Review the details below, then apply to join this clinical trial.
At a Glance
Age
18 – 50
Sex
Female
Study type
Interventional
Purpose
Supportive Care
Participants needed
30 (estimated)
Sponsor
University of Alabama at Birmingham · Other
Who this trial is looking for
This trial is looking for younger women who have survived breast cancer and are experiencing psychological distress. Participants will attend a 3-day virtual workshop and take part in weekly online group sessions for two months.
Are You a Good Fit for This Trial?
Must be takingTamoxifenLetrozoleAnastrozoleExemestane
Rules you outCardiac arrhythmiaUncontrolled respiratory disorderSuicidal impulseCDK 4/6 inhibitorsGnRH antagonists
You may be able to join if
I am a woman aged 18 to 50.
I've been diagnosed with early-stage breast cancer.
I am within two years of my initial diagnosis.
I have completed my cancer treatment at least 6 months ago.
I am currently on anti-estrogen therapy.
I have a score of 24 or higher for distress.
I can commit to a 12-hour virtual workshop.
I am willing to practice daily at home for the study.
You may not be able to join if
I am male.
I have had a heart problem in the last 3 months.
I have a recent history of schizophrenia or bipolar disorder.
I am using illegal drugs or have recent violent thoughts.
I have a score of 2 or higher on the ECOG scale.
I am currently receiving certain cancer treatments.
I have a score of 23 or lower for distress.
I am pregnant.
Summarized in plain language from this trial's official eligibility criteria.
The full criteria are further down this page — only the research team can
confirm whether you qualify.
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Answer three quick questions written from this study's own rules to see if you may qualify. No account needed to find out.
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 out…
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).
Trial Locations
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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 Oncolog…
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.
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