Trial Outcomes & Findings for MBSR During AI Therapy for Breast Cancer (NCT NCT03253627)

Last Updated: 2022-11-02

Results Overview

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

Recruitment status

COMPLETED

Study phase

Target enrollment

23 participants

Primary outcome timeframe

baseline, 3 months

Results posted on

2022-11-02

Participant Flow

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.

Participant milestones

Participant milestones
Measure	MBSR Mindfulness-Based Stress Reduction Mindfulness-Based Stress Reduction: 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.	Health Enhancement Program Health Enhancement Program 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.
Overall Study STARTED	12	11
Overall Study Post-intervention	11	9
Overall Study COMPLETED	10	7
Overall Study NOT COMPLETED	2	4

Reasons for withdrawal

Reasons for withdrawal
Measure	MBSR Mindfulness-Based Stress Reduction Mindfulness-Based Stress Reduction: 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.	Health Enhancement Program Health Enhancement Program 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.
Overall Study Lost to Follow-up	1	2
Overall Study Withdrawal by Subject	0	2
Overall Study Inability to complete MRI	1	0

Baseline Characteristics

MBSR During AI Therapy for Breast Cancer

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	MBSR n=12 Participants Mindfulness-Based Stress Reduction Mindfulness-Based Stress Reduction: 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.	Health Enhancement Program n=11 Participants Health Enhancement Program 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.	Total n=23 Participants Total of all reporting groups
Age, Continuous	65.9 years STANDARD_DEVIATION 4.85 • n=5 Participants	55.6 years STANDARD_DEVIATION 10.51 • n=7 Participants	61 years STANDARD_DEVIATION 9.46 • n=5 Participants
Sex: Female, Male Female	12 Participants n=5 Participants	11 Participants n=7 Participants	23 Participants n=5 Participants
Sex: Female, Male Male	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	12 Participants n=5 Participants	10 Participants n=7 Participants	22 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	1 Participants n=5 Participants	1 Participants n=7 Participants	2 Participants n=5 Participants
Race (NIH/OMB) White	10 Participants n=5 Participants	10 Participants n=7 Participants	20 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Region of Enrollment United States	12 participants n=5 Participants	11 participants n=7 Participants	23 participants n=5 Participants

PRIMARY outcome

Timeframe: baseline, 3 months

Population: participants with usable neuroimaging data after quality control

Outcome measures

Outcome measures
Measure	MBSR n=10 Participants Mindfulness-Based Stress Reduction Mindfulness-Based Stress Reduction: 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.	Health Enhancement Program n=8 Participants Health Enhancement Program 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.
Functional Neural Activation Parameter Estimate baseline	-1.2 beta weights Standard Deviation 2.27	-1.8 beta weights Standard Deviation 2.28
Functional Neural Activation Parameter Estimate 3 months	-0.8 beta weights Standard Deviation 1.95	-0.7 beta weights Standard Deviation 2.27

OTHER_PRE_SPECIFIED outcome

Timeframe: baseline, 6 months

Population: differences in sample size due to attrition

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

Outcome measures

Outcome measures
Measure	MBSR n=12 Participants Mindfulness-Based Stress Reduction Mindfulness-Based Stress Reduction: 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.	Health Enhancement Program n=11 Participants Health Enhancement Program 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.
List Sorting Working Memory Test baseline	48.7 T-score Standard Deviation 6.05	51.5 T-score Standard Deviation 8.57
List Sorting Working Memory Test 6 months	50.5 T-score Standard Deviation 8.57	56.3 T-score Standard Deviation 10.75

OTHER_PRE_SPECIFIED outcome

Timeframe: baseline, 6 months

Population: Differences in sample size due to attrition

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

Outcome measures

Outcome measures
Measure	MBSR n=12 Participants Mindfulness-Based Stress Reduction Mindfulness-Based Stress Reduction: 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.	Health Enhancement Program n=11 Participants Health Enhancement Program 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.
Flanker Inhibitory Control and Attention Test baseline	46.5 T-score Standard Deviation 8.17	41.9 T-score Standard Deviation 7.64
Flanker Inhibitory Control and Attention Test 6 months	43.3 T-score Standard Deviation 3.83	42.4 T-score Standard Deviation 11.27

OTHER_PRE_SPECIFIED outcome

Timeframe: baseline, 3 months, 6 months

Population: Differences in sample size due to attrition

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

Outcome measures

Outcome measures
Measure	MBSR n=12 Participants Mindfulness-Based Stress Reduction Mindfulness-Based Stress Reduction: 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.	Health Enhancement Program n=11 Participants Health Enhancement Program 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.
Cognitive Function 6 months	47.4 T-score Standard Deviation 6.37	46.4 T-score Standard Deviation 7.57
Cognitive Function baseline	47.0 T-score Standard Deviation 6.49	45.9 T-score Standard Deviation 8.20
Cognitive Function 3 months	45.4 T-score Standard Deviation 5.12	46.0 T-score Standard Deviation 8.93

OTHER_PRE_SPECIFIED outcome

Timeframe: baseline, 3 months, 6 months

Population: Differences in sample size due to attrition

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

Outcome measures

Outcome measures
Measure	MBSR n=12 Participants Mindfulness-Based Stress Reduction Mindfulness-Based Stress Reduction: 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.	Health Enhancement Program n=11 Participants Health Enhancement Program 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.
Anxiety baseline	51.3 T-score Standard Deviation 5.40	53.1 T-score Standard Deviation 5.96
Anxiety 3 months	48.8 T-score Standard Deviation 6.91	53.9 T-score Standard Deviation 12.28
Anxiety 6 months	46.7 T-score Standard Deviation 7.56	50.3 T-score Standard Deviation 12.66

OTHER_PRE_SPECIFIED outcome

Timeframe: baseline, 3 months, 6 months

Population: Differences in sample size due to attrition

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

Outcome measures

Outcome measures
Measure	MBSR n=12 Participants Mindfulness-Based Stress Reduction Mindfulness-Based Stress Reduction: 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.	Health Enhancement Program n=11 Participants Health Enhancement Program 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.
Depression baseline	46.3 T-score Standard Deviation 6.31	45.3 T-score Standard Deviation 3.24
Depression 3 months	46.0 T-score Standard Deviation 6.78	49.7 T-score Standard Deviation 10.41
Depression 6 months	44.9 T-score Standard Deviation 7.24	48.4 T-score Standard Deviation 8.91

OTHER_PRE_SPECIFIED outcome

Timeframe: baseline, 3 months, 6 months

Population: participants with usable gene expression data after quality control

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

Outcome measures

Outcome measures
Measure	MBSR n=9 Participants Mindfulness-Based Stress Reduction Mindfulness-Based Stress Reduction: 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.	Health Enhancement Program n=9 Participants Health Enhancement Program 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.
Gene Expression 6 months	114.4 raw gene counts Standard Deviation 81.11	218.3 raw gene counts Standard Deviation 86.28
Gene Expression baseline	106.1 raw gene counts Standard Deviation 74.98	137.3 raw gene counts Standard Deviation 77.40
Gene Expression 3 months	196.0 raw gene counts Standard Deviation 210.74	176.3 raw gene counts Standard Deviation 114.57

Adverse Events

MBSR

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Health Enhancement Program

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

John Merriman, PhD, RN

New York University Meyers College of Nursing

Phone: 212-998-5375

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place