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

Part of paid clinical trials in Birmingham, Alabama.

Sponsor: University of Alabama at Birmingham
Study ID: NCT07501637
Status: Not Yet Recruiting

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Conditions

Breast Cancer

Eligibility Criteria

Sex: FEMALE
Age: 18 Years - 50 Years
Healthy Volunteers: Not accepted

Interventions

Breath-Body-Mind (BBM) — BEHAVIORAL
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 per minute (cpm), with an equal length of inhalation and exhalation, optimizing HRV. The BBM workshop teaches participants how to become aware of their psychophysiological states and how to use BBM techniques to balance their stress response systems.
Survivorship education program (SEP) — BEHAVIORAL
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 number of contact hours as the BBM intervention. Participants will be asked to reflect on and apply the strategies discussed (e.g., goal setting, self-monitoring) during an 8-week remote follow-up. Participants will meet once a week with the facilitator online in a group education format to discuss challenges and reinforce learning. From week 9 onwards, online group meetings will be offered once a month for 4 months.

Study Details

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).