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University of Alabama at BirminghamMind-Body Group Interventions for Psychological Distress in Young Breast Cancer Survivors 30 Biomarker-Driven Randomized Wearable Device
Clinical Trial NCT07501637 is an interventional study for Breast Cancer and is currently not yet recruiting. Enrollment is planned to begin on 1 July 2026 and continue until the study accrues 30 participants. Led by University of Alabama at Birmingham, this study is expected to complete by 31 January 2027. The latest data from ClinicalTrials.gov was last updated on 30 March 2026.
Brief Summary
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 ar...Show More
Official Title
Mind-Body Group Interventions for Psychological Distress in Young Breast Cancer Survivors
Conditions
Breast CancerOther Study IDs
- IRB-300016383
- UAB (Other Identifier) (UAB)
NCT ID Number
Start Date (Actual)
2026-07-01
Last Update Posted
2026-03-30
Completion Date (Estimated)
2027-01-31
Enrollment (Estimated)
30
Study Type
Interventional
PHASE
N/A
Status
Not yet recruiting
Keywords
Breast cancer survivors
Breath-Body-Mind
survivorship education program
psychological distress
fatigue
breast cancer
endocrine therapy
Breath-Body-Mind
survivorship education program
psychological distress
fatigue
breast cancer
endocrine therapy
Primary Purpose
Supportive Care
Design Allocation
Randomized
Interventional Model
Parallel
Masking
None (Open Label)
Arms / Interventions
| Participant Group/Arm | Intervention/Treatment |
|---|---|
ExperimentalBreast cancer survivors Younger ER+ breast cancer survivors (BCS), aged 18-50 | 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 br...Show More 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 interv...Show More |
Primary Outcome Measures
Secondary Outcome Measures
| Outcome Measure | Measure Description | Time Frame |
|---|---|---|
Overall percentage rate of recruitment. | To assess the overall percentage rate of recruitment. | baseline, 6 months |
| Outcome Measure | 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 |
Participation Assistant
Eligibility Criteria
Eligible Ages
Adult
Minimum Age
18 Years
Eligible Sexes
Female
- 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.
- 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.
University of Alabama at Birmingham478 active studies to exploreStudy Responsible Party
Ritu Aneja, Principal Investigator, Professor, Associate Dean, University of Alabama at Birmingham
Study Central Contact
Contact: Ritu Aneja Professor, Associate Dean, PhD, 205-934-2277, [email protected]
Contact: Diviya Bharathi Ravikumar, MBBS, 770-654-8798, [email protected]
1 Study Locations in 1 Countries
Alabama
University of Alabama at Birmingham, Birmingham, Alabama, 35294, United States
Ritu Aneja, PhD, Contact, [email protected]