60-69 suggest moderate depressive symptoms, and 70 or above suggest severe depressive symptoms
| T-score | MBSR | Health Enhancement Program |
|---|---|---|
| baseline | 46.3 ± 6.31 | 45.3 ± 3.24 |
| 3 months | 46.0 ± 6.78 | 49.7 ± 10.41 |
| 6 months | 44.9 ± 7.24 | 48.4 ± 8.91 |
AMIGO1 gene expression in raw gene counts for MBSR group compared to Health Enhancement Program group in a whole transcriptome analysis using ribonucleic acid sequencing (RNA-Seq); minimum 0, no maximum; value has no reference ranges; higher values indicate more gene expression
| raw gene counts | MBSR | Health Enhancement Program |
|---|---|---|
| baseline | 106.1 ± 74.98 | 137.3 ± 77.40 |
| 3 months | 196.0 ± 210.74 | 176.3 ± 114.57 |
| 6 months | 114.4 ± 81.11 | 218.3 ± 86.28 |
Collected over For each participant, adverse event data were collected from the date of enrollment through the final assessment (i.e., approximately 6 months after enrollment).. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| MBSR | 0/12 (0%) | 0/12 (0%) | 0/12 (0%) |
| Health Enhancement Program | 0/11 (0%) | 0/11 (0%) | 0/11 (0%) |
| Age, Continuous(years) | MBSR | Health Enhancement Program | Total |
|---|---|---|---|
| Mean | 65.9 ± 4.85 | 55.6 ± 10.51 | 61 ± 9.46 |
| Sex: Female, Male(Participants) | MBSR | Health Enhancement Program | Total |
|---|---|---|---|
| Female | 12 | 11 | 23 |
| Male | 0 | 0 | 0 |
| Ethnicity (NIH/OMB)(Participants) | MBSR | Health Enhancement Program | Total |
|---|---|---|---|
| Hispanic or Latino | 0 | 1 | 1 |
| Not Hispanic or Latino | 12 | 10 | 22 |
| Unknown or Not Reported | 0 | 0 | 0 |
| Race (NIH/OMB)(Participants) | MBSR | Health Enhancement Program | Total |
|---|---|---|---|
| American Indian or Alaska Native | 0 | 0 | 0 |
| Asian | 1 | 0 | 1 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 |
| Black or African American | 1 | 1 | 2 |
| White | 10 | 10 | 20 |
| More than one race | 0 | 0 | 0 |
| Unknown or Not Reported | 0 | 0 | 0 |
| Region of Enrollment(participants) | MBSR | Health Enhancement Program | Total |
|---|---|---|---|
| United States | 12 | 11 | 23 |
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: Yes — Even though the R00 study is not anticipated to reach the threshold for required genomic data sharing, the study will have in place plans for sharing de-identified data for secondary analyses with qualified investigators. The consent language for the R00 study will be worded for possible broad data sharing.
Time frame: The timeline for submission to an NIH-designated data repository will allow first for publication of findings related to the aims of the R00 study, as well as submission of findings as preliminary data for anticipated grant application(s).
Access criteria: The investigators plan to submit genomic data and relevant phenotypic data (e.g., clinical characteristics of the sample) generated in the R00 study to an NIH-designated data repository in a timely manner. The submission process will likely include registration in the database of Genotypes and Phenotypes (dbGaP) and submission to Gene Expression Omnibus (GEO) for controlled access to the data.
Ran from Apr 2018 to primary completion in Dec 2019, 19 months.
Results were first posted in May 2022, 2 years 5 months after primary completion.
Of 2,663 non-industry interventional studies with no phase under Breast Neoplasms, half reached primary completion within 33 months of starting (the median), counting those still running; a quarter within 16 and three quarters within 66. This study's 19 months is below that.
Counting every sponsor, half of 2,773 studies reached it within 33 months; a quarter within 15 and three quarters within 66.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Apr 2022. You cannot join it, but the record below documents what was studied.
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