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NCT07501637 · ClinicalTrials.gov registry record · NA
Mind-Body Group Interventions for Psychological Distress in Young Breast Cancer Survivors
A NA study, sponsored by University of Alabama at Birmingham.
- Not yet
- Registry status
- NA
- Development phase
- 30
- Enrollment target
NCT07501637 is a NA study that has not yet begun recruiting, run by University of Alabama at Birmingham. The registered enrollment target is 30 participants.
The verdict
NCT07501637, a NA study, has not yet begun recruiting, sponsored by University of Alabama at Birmingham.
- NOT YET RECRUITING
- Registry status
- NA
- Development phase
- 30 participants
- Enrollment target
Study 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 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 (MSP
Interventions
- BEHAVIORAL Breath-Body-Mind (BBM)
- BEHAVIORAL Survivorship education program (SEP)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 30 participants |
| Start Date | 2026-07-01 |
| Est. Completion | 2027-01-31 |
| Phase | NA |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT07501637
The ClinicalTrials.gov registry entry for NCT07501637 describes a study currently listed as not yet recruiting, categorized as NA. The registered enrollment target is 30 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is University of Alabama at Birmingham, which has 1,160 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Breath-Body-Mind (BBM) is the first listed.
NCT07501637 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT07501637 about?
NCT07501637 is a clinical study titled "Mind-Body Group Interventions for Psychological Distress in Young Breast Cancer Survivors". 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-informe...
What is the current status of trial NCT07501637?
This trial is currently not yet recruiting. It is a NA study. The enrollment target is 30 participants. The study started on 2026-07-01. Estimated completion is 2027-01-31.
What interventions are being tested in trial NCT07501637?
The interventions under investigation include: Breath-Body-Mind (BBM) (BEHAVIORAL), Survivorship education program (SEP) (BEHAVIORAL).
Who is sponsoring clinical trial NCT07501637?
This trial is sponsored by University of Alabama at Birmingham, which has 1,160 total clinical trials registered on ClinicalTrials.gov.
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