Breath-Body-Mind for Young Breast Cancer Survivors with Psychological Distress

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This randomized controlled trial compares two group interventions in young breast cancer survivors (I-III, ER-positive, on anti-estrogen therapy) to determine feasibility for a larger trial. The Breath-Body-Mind program emphasizes slow breathing and trauma-informed techniques, while the Survivorship Education Program provides an attention control with equal contact time. Outcomes include self-reported distress, functional and physiological measures, and exploratory biomarkers from blood and wearable data collected across all participants. The study uses multi-source data and a virtual delivery format to accommodate geographic location and aims to generate foundational insights for stress-targeted survivorship care.

Why it matters

Who can join: the full rules

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 it's running

• UAB School of Health Professions
  Birmingham, Alabama, United States Recruiting
• University of Alabama at Birmingham O'Neal Cancer Center
  Birmingham, Alabama, United States Recruiting

Study contacts

• Principal investigator: Ritu Aneja, PhD — University of Alabama at Birmingham
• Study coordinator: Ritu Aneja Professor, Associate Dean, PhD
• Email: raneja@uab.edu
• Phone: 205-934-2277

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.