NCT07501637 · University of Alabama at Birmingham
Mind-Body Group Interventions for Psychological Distress in Young Breast Cancer Survivors
What this study is about
This is a two-treatment group$1 randomly assigned 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 treatment group$1, 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 treatment group$1 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).
View original scientific description
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 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.
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 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.
Primary outcome measures
Overall percentage rate of recruitment.
Time frame: baseline, 6 months
To assess the overall percentage rate of recruitment.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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.
Where
- Birmingham, Alabama
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Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Oct 16, 2026 · Source of record for eligibility and locations