MBSR During AI Therapy for Breast Cancer

NCT03253627 | Completed Results

• 2 other identifiers: s17-009954R00NR015473-03
• Study Type: interventional
• Target: 23
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Breast Cancer; Cognitive Symptom

Outcome Measures

Primary Outcomes (1)

• 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

  baseline, 3 months

Other Outcomes (6)

• List Sorting Working Memory Test

  baseline, 6 months

• Flanker Inhibitory Control and Attention Test

  baseline, 6 months

• Cognitive Function

  baseline, 3 months, 6 months

Study Arms (2)

MBSR

EXPERIMENTAL

Mindfulness-Based Stress Reduction

Behavioral: Mindfulness-Based Stress Reduction

Health Enhancement Program

ACTIVE COMPARATOR

Health Enhancement Program

Behavioral: Health Enhancement Program

Interventions

Health Enhancement Program BEHAVIORAL

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

Health Enhancement Program

Mindfulness-Based Stress Reduction BEHAVIORAL

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

MBSR

Eligibility Criteria

• Age: 18 Years - 79 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Female
• \<80 years of age by date of baseline assessment visit
• Able to speak and read English
• Post-menopausal (defined as \[A\] amenorrhea persisting for an entire year, \[B\] oophorectomy or ovarian suppression/ablation, or \[C\] hysterectomy and age \>51 years)
• Diagnosed with DCIS (stage 0) or stage I, II, or III breast cancer
• Post lumpectomy or mastectomy and any re-excisions
• Post neoadjuvant or adjuvant chemotherapy, if prescribed
• Taking aromatase inhibitor (AI) therapy OR AI therapy scheduled to begin before planned post-intervention assessment visit

You may not qualify if:

• Stage IV (metastatic) breast cancer
• Diagnosis of a major psychiatric disorder (e.g., bipolar I disorder, schizophrenia, schizoaffective disorder)
• Suicide attempt within the last 10 years
• Hospitalization or residential treatment for psychiatric illness, eating disorder, or substance abuse within the last 2 years
• History of neurological disease (e.g., Parkinson's disease, dementia)
• History of head trauma
• Claustrophobia
• Unable to lie on the back
• Ever been told not to get an MRI
• MRI-incompatible metal implant\*
• If a potential participant reports implanted metal objects, which might be affected by MRI magnets, the study personnel and MRI technologist will screen over the phone or in person to determine whether the potential participant would be safe during the MRI scan. A current list of implants compatible with MRI will be consulted (http://www.mrisafety.com/TMDL\_list.php).

Sponsors & Collaborators

• New York University: lead
• National Institute of Nursing Research (NINR): collaborator

Study Sites (1)

New York University

New York, New York, 10010, United States

Location

MeSH Terms

Conditions

Breast Neoplasms; Neurobehavioral Manifestations

Interventions

Mindfulness-Based Stress Reduction

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Mindfulness; Cognitive Behavioral Therapy; Behavior Therapy; Psychotherapy; Behavioral Disciplines and Activities

Limitations and Caveats

The sample was less than the anticipated final sample size of 32; it included fewer minority participants than planned. The advent of the COVID-19 pandemic prohibited further recruitment and conduct of this study, which had unavoidable in-person activities (e.g., neuroimaging).

Results Point of Contact

• Title: John Merriman, PhD, RN
• Organization: New York University Meyers College of Nursing

john.merriman@nyu.edu

212-998-5375

Study Officials

• John D Merriman, PhD, RN

  New York University Meyers College of Nursing

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Participants will complete the baseline assessment and be randomly assigned to study group in a permuted block design stratified by receipt of chemotherapy (i.e., two strata). It will not be possible to blind study participants or interventionists to group assignment. To reduce bias, research staff who conduct assessments, including the PI, will be blinded to group assignment (i.e., single blind). Participants will be reminded not to reveal their group assignment to study staff conducting assessments. The study biostatistician will have no direct contact with study participants and will not be blinded to group assignment. The biostatistician will produce and maintain the randomization codes for the permuted blocks. Randomization may only be unmasked by the biostatistician at the completion of data collection, or for reporting of serious adverse events or unanticipated problems for which it will be essential to provide information to the PI on group assignment.
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: A pilot, single-center randomized controlled trial of the preliminary efficacy of an eight-week, group-based Mindfulness-Based Stress Reduction intervention versus Health Enhancement Program active control (i.e., two groups, parallel design) to improve neural markers of changes in cognitive function in postmenopausal women receiving aromatase inhibitor therapy for breast cancer. Participants will be stratified in a permuted block design by receipt of chemotherapy (i.e., two strata). Data will be collected at up to three time points using a repeated measures design (i.e., pre-intervention, post-intervention, approximately three months after the intervention). The study groups will meet at NYU for MBSR or HEP. Neuropsychological, self-report, and biospecimen data collection will be conducted at the Bluestone Center. Neuroimaging data will be collected at the NYU Center for Brain Imaging.

Study Record Dates

• First Submitted: August 8, 2017
• First Posted: August 18, 2017
• Study Start: April 23, 2018
• Primary Completion: December 10, 2019
• Study Completion: September 8, 2020
• Last Updated: November 2, 2022
• Results First Posted: May 19, 2022

Record last verified: 2022-04

Data Sharing

• IPD Sharing: Will share
• 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.

Locations

US (1)