Mind-Body Group Interventions for Psychological Distress in Young Breast Cancer Survivors

Overview

This is a two-arm randomized controlled trial (RCT) to determine the feasibility of a larger, fully powered trial in younger ER+ BCS undergoing endocrine therapy in the Deep South and to evaluate preliminary effectiveness of a breath-based group intervention- Breath-Body-Mind (BBM), a trauma-informed program emphasizing slow-paced coherent resonance breathing on psychological and physiological outcomes. The second arm, a survivorship education program (SEP), will serve as an attention-control to match contact time and group setting to control for placebo effects. This project will use multi-source and multimodal data to generate foundational insights into a stress-targeted intervention for an understudied survivorship population. Outcome measures will be assessed across all arms and will include self-reported measures, fMRI, neuro-endocrine-immune blood markers, multi-omics analyses, and physiological measures through a wrist-worn wearable device (GENEActiv). Primary outcomes: 1\) Feasibility of study as measured by rates of enrollment, randomization, retention, and study completion. We will also develop a data collection system and evaluate its usefulness and ability to scale for a future trial. Secondary outcomes: 1\) Change in psychological distress (Impact of Event Scale-Revised, IES-R) related to cancer diagnosis and treatment between baseline and 6 months after workshop. Exploratory outcomes: 1. Fatigue using the Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F) 2. Sleep quality using the Pittsburgh Sleep Quality Index (PSQI) and the GENEActive device 3. Pain using the Brief Pain Index (BPI), 4. Anxiety and depression symptoms using the Hospital Anxiety and Depression Scale (HADS) 5. Medication adherence using the Morisky Medication Adherence Scale 6. Interoceptive awareness using the Multidimensional Assessment of Interoceptive Awareness (MAIA) 7. Perceived social support using the Multidimensional Scale of Perceived Social Support (MSPSS) 8. Neurocognitive function (attention, working memory, processing speed, and executive functioning) using NIH toolbox 9. Overall quality of life will be measured using the Whole Person Health Index (WPHI). 10. Additional cancer-related outcomes will include the Functional Assessment of Cancer Therapy-Endocrine Symptoms (FACT-ES) and the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire-Breast 23 (EORTC QLQ-BR23) body image subscale. 11. The Adverse Childhood Experiences Questionnaire (ACE-Q) and the Big Five Inventory-2 Short Form (BFI-2-S) will be used to assess early life stress and personality traits that may moderate response to the intervention. 12. Peripheral biomarkers will be measured, including inflammatory cytokines (IL-6, TNF-α), neurotrophic factors (BDNF), neuroendocrine hormones (cortisol, oxytocin), fasting cardiometabolic markers (glucose, insulin), and blood pressure. 13. Examine neurobiological mechanisms using resting-state fMRI (brain connectivity changes), and multi-omics profiling (epigenomics, transcriptomics, proteomics, metabolomics).

Interventions

• Behavioral Breath-Body-Mind (BBM)
  The BBM program involves a 12-hour structured training provided virtually, 4 hours/day for 3 consecutive days, followed by 8 weeks of once-a-week online group practice (45 min per session) and daily home practice (20 min per day of coherent breathing with some movement practices). From week 9 onwards, online group practice will be offered once a month for 4 months. BBM entails qigong movements and gentle, coherent breathing (also called Resonance Breathing) through the nose at 5 breath cycles pe
• Behavioral Survivorship education program (SEP)
  This survivorship education program will serve as the control arm. It comprises informational modules focused on recovery after cancer treatment, including managing fatigue and side effects and navigating follow-up care, communication strategies, body image, and planning for long-term wellness. Control participants will have a contact and data acquisition protocol similar to those in the BBM group. The control intervention will also be administered virtually over 3 consecutive days with the same

Primary outcome measures

• Overall percentage rate of recruitment. [Time frame: baseline, 6 months]

Secondary outcome measures (1)

• Change in psychological distress [Time frame: Baseline, 6 months]

Eligibility criteria

Inclusion criteria

• The inclusion criteria for this study will be BCS who are between 18 and 50 years of age with early-stage breast cancer (stage I-III) treated with curative intent.
• They should be within two years of initial diagnosis.
• Patients scoring 0-1 on the Eastern Cooperative Oncology Group (ECOG) scale will be accepted.
• Patients should have completed chemo, surgery, and/or radiation components of their planned therapy regimen at least 6 months ago; they should be positive for estrogen-receptor breast cancer and currently on anti-estrogen therapy (tamoxifen, aromatase inhibitors: letrozole, anastrozole, exemestane).
• Eligible patients will be screened for distress using the IES-R scale. Individuals with scores greater than or equal to 24, will be included in the study.
• Individuals must also be motivated to attend a 3-day virtual workshop, which requires a total commitment of approximately 12 hours virtually.
• They must be willing to participate in a weekly zoom group session for 8-weeks after attending the workshop and then once monthly afterwards up until the 6-month follow up data collection.
• They must be willing to do a 10-20-minute daily practice at home, at least 3 times a week, during the 6-month follow-up period.
• They should also be prepared for three clinical visits (one hour each) for specimen and blood collection at baseline, week 8, and 6 months, as well as three additional visits (15 minutes each) for wearable data upload.
• A subset of participants (n=10) selected for MRI will be screened for claustrophobia and those qualifying (CLQ <25) will be selected for MRI sub-study (exploratory aim of this study).
• If selected for MRI sub-study, two additional clinical visits (one hour each) will be required.

Exclusion criteria

• Male patients are excluded.
• Individuals with a recent history (within past three months) of cardiac arrhythmia, unstable or uncontrolled respiratory disorders such as COPD or asthma, or myocardial infarction, angina.
• Individuals with a recent history (within past three months) of schizophrenia or bipolar disorder, those currently engaging in active substance abuse involving illicit drugs (excluding marijuana), those experiencing active violent ideation, or those on lithium-based medication regimens will also be excluded. Current or recent (within three months) suicidal impulse or suicide attempt is exclusionary, although suicidal ideation without intent or impulse is not.
• Participants with an Eastern Cooperative Oncology Group (ECOG) score of 2 or higher
• Breast cancer patients receiving CDK 4/6 inhibitor-based regimens or GnRH antagonist regimens, will not be eligible.
• Patients with IES-R scores less than or equal to 23 will be excluded from the study.
• Recent surgery (within 3 months) is not excluded unless, in the opinion of the research team, it would substantially interfere with the ability of the person to participate in the intervention.
• Prisoners, pregnant women, and non-English-speaking individuals will not be included.
• A subset of participants (n=10) selected for MRI will be screened for claustrophobia and those with a tendency towards claustrophobic events (CLQ >25) will be excluded from MRI scanning.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Single blind

Primary purpose

Supportive care

Study locations

United States · 1 center

• University of Alabama at Birmingham — Birmingham

Identifiers

NCT: NCT07501637 · IRB-300016383 · UAB

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗