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| ID | Type | Description | Link |
|---|---|---|---|
| UAB | Other Identifier | UAB |
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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:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Breast cancer survivors | Experimental | Younger ER+ breast cancer survivors (BCS), aged 18-50 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Overall percentage rate of recruitment. | To assess the overall percentage rate of recruitment. | baseline, 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Change in psychological distress | Psychological distress will be measured by the Impact of Event Scale-Revised (IES-R). IES-R scale is based on a 22-item scale questionnaire with a cumulative value from 0 to 88, where anything greater than or equal to 24 is considered to have more cancer-related traumatic stress. | Baseline, 6 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Ritu Aneja Professor, Associate Dean, PhD | Contact | 205-934-2277 | raneja@uab.edu | |
| Diviya Bharathi Ravikumar, MBBS | Contact | 770-654-8798 | dbraviku@uab.edu |
| Name | Affiliation | Role |
|---|---|---|
| Ritu Aneja, PhD | University of Alabama at Birmingham | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Alabama at Birmingham | Birmingham | Alabama | 35294 | United States |
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| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| D005221 | Fatigue |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
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| 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. |
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| D017437 |
| Skin and Connective Tissue Diseases |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |